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The Human Medicines Regulations 2012

Status:

Point in time view as at 01/07/2022.

Changes to legislation:

The Human Medicines Regulations 2012 is up to date with all changes known to be in force on or before 22 December 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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SCHEDULES

Regulation 5

SCHEDULE 1U.K.Further provisions for classification of medicinal products

PART 1U.K.Descriptions of certain medicinal products to be available only on prescription

1.  The following medicinal products shall be available only on prescription—U.K.

(a)a product for parenteral administration;

(b)a product that is a controlled drug [F1as defined in section 2(1)(a) of the Misuse of Drugs Act 1971], unless it is covered by a [F2UK] marketing authorisation in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale;

(c)cyanogenic substances, other than preparations for external use;

(d)medicinal substances that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;

(e)a product that—

(i)is covered by a [F3UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence] in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii)consists of or contains aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules;

(f)a product that—

(i)is covered by a [F4UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence] in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and

(ii)consists of or contains (in any pharmaceutical form) pseudoephedrine salts or ephedrine base or salts; F5...

(g)a product that—

(i)is not covered by a [F6UK marketing authorisation, EU marketing authorisation, Article 126a authorisation or parallel import licence], and

(ii)is a prescription only medicine by virtue of articles 5 and 10 of, and Schedules 1 and 2 to, the Prescription Only Medicines (Human Use) Order 1997 M1 [F7; F8...]

[F9(h)a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, the product is classified as a prescription only medicine [F10; and]]

[F11(i)an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, the product is classified as a prescription only medicine.]

Textual Amendments

F1Words in Sch. 1 para. 1(b) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 10 and words in Sch. 1 para. 1(b) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 10

Marginal Citations

2.  In this Part “cyanogenic substances” means preparations which—U.K.

(a)are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17; or

(b)contain more than 0.1 per cent by weight of any substance having the formula either—

(i)alpha-Cyanobenzyl -6-O-Beta-d-glucopyranosyl -Beta-d-glucopyranoside, or

(ii)alpha-Cyanobenzyl -Beta-d-glucopyranosiduronic acid.

PART 2U.K.Descriptions of certain medicinal products to be available only from a pharmacy

3.  The following medicinal products shall be available only from a pharmacy—U.K.

(a)a product comprising eye ointment;

(b)a product that contains Vitamin A, Vitamin A acetate or Vitamin A palmitate, in each case with a maximum daily dose equivalent to more than 7500 international units of Vitamin A or 2250 micrograms of retinol;

(c)a product that contains Vitamin D with a maximum daily dose of more than 400 units of antirachitic activity [F12; F13...]

[F14(d)a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, it is only to be available from a pharmacy [F15; and]]

[F16(e)an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, it is only to be available from a pharmacy.]

Textual Amendments

4.  The following medicinal products shall be available only from a pharmacy unless they are the subject of a [F17UK marketing authorisation, EU marketing authorisation, Article 126a authorisation, parallel import licence] or traditional herbal registration that classifies them as medicinal products subject to general sale—U.K.

(a)a product that is for use as an anthelmintic;

(b)a product that is for parenteral administration;

(c)a product that is for use as an enema;

(d)a product that is for use wholly or mainly for irrigation of—

(i)wounds, or

(ii)the bladder, vagina or rectum;

(e)a product that is for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.

Textual Amendments

5.  A medicinal product shall be available only from a pharmacy if it is a medicinal product of a kind specified in Schedule 15 but is not presented for sale in accordance with the requirements specified in that Schedule for a product of that kind to be subject to general sale.U.K.

Regulation 16

SCHEDULE 2U.K.Supplementary provision relating to advisory bodies and expert advisory groups

Terms of appointmentU.K.

1.—(1) The person appointed to chair an advisory body is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).U.K.

(2) The person's term of office as chair of the advisory body is not to exceed the person's term of office as a member of the body.

(3) The person may resign from chairing the advisory body at any time by notice in writing to the Ministers.

2.—(1) A member of an advisory body, other than its chair, is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).U.K.

(2) The term of an appointment may not exceed four years (but an appointment may be renewed).

(3) A member of an advisory body may resign from it at any time by notice in writing to the Ministers.

(4) Where a person ceases to be a member of an advisory body, the person also ceases to be a member of any expert advisory group appointed by the advisory body (including an expert advisory group appointed jointly with the other advisory body).

(5) But sub-paragraph (4) does not apply if—

(a)the person was a member of the advisory body only by virtue of being co-opted under regulation 13; or

(b)the person is immediately re-appointed to the advisory body.

3.—(1) The person appointed to chair an expert advisory group is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (2) and (3)).U.K.

(2) The person's term of office as chair of the expert advisory group is not to exceed the person's term of office as a member of the group.

(3) The person may resign from chairing the group at any time by notice in writing to the advisory body or bodies which appointed the group.

4.—(1) This paragraph applies to a member of an expert advisory group, other than a person appointed to chair an expert advisory group.U.K.

(2) The member is to hold and vacate office in accordance with the written terms of the appointment (but this is subject to sub-paragraphs (3) and (4)).

(3) The term of an appointment may not exceed four years (but an appointment may be renewed).

(4) The member may resign office at any time by notice in writing to the advisory body or bodies which appointed the group.

Facilities and proceedingsU.K.

5.  The Ministers must provide each advisory body with such staff, accommodation, services and other facilities as the Ministers think necessary or expedient for the proper performance of its functions.U.K.

6.  The validity of any proceedings of an advisory body or expert advisory group is not affected by—U.K.

(a)a vacancy among its members; or

(b)a defect in the appointment of any member.

7.—(1) An advisory body may, subject to approval by the Secretary of State, make such provision as it thinks fit for the regulation of its own proceedings.U.K.

(2) The licensing authority may make provision for the regulation of the proceedings of an expert advisory group.

Payment and expensesU.K.

8.  The Ministers may pay to the members of each advisory body and expert advisory group such remuneration (if any) and such allowances as may be determined by the Ministers with the consent of the Treasury.U.K.

9.  The Ministers must defray any expenses incurred with their approval by each advisory body and expert advisory group.U.K.

10.  If an action is brought against a person arising out of an act performed as a member of an advisory body or expert advisory group, the Ministers may indemnify that person against any damages, costs or expenses incurred in that action.U.K.

11.  Paragraphs 8 to 10 shall have effect in relation to an expert committee appointed by the licensing authority and to its members as if they were an advisory body or expert advisory group and its members.U.K.

StatusU.K.

12.  An advisory body or expert advisory group is not to be regarded—U.K.

(a)as a servant or agent of the Crown; or

(b)as enjoying any status, immunity or privilege of the Crown.

Regulations 8(1) and B17(3)

[F18SCHEDULE 2AU.K.Modifications of Commission Directive 2003/94/EC

Textual Amendments

Provision of Commission Directive 2003/94/ECModification subject to which that provision is to be read
Article 1 (scope)

The reference to—

(a) “Article 40 of Directive 2001/83/EC” is to be read as a reference to “regulation 17 of the Human Medicines Regulations 2012”; and

(b) “Article 13 of Directive 2001/20/EC” is to be read as a reference to “regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.

Article 2 (definitions)

In the definition of—

(a) “medicinal product”, the reference to “Article 1(2) of Directive 2001/83/EC” is to be read as a reference to “regulation 2 of the Human Medicines Regulations 2012”;

(b) “investigational medicinal product”, the reference to “Article 2(d) of Directive 2001/20/EC” is to be read as a reference to “regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

(c) “manufacturer” the reference to “Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC” is to be read as a reference to “regulation 17(1) of the Human Medicines Regulations 2012 or the authorisation referred to in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

(d) “qualified person” the reference to “Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC” is to be read as a reference to “regulation 41 of the Human Medicines Regulations 2012 or regulation 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.

Article 3(1) (inspections)

The reference to—

(a) “for Article 111(1) of Directive 2001/83/EC” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 (enforcement)”;

(b) “Article 15(1) of Directive 2001/20/EC” is to be read as a reference to “Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (enforcement)”;

(c) “the Member States”, is to be read as a reference to “the licensing authority”;

(d) “Member States shall” is to be read as a reference to “The licensing authority may”;

(e) “published by the Commission, of Community procedures on inspections and exchanges of information” is to be read as if after it there were inserted “or any guidance published by the licensing authority to replace that Commission guidance”.

Article 3(2) (inspections)

The reference to—

(a) “competent authorities” is to be read as a reference to “licensing authority”;

(b) “the second paragraph of Article 47 of Directive 2001/83/EC” to the end is to be read as a reference to “regulation C17(1)(a) of the Human Medicines Regulations 2012, or which applies by virtue of regulation C17(2) of those Regulations”.

Article 4(2) (conformity with good manufacturing practice)

The reference to—

(a) “third countries” is to be read as a reference to “country other than the United Kingdom”;

(b) “Community” is to be read as a reference to “licensing authority”.

Article 5 (compliance with marketing authorisation)

The reference to—

(a) “Article 9(2) of Directive 2001/20/EC” in both places it appears is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

(b) “competent authorities” in both places it appears is to be read as a reference to “licensing authority”.

Article 9 (documentation)

The reference in—

(a) paragraph (1) to “Article 51(3) of Directive 2001/83/EC” is to be read as a reference to “paragraph 15(1) of Schedule 7 to the Human Medicines Regulations 2012”;

(b) paragraph (2) to “competent authorities” is to be read as a reference to “licensing authority”.

Article 11 (quality control)

The reference in paragraph (2)—

(a) to “point (b) of Article 20 of Directive 2001/83/EC” is to be read as a reference to “paragraph 3 or 17 of Schedule 4 to the Human Medicines Regulations 2012”;

(b) to “Article 9(2) of Directive 2001/20/EC” is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”;

The reference in paragraph (4)—

(a) to “Member State” is to be read as a reference to “United Kingdom”;

(b) to “competent authority” is to be read as a reference to “licensing authority”;

Article 12(4) (work contracted out)

The reference to—

(a) “competent authorities” is to be read as a reference to “licensing authority”;

(b) “for Article 111 of Directive 2001/83/EC and Article 15(1) of Directive 2001/20/EC” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 or Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.

Article 13 (complaints, product recall and emergency unblinding)The reference to “Article 123 of Directive 2001/83/EC” is to be read as a reference to “Part 5 of the Human Medicines Regulations 2012”.]

Regulation 21(1)

SCHEDULE 3U.K.Applications for licences under Part 3

Manufacturer's licencesU.K.

1.—(1) This paragraph applies to an application for a manufacturer's licence relating to the manufacture or assembly of medicinal products.U.K.

(2) The application must contain—

(a)the name and address of the applicant;

(b)the name and address of the person (if any) making the application on the applicant's behalf;

(c)the address of each of the premises where any operations to which the licence relates are to be carried out;

(d)the address of any premises not mentioned by virtue of paragraph (c) where—

(i)the applicant proposes to keep any living animals, from which a substance used in the production of the medicinal product to which the application relates is to be derived, or

(ii)materials of animal origin, from which a substance is to be derived as mentioned in sub-paragraph (i), are to be kept;

(e)the address of each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(f)the name, address, qualifications and experience of the person (“S”) whose duty it will be to supervise the manufacturing or assembling operations, and the name and job title of the person to whom S reports;

[F19(g)the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of—

(i)in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or

(ii)in the case of a product for sale or supply in Northern Ireland, the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products,

a statement of that fact);]

(h)the name, address and qualifications of the person to be responsible for any animals kept as mentioned in sub-paragraph (d)(i);

(i)the name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of medicinal products;

(j)the name, address and qualifications of the qualified person.

(3) The application must also contain—

(a)the pharmaceutical form of each medicinal product to be manufactured or assembled;

(b)details of the manufacturing or assembling operations to which the licence is to relate, including a statement of whether they include—

(i)the manufacture of medicinal products, or

(ii)the assembly of medicinal products;

(c)a statement of whether the medicinal products are to be manufactured or assembled for the purpose of—

(i)being administered to human beings in that form, or

(ii)as an ingredient in the preparation of another medicinal product;

(d)a statement of the facilities and equipment available at each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(e)a separate statement, in respect of each of the premises mentioned in the application, of—

(i)the manufacturing or assembling operations capable of being carried out at those premises, and the class of medicinal products to which those operations relate, and

(ii)the equipment available at those premises for carrying out each stage of those operations;

(f)a statement of the authority conferred on the person mentioned in sub-paragraph (2)(g) to reject unsatisfactory medicinal products;

(g)a description of the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly and for the storage of medicinal products after manufacture or assembly;

(h)a description of the arrangements, at each of the premises where the applicant proposes to store medicinal products, for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(i)a description of the arrangements for maintaining—

(i)production records, and

(ii)records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials used in manufacture, or of medicinal products, with the specification for such materials or medicinal products;

(j)a description of the arrangements for keeping reference samples of—

(i)materials used in the manufacture of medicinal products, and

(ii)medicinal products;

(k)where the application relates to an exempt advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable the linking of a product to the patient who received it and vice versa; and

(l)details of—

(i)any manufacturing operations, other than those to which the licence is to relate, carried on by the proposed licence holder on or near the premises mentioned in sub-paragraph (2)(c), and

(ii)the substances or articles to which those operations relate.

Textual Amendments

Manufacturers' licence relating to importU.K.

2.—[F20(1) This paragraph applies to an application for a manufacturer's licence relating to the import from—U.K.

(a)in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b)in the case of an import into Northern Ireland, a country other than an EEA State,

of medicinal products.]

(2) The application must contain—

(a)the name and address of the applicant;

(b)the name and address of the person (if any) making the application on the applicant's behalf;

(c)the name, pharmaceutical form, country of origin and marketing authorisation number of each imported medicinal product;

(d)the address of each set of premises where the importation operation is to take place;

(e)the address of each set of premises where any testing associated with the importation is to take place;

(f)the address of each set of premises where medicinal products are to be stored, or from which they are to be distributed;

(g)the name, address and qualifications of the qualified person; and

(h)the name, address, qualifications and experience of the person in charge of quality control.

(3) The application must also contain—

(a)details of the importation operations to which the licence is to relate;

(b)a statement of the facilities and equipment available at each set of premises where medicinal products are to be stored, or from which they are to be distributed;

(c)details of—

(i)any manufacturing of medicinal products carried on by the applicant on or near the premises mentioned in sub-paragraph (2)(d) to (f), and

(ii)the substances or articles manufactured or used in the manufacturing;

(d)a description of the arrangements for storage of the medicinal products after importation;

(e)a description of the arrangements at each set of premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(f)a description of the arrangements for maintaining—

(i)records of importation, and

(ii)records of analytical and other procedures applied in the course of importation; and

(g)a description of the arrangements for keeping reference samples of the medicinal products.

Textual Amendments

Wholesale dealer's licencesU.K.

3.—(1) This paragraph applies to an application for a wholesale dealer's licence.U.K.

(2) The application must contain—

(a)the name and address of the applicant;

(b)the name and address of the person (if any) making the application on the applicant's behalf;

(c)the address of each of the premises where medicinal products are to be stored, or from which they are to be distributed; and

(d)the name, address and qualifications of the responsible person [F21or the responsible person (import)].

(3) The application must also contain—

(a)details of the distribution by way of wholesale dealing to which the licence is to relate;

(b)a statement of whether the medicinal products to which the distribution relates are the subject of—

[F22(i)in the case of a product for sale or supply in Great Britain, a UK marketing authorisation,

(ia)in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,]

(ii)a certificate of registration,

(iii)a traditional herbal registration, or

(iv)[F23in the case of a product for sale or supply in Northern Ireland,] an Article 126a authorisation;

[F24(v)an authorisation granted by an authority in a country other than the United Kingdom to sell or supply the medicinal product in that other country;]

(c)a statement of whether the medicinal products to which the distribution relates are—

(i)prescription only medicines,

(ii)pharmacy medicines, or

(iii)medicines subject to general sale;

(d)a statement of whether the medicinal products to which the distribution relates are—

(i)special medicinal products, F25...

[F26(ia)EAMS medicinal products,]

(ii)sold or supplied pursuant to regulation 174 (supply in response to spread of pathogenic agents [F27etc), or]

[F28(iii)to be distributed by means of export from Great Britain to an approved country for import;]

(e)a statement of whether the medicinal products dealt in under the licence are to be used—

(i)for administration to human beings, or

(ii)as ingredients in the preparation of medicinal products for administration to human beings;

(f)an indication of the range of medicinal products to be stored at each of the premises mentioned in the application;

(g)a statement of the facilities and equipment available at those premises for storing and distributing medicinal products;

(h)a description of the arrangements at those premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products (whether by the maintenance of records or by other means);

(i)details of an emergency plan which satisfies the requirements of regulation 43(7)(b), and

(j)a description of the arrangements for keeping records relating to products received or dispatched.

[F29(4) In sub-paragraph (2)(d)—

“the responsible person” means the person who has the functions described in regulation 45(2);

“the responsible person (import)” means the person who has the functions described in regulation 45AA(4).]

Textual Amendments

F22Sch. 3 para. 3(3)(b)(i)(ia) substituted for Sch. 3 para. 3(3)(b)(i) by S.I. 2019/775, regs. 1, 18(4)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(i))

All licencesU.K.

4.—(1) If an application does not include information or other matters required under this Schedule, the application must state—U.K.

(a)why that information is not applicable; or

(b)any other reason for not including them.

(2) An application for a licence must be in English.

(3) The pages of an application for a licence must be serially numbered.

(4) The applicant must sign the application.

(5) If the application is made by another person on behalf of the applicant, that person must also sign the application.

Regulation 24

SCHEDULE 4U.K.Standard provisions of licences under Part 3

PART 1U.K.Manufacturer's licence relating to manufacture and assembly

1.  The provisions of this Part are standard provisions of a manufacturer's licence relating to the manufacture or assembly of medicinal products.U.K.

2.  The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 1(2)(g) of Schedule 3.U.K.

3.  The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if the laboratory is operated by a person approved by the licensing authority.U.K.

4.  The licence holder must provide such information as may be requested by the licensing authority—U.K.

(a)about the products currently being manufactured or assembled by the licence holder; and

(b)about the operations being carried out in relation to such manufacture or assembly.

5.  The licence holder must inform the licensing authority of any change that the licence holder proposes to make to a person named in the licence as—U.K.

(a)the person whose duty it is to supervise the manufacturing or assembling operations;

(b)in charge of the animals from which are derived substances used in the production of the medicinal products being manufactured or assembled; or

(c)responsible for the culture of living tissues used in the manufacture of the medicinal products being manufactured or assembled.

6.  The licence holder must—U.K.

(a)keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

(b)permit the authorised person to take copies or make extracts from such documentation.

7.  The licence holder must keep readily available for examination by a person authorised by the licensing authority the samples in each batch of finished medicinal product referred to in Article 11(4) of the Good Manufacturing Practice Directive.U.K.

8.  Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with—U.K.

(a)the specification for the finished product; or

(b)the provisions of these Regulations applicable to the medicinal product,

the holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for a period (not exceeding six weeks) specified by the licensing authority.

9.  The licence holder must ensure that tests for determining conformity with the standards and specifications applying to a product used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that product otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage of the manufacture as may be approved by the licensing authority.U.K.

10.  Where the manufacturer's licence relates to the assembly of a medicinal product or class of product, and the licence holder supplies the product at such a stage of assembly that does not fully comply with the provisions of the product specification which relate to labelling, the licence holder must communicate the particulars of those provisions to the person to whom that product has been supplied.U.K.

11.  Where—U.K.

(a)the manufacturer's licence relates to the assembly of a medicinal product;

(b)the medicinal product is not manufactured by the licence holder; and

(c)particulars of the name and address of the manufacturer of the product, or the person who imports the product, have been given by the licence holder to the licensing authority,

the licence holder must immediately notify the licensing authority in writing of any changes in the particulars.

12.  The licence holder must keep readily available for examination by a person authorised by the licensing authority durable records of the details of the manufacture of intermediate products held by the licence holder for use in the manufacture of biological medicinal products, and the records must—U.K.

(a)be in such form as to ensure that the licence holder has a comprehensive record of all matters that are relevant to an evaluation of the safety, quality and efficacy of a finished biological medicinal product manufactured using those intermediate products; and

(b)not be destroyed without the consent of the licensing authority until the records of the details of manufacture of finished medicinal products which were or may be manufactured using those intermediate products may be destroyed in accordance with the requirements of these Regulations.

13.  Where—U.K.

(a)animals are used in the production of medicinal products; and

[F30(b)in the case of a product for sale or supply—

(i)in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii)in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

contains provisions relating to them,]

the manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.

Textual Amendments

14.  The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided to the licensing authority is not false or misleading in any material particular if—U.K.

(a)it relates to a medicinal product which the licence holder manufactures or assembles; or

(b)it relates to any starting materials or intermediate products held by the licence holder which are for use in the manufacture of medicinal products.

[F3114A.  A licence holder—U.K.

(a)in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b)in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

[F3214B.  A licence holder may only manufacture or assemble EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.]U.K.

Textual Amendments

PART 2U.K.Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State [F33/ Country other than an Approved Country for Import]

Textual Amendments

15.  The provisions of this Part are standard provisions of a manufacturer's licence relating to the import of medicinal products [F34from—U.K.

(a)in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b)in the case of an import into Northern Ireland, a country other than an EEA State].

Textual Amendments

F34Sch. 4 para. 15(a)(b) substituted for words in Sch. 4 para. 15 (31.12.2020) by S.I. 2019/775, reg. 20(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(d))

[F3515A.  The provisions of this Part are standard provisions of a manufacturer’s licence relating to the supply of a listed NIMAR product from Great Britain to Northern Ireland.]U.K.

Textual Amendments

16.  The licence holder must place the quality control system referred to in Article 11(1) of the Good Manufacturing Practice Directive under the authority of the person notified to the licensing authority in accordance with paragraph 2(2)(h) of Schedule 3.U.K.

17.  The licence holder may use a contract laboratory pursuant to Article 11(2) of the Good Manufacturing Practice Directive if operated by a person approved by the licensing authority.U.K.

18.  The licence holder must provide such information as may be requested by the licensing authority concerning the type and quantity of any medicinal products which the licence holder imports.U.K.

19.  The licence holder must—U.K.

(a)keep readily available for inspection by a person authorised by the licensing authority the batch documentation referred to in Article 9(1) of the Good Manufacturing Practice Directive; and

(b)permit the person authorised to take copies or make extracts from such documentation.

20.  Where the licence holder has been informed by the licensing authority that the strength, quality or purity of a batch of a medicinal product to which the licence relates has been found not to conform with—U.K.

(a)the specification of the medicinal product in question; or

(b)those provisions of these Regulations that are applicable to the medicinal product,

the licence holder must, if so directed, withhold the batch from distribution, so far as reasonably practicable, for such a period (not exceeding six weeks) as may be specified by the licensing authority.

21.  The licence holder must ensure that any tests for determining conformity with the standards and specifications applying to any ingredient used in the manufacture of a medicinal product must, except so far as the conditions of the product specification for that ingredient otherwise provide, be applied to samples taken from the medicinal product after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the licensing authority.U.K.

22.—(1) Where and in so far as the licence relates to special medicinal products, the licence holder may only import such products from [F36, in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State]—U.K.

(a)in response to an order which satisfies the requirements of regulation 167 (supply to fulfil special patient needs); and

(b)where the conditions set out in sub-paragraphs (2) to (9) are complied with.

(2) No later than 28 days before the day on which each importation of a special medicinal product takes place, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—

(a)the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b)any trademark or the name of the manufacturer of the medicinal product;

(c)in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d)the quantity of medicinal product to be imported, which must not exceed the quantity specified in sub-paragraph (6); and

(e)the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.

(3) The licence holder may not import the special medicinal product if, before the end of 28 days beginning immediately after the date on which the licensing authority sends or gives the licence holder an acknowledgement in writing by the licensing authority that it has received the notice referred to in sub-paragraph (2), the licensing authority has notified the licence holder in writing that the product should not be imported.

(4) The licence holder may import the special medicinal product referred to in the notice where the licence holder has been notified in writing by the licensing authority, before the end of the 28-day period referred to in sub-paragraph (3) that the product may be imported.

(5) Where the licence holder sells or supplies special medicinal products [F37or EAMS medicinal products], the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—

(a)the batch number of the batch of the product from which the sale or supply was made; and

(b)details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.

(6) The licence holder must not, on any one occasion, import more than such amount as is sufficient for 25 single administrations, or for 25 courses of treatment where the amount imported is sufficient for a maximum of three months' treatment, and must not, on any one occasion, import more than the quantity notified to the licensing authority under sub-paragraph (2)(d).

(7) The licence holder must not publish any advertisement, catalogue or circular relating to a special medicinal product [F38or EAMS medicinal product] or make any representations in respect of that product.

(8) The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product [F39or EAMS medicinal product] imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.

(9) The licence holder must cease importing or supplying a special medicinal product [F40or EAMS medicinal product] if the licence holder receives a notice in writing from the licensing authority directing that, from a date specified in the notice, a particular product or class of products may no longer be imported or supplied.

(10) In this paragraph—

“British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia: lists of names);

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and

“monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards and “current” in this definition means current at the time the notice is sent to the licensing authority.

Textual Amendments

23.  The licence holder must take all reasonable precautions and exercise due diligence to ensure that any information provided to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a medicinal product for human use which is imported from [F41, in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State], handled, stored or distributed under the licence is not false or misleading in a material particular.U.K.

Textual Amendments

[F4223ZA.  The licence holder in Great Britain must take all reasonable precautions and exercise due diligence to ensure that any information provided to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a product for human use which is supplied from Great Britain into Northern Ireland by virtue of regulation 167A handled, stored or distributed under the licence is not false or misleading in a material particular.]U.K.

Textual Amendments

[F4323A.  A licence holder—U.K.

(a)in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b)in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

[F4423B.  A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.]U.K.

Textual Amendments

PART 3U.K.Manufacturer's licence relating to exempt advanced therapy medicinal products

24.  The provisions of paragraphs 25 to 27 are incorporated as additional standard provisions of a manufacturer's licence relating to the manufacture and assembly of exempt advanced therapy medicinal products.U.K.

25.  The licence holder must ensure that the immediate packaging of an exempt advanced therapy medicinal product is labelled to show the following particulars—U.K.

(a)the name of the exempt advanced therapy medicinal product;

(b)the expiry date in clear terms including the year and month and, if applicable, the day;

(c)a description of the active substance, expressed qualitatively and quantitatively;

(d)where the product contains cells or tissues of human or animal origin—

(i)a statement that the product contains such cells or tissues, and

(ii)a short description of the cells or tissues and of their specific origin;

(e)the pharmaceutical form and the contents by weight, volume or number of doses of the product;

(f)a list of excipients, including preservative systems;

(g)the method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated;

(h)any special storage precautions;

(i)specific precautions relating to the disposal of the unused product or waste derived from the product and, where appropriate, reference to any appropriate collection system;

(j)the name and address of the holder of the manufacturer's licence;

(k)the manufacturer's licence number;

(l)the manufacturer's batch number;

(m)the unique donation code [F45assigned by a tissue establishment pursuant to—

(a)paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b)paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells]; and

(n)where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

Textual Amendments

26.  The licence holder must ensure that the package leaflet of the exempt advanced therapy medicinal product shall include the following particulars—U.K.

(a)the name of the exempt advanced therapy medicinal product;

(b)the intended effect of the medicinal product if correctly used, applied, administered or implanted;

(c)where the product contains cells or tissues of human or animal origin—

(i)a statement that the product contains such cells or tissues, and

(ii)a short description of the cells or tissues and, where such cells or tissues are of animal origin, their specific origin;

(d)where the product contains a medical device or an active implantable medical device, a description of that device and, where that device contains cells or tissues of animal origin, their specific origin;

(e)any necessary instructions for use, including—

(i)the posology,

(ii)the method of use, application, administration or implantation and, if appropriate, the route of administration,

(iii)a description of symptoms of overdose,

(iv)action to be taken in the event of overdose, including any emergency procedures,

(v)action to be taken if one or more doses have been missed, and

(vi)a recommendation to consult the doctor or pharmacist for any clarification on the use of the product;

(f)where adverse reactions are known, a description of those which may occur under recommended conditions of use of the product and, if appropriate, an indication of action to be taken in such a case;

(g)an instruction that the patient report any adverse reaction not specified in the package leaflet to the doctor or pharmacist;

(h)the expiry date in clear terms and a warning against using the product after that date;

(i)any special storage precautions;

(j)a description of any visible signs of deterioration;

(k)a complete qualitative and quantitative composition;

(l)the name and address of the holder of the manufacturer's licence; and

(m)the date on which the package leaflet was last revised.

27.  The licence holder must keep the data referred to in paragraph 8 of Schedule 6 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.U.K.

PART 4U.K.Wholesale dealer's licence

All wholesale dealer's licencesU.K.

28.  The provisions of this Part are standard provisions of a wholesale dealer's licence.U.K.

29.  The licence holder must not use any premises for the handling, storage or distribution of medicinal products other than those specified in the licence or notified to the licensing authority from time to time and approved by the licensing authority.U.K.

30.  The licence holder must provide such information as may be requested by the licensing authority concerning the type and quantity of medicinal products which the licence holder handles, stores or distributes.U.K.

31.  The licence holder must take all reasonable precautions and exercise all due diligence to ensure that any information provided by the licence holder to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of a medicinal product which the licence holder handles, stores or distributes is not false or misleading.U.K.

Wholesale dealer's licence relating to special medicinal productsU.K.

32.  The provisions of paragraphs 33 to 42 are incorporated as additional standard provisions of a wholesale dealer's licence relating to special medicinal products.U.K.

33.  Where and in so far as the licence relates to special medicinal products, the licence holder may only import such products from [F46, in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State]—U.K.

(a)in response to an order which satisfies the requirements of regulation 167, and

(b)where the conditions set out in paragraphs 34 to 41 are complied with.

Textual Amendments

[F4733A.  A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.]U.K.

Textual Amendments

34.  No later than 28 days prior to each importation of a special medicinal product, the licence holder must give written notice to the licensing authority stating the intention to import the product and stating the following particulars—U.K.

(a)the brand name, common name or scientific name of the medicinal product and (if different) any name under which the medicinal product is to be sold or supplied in the United Kingdom;

(b)any trademark or the name of the manufacturer of the medicinal product;

(c)in respect of each active constituent of the medicinal product, any international non-proprietary name or the British approved name or the monograph name, or where that constituent does not have any of those, the accepted scientific name or any other name descriptive of the true nature of the constituent;

(d)the quantity of medicinal product to be imported, which must not exceed the quantity specified in paragraph 38; and

(e)the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported and, if the person who will supply the medicinal product for importation is not the manufacturer or assembler, the name and address of the supplier.

35.  The licence holder may not import the special medicinal product if, before the end of 28 days beginning immediately after the date on which the licensing authority sends or gives the licence holder an acknowledgement in writing by the licensing authority that it has received the notice referred to in paragraph 34, the licensing authority has notified the licence holder in writing that the product should not be imported.U.K.

36.  The licence holder may import the special medicinal product referred to in the notice where the licence holder has been notified in writing by the licensing authority, before the end of the 28-day period referred to in paragraph 35, that the product may be imported.U.K.

37.  Where the licence holder sells or supplies special medicinal products [F48or EAMS medicinal products], the licence holder must, in addition to any other records which are required by the provisions of the licence, make and maintain written records relating to—U.K.

(a)the batch number of the batch of the product from which the sale or supply was made; and

(b)details of any adverse reaction to the product sold or supplied of which the licence holder becomes aware.

Textual Amendments

38.  The licence holder must not, on any one occasion, import more than such amount as is sufficient for 25 single administrations, or for 25 courses of treatment where the amount imported is sufficient for a maximum of three months' treatment, and must not, on any one occasion, import more than the quantity notified to the licensing authority under paragraph 34(d).U.K.

39.  The licence holder must inform the licensing authority immediately of any matter coming to the licence holder's attention which might reasonably cause the licensing authority to believe that a special medicinal product [F49or EAMS medicinal product] imported in accordance with this paragraph can no longer be regarded as a product which can safely be administered to human beings or as a product which is of satisfactory quality for such administration.U.K.

Textual Amendments

40.  The licence holder must not publish any advertisement, catalogue, or circular relating to a special medicinal product [F50or EAMS medicinal product] or make any representations in respect of that product.U.K.

Textual Amendments

41.  The licence holder must cease importing or supplying a special medicinal product [F51or EAMS medicinal product] if the licence holder receives a notice in writing from the licensing authority directing that, from a date specified in the notice, a particular product or class of products may no longer be imported or supplied.U.K.

Textual Amendments

[F5241A.  A licence holder—U.K.

(a)in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and

(b)in Northern Ireland may only supply a special medicinal product to a person in Great Britain,

in response to an order which satisfies the requirements of regulation 167.]

Textual Amendments

42.  In this Part—U.K.

“British approved name” means the name which appears in the current edition of the list prepared by the British Pharmacopoeia Commission under regulation 318 (British Pharmacopoeia- lists of names);

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle; and

“monograph name” means the name or approved synonym which appears at the head of a monograph in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or a foreign or international compendium of standards, and “current” in this definition means current at the time the notice is sent to the licensing authority.

Wholesale dealer's licence relating to exempt advanced therapy medicinal productsU.K.

43.  The provisions of paragraph 44 are incorporated as additional standard provisions of a wholesale dealer's licence relating to exempt advanced therapy medicinal products.U.K.

44.  The licence holder shall keep the data referred to in paragraph 16 of Schedule 6 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.U.K.

Regulation 27; Schedule 11paragraphs 11(3), 13(3),23(4) and 30(4)

SCHEDULE 5U.K.Review upon oral representations

Application of this ScheduleU.K.

[F531.—(1) This Schedule applies if a person (“the applicant”) mentioned in sub-paragraph (2) notifies the licensing authority that the applicant wishes the licensing authority to submit the proposal or as the case may be the decision to review upon oral representations under—U.K.

(a)regulation 27(3)(b);

(b)regulation 45H(3)(b);

(c)regulation 45R(3)(b);

(d)regulation 256J(4)(b); or

(e)Part 1, 2 or 3 of Schedule 11.

(2) Those persons are—

(a)in respect of notification under regulation 27(3)(b) the licence holder;

(b)in respect of a notification under regulation 45H(3)(b) the person registered as a broker;

(c)in respect of a notification under regulation 45R(3)(b) the person with an active substance registration;

(d)in respect of a notification under regulation 256J(4)(b) the person on the list in accordance with Part 12A; and

(e)in respect of a notification under Part 1, 2 or 3 of Schedule 11—

(i)an applicant for a UK marketing authorisation, [F54parallel import licence,] certificate of registration or traditional herbal registration,

(ii)an applicant for the renewal of an authorisation, [F55licence,] certificate or registration, and

(iii)the holder of an authorisation, [F55licence,] certificate or registration.]

Textual Amendments

Appointment of reviewersU.K.

2.—(1) The licensing authority must—U.K.

(a)appoint a panel of at least two persons (“the reviewers”) to conduct the review; and

(b)provide facilities for the applicant to have the opportunity to appear before the reviewers.

(2) A person must not be appointed under sub-paragraph (1) if within the period of one year immediately preceding that time the person has been a member of—

(a)the Commission;

(b)an expert committee appointed by the licensing authority;

(c)an expert advisory group;

(d)the British Pharmacopoeia Commission or any of its sub-committees;

(e)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Medicines Act 1968; or

(f)the Herbal Medicines Advisory Committee formerly established under section 4 of the Medicines Act 1968.

(3) A person appointed under sub-paragraph (1) must not be an officer or servant of a Minister of the Crown, the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister.

Procedure before hearingU.K.

3.—(1) The applicant must supply the reviewers with a written summary of the oral representations that the applicant wishes to make and any documents on which the applicant wishes to rely in support of them before the end of the period of three months beginning with the date of the notification mentioned in paragraph 1.U.K.

(2) The reviewers may, at the request of the applicant and after consulting the licensing authority, extend the period mentioned in sub-paragraph (1) up to a maximum of six months beginning with the date of that notification.

(3) The applicant may submit additional written representations or documents after the end of the periods for doing so only with the permission of the reviewers.

(4) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the representations and documents referred to in paragraphs (1) and (3)—

(a)must not be based on any evidence or data that was not available to the licensing authority at the time that the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority; unless

(b)the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(5) The reviewers must notify the applicant and the licensing authority of the date of the hearing at least 28 days before that date, unless the applicant and the licensing authority agree to a shorter period of notice.

(6) The reviewers may establish at any stage of the procedures described in this Schedule a date by which all of those procedures, except for the hearing, must be completed, and notify this date to the applicant and to the licensing authority.

(7) The date established under sub-paragraph (6) must not be earlier than whichever is the earlier of—

(a)the first day after the end of the period of three months beginning with the date of the notification mentioned in paragraph 1; or

(b)the first day after the end of the period of 28 days beginning with the date on which the reviewers receive the written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1) and (3) of this paragraph,

and in any case not earlier than the first day after the period of seven days beginning on the day after the notification under sub-paragraph (6).

(8) A date established under sub-paragraph (6) may be varied or withdrawn on the application of the applicant or of the licensing authority.

(9) In the case of a decision or a proposal by the licensing authority under Part 1, 2 or 3 of Schedule 11, the reviewers must not take into account any documents or other evidence, or any representations based on such documents or evidence, in the conduct of the hearing if it thinks that the data or evidence on which the documents or representations are based, or the evidence that is presented, were not available to the licensing authority at the time when the decision or, as the case may be, the proposal that is the subject of the review was notified to the applicant by the licensing authority, unless the evidence or data is unfavourable in respect of the safety, quality or efficacy of the product concerned.

(10) The reviewers may give such other directions as they think fit for the conduct of the hearing, including—

(a)the postponing or adjournment of the hearing for such period as it may decide; and

(b)establishing a list of documents that will be taken into account in the conduct of the hearing.

(11) If the applicant fails to comply with a time limit under sub-paragraph (1), (2) or (6)—

(a)the applicant may not appear before the reviewers; and

(b)the licensing authority must decide whether—

(i)to proceed with its proposal to revoke, vary or suspend the licence,

(ii)to confirm or alter its decision,

F56(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv)to grant or renew the UK marketing authorisation, [F57parallel import licence,] certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application, F58...

(v)to revoke, vary or suspend the authorisation, [F59licence,] certificate or registration,

[F60(vi)to proceed to suspend, vary or remove the person’s broker registration,

(vii)ro proceed to suspend, vary or remove the person’s active substance registration, or

(viii)to proceed to suspend, vary or remove the person’s entry on the list,]

as the case may be.

(12) The licensing authority must notify the applicant of its decision.

Textual Amendments

F58Word in Sch. 5 para. 3(11)(b)(iv) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(i)

F60Sch. 5 para. 3(11)(b)(vi)-(viii) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(b)(ii)

Procedure at hearingU.K.

4.—(1) Both the applicant and the licensing authority may make representations at the hearing.U.K.

(2) The hearing must be in public if the applicant so requests.

(3) If the applicant fails to appear at the hearing, the reviewers may conduct the review on the basis of the applicant's written summary of the oral representations and supporting documents submitted in accordance with sub-paragraphs (1), (2) and (3) of paragraph 3.

Procedure following hearingU.K.

5.—(1) After the hearing the reviewers must provide a report to the licensing authority and to the applicant either—U.K.

(a)by the end of the period of 60 days beginning with the day after the conclusion of the hearing; or

(b)within such further period as the reviewers may notify to the licensing authority and to the applicant within that 60 day period.

(2) The licensing authority must take the report into account and decide whether—

(a)to proceed with its proposal to revoke, vary or suspend the licence;

(b)to confirm or alter its decision;

F61(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)to grant or renew the UK marketing authorisation, [F62parallel import licence,] certificate of registration or traditional herbal registration or to do so otherwise than in accordance with the application; F63...

[F64(e)to revoke, vary or suspend the authorisation, certificate or registration;

(f)to proceed to suspend, vary or remove a person’s broker registration;

(g)to proceed to suspend, vary or remove a person’s active substance registration; or

(h)to proceed to suspend, vary or remove a person’s entry on the list,]

as the case may be.

(3) The licensing authority must notify the applicant of its decision.

Textual Amendments

F63Word in Sch. 5 para. 5(2)(d) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(c)(i)

F64Sch. 5 para. 5(2)(e)-(h) substituted for Sch. 5 para. 5(2)(e) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(c)(ii)

Regulations 36(3) and 42(3)

SCHEDULE 6U.K.Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products

PART 1U.K.Manufacturer's licences

1.  The requirements in paragraphs 2 to 12 apply to a manufacturer's licence insofar as it relates to the manufacture and assembly of exempt advanced therapy medicinal products.U.K.

2.  The licence holder must inform the licensing authority of any adverse reaction or suspected adverse reaction of which the holder is aware within the period of 15 days beginning on the day following the first day on which the holder knew about the reaction.U.K.

3.  The licence holder must ensure, if using human cells or tissues in an exempt advanced therapy medicinal product, that the donation, procurement and testing of those cells or tissues is in accordance with [F65requirements imposed pursuant to—U.K.

(a)paragraphs 6 to 9 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b)paragraphs 9 to 12 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.]

Textual Amendments

4.  The licence holder must ensure that any human tissue or cell component imported into the United Kingdom and used by the holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product shall meet equivalent standards of quality and safety to those [F66imposed pursuant to—U.K.

(a)Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards gametes and embryos; and

(b)Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other tissues and cells.]

Textual Amendments

5.  The licence holder must ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer's licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product meets equivalent standards of quality and safety to those laid down in [F67the Blood Quality and Safety Regulations 2005].U.K.

Textual Amendments

6.  Where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence that person must comply with—U.K.

(a)the requirements of paragraphs 15, 16, 18 and 19; and

(b)the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;

as if that person were the holder of a wholesale dealer's licence.

7.  The licence holder must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks related to the exempt advanced therapy medicinal product.U.K.

8.  The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used.U.K.

9.  The licence holder must, subject to paragraph 27 of Schedule 4, keep the data referred to in paragraph 8 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.U.K.

10.  The licence holder must secure that the data referred to in paragraph 8 will, in the event that—U.K.

(a)the licence is suspended, revoked or withdrawn; or

(b)the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a manufacturer's licence for the period described in paragraph 9 or such longer period as may be required pursuant to paragraph 27 of Schedule 4.

11.  The licence holder must, where an exempt advanced therapy medicinal product contains human cells or tissues, ensure that the traceability system established in accordance with paragraph 8 is complementary to and compatible with the requirements [F68imposed pursuant to—U.K.

(a)as regards gametes and embryos, sections 12(3), and 33A to 33D of, and paragraph 1 of Schedule 3A to, the Human Fertilisation and Embryology Act 1990;

(b)as regards blood cells, regulations 8, 9(e) and 14 of the Blood Safety and Quality Regulations 2005; and

(c)as regards other cells and tissues, regulations 13 and 16 of, and paragraph 1 of Schedule 2 to, the Human Tissue (Quality and Safety for Human Application) Regulations 2007].

Textual Amendments

12.  The licence holder must not import or export any exempt advanced therapy medicinal product.U.K.

PART 2U.K.Wholesale dealer's licences

13.  The requirements in paragraphs 14 to 20 apply to a wholesale dealer's licence insofar as it relates to exempt advanced therapy medicinal products.U.K.

14.  The licence holder must obtain supplies of exempt advanced therapy medicinal products only from—U.K.

(a)the holder of a manufacturer's licence in respect of those products; or

(b)the holder of a wholesale dealer's licence in respect of those products.

15.  The licence holder must distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to—U.K.

(a)the holder of a wholesale dealer's licence in respect of those products; or

(b)a person who—

(i)may lawfully administer those products, and

(ii)solicited the product for an individual patient.

16.  The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used.U.K.

17.  The licence holder must inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer's licence of which the holder is aware.U.K.

18.  The licence holder must, subject to paragraph 44 of Schedule 4, keep the data referred to in paragraph 16 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.U.K.

19.  The licence holder must secure that the data referred to in paragraph 16 will, in the event that—U.K.

(a)the licence is suspended, revoked or withdrawn; or

(b)the licence holder becomes bankrupt or insolvent,

be held available to the licensing authority by the holder of a wholesale dealer's licence for the period described in paragraph 18 or such longer period as may be required pursuant to paragraph 44 of Schedule 4.

20.  The licence holder must not import or export any exempt advanced therapy medicinal product.U.K.

Regulation 41

SCHEDULE 7U.K.Qualified persons

PART 1U.K.Qualification requirements for qualified person

1.  A person must satisfy the requirements in paragraphs 2 and 8 or, alternatively, the requirements in paragraphs 7 and 8, of this Schedule before acting as a qualified person (but this is subject to Part 2).U.K.

2.  The person must have a degree, diploma or other formal qualification which satisfies the requirements of this Part, in one of the following subjects—U.K.

(a)pharmacy;

(b)medicine;

(c)veterinary medicine;

(d)chemistry;

(e)pharmaceutical chemistry and technology; or

(f)biology,

but this paragraph is subject to paragraph 7.

3.  A qualification satisfies the requirements of this Part if it is awarded on completion of a university course of study, or a course recognised as equivalent by [F69the licensing authority], which—U.K.

(a)satisfies the minimum requirements specified in paragraph 4; and

(b)extends over a period of at least four years of theoretical and practical study of a subject specified in paragraph 2 (but this is subject to paragraphs 5 and 6).

Textual Amendments

4.—(1) A course should include at least the following core subjects—U.K.

(a)experimental physics;

(b)general and inorganic chemistry;

(c)organic chemistry;

(d)analytical chemistry;

(e)pharmaceutical chemistry, including analysis of medicinal products;

(f)general and applied medical biochemistry;

(g)physiology;

(h)microbiology;

(i)pharmacology;

(j)pharmaceutical technology;

(k)toxicology; and

(l)pharmacognosy.

(2) The subjects mentioned in sub-paragraph (1) should be balanced in such a way as to enable the person to fulfil the obligations specified in Part 3 of this Schedule.

5.  If the course referred to in paragraph 3 is followed by a period of theoretical and practical training of at least one year, including a training period of at least six months in a pharmacy open to the public and a final examination at university level, the minimum duration of the course is three and a half years.U.K.

6.  If two university courses, or courses recognised as of university equivalent standard, co-exist, one of which extends over four years and the other over three years, the three-year course is to be treated as fulfilling the condition as to the duration of the course in paragraph 3, provided that [F70the licensing authority] recognises the formal qualifications gained from each course as being equivalent.U.K.

Textual Amendments

7.  If the person's formal qualifications do not satisfy the requirements of this Part, the person may act as a qualified person if the licensing authority is satisfied, on the production of evidence, that the person has adequate knowledge of the subjects specified in paragraph 4(1).U.K.

8.—(1) The person must (subject to sub-paragraph (2)) have at least two years' practical experience in an undertaking authorised to manufacture medicinal products of—U.K.

(a)qualitative analysis of medicinal products;

(b)quantitative analysis of active substances; and

(c)the testing and checking necessary to ensure the quality of medicinal products.

(2) But—

(a)if the person has completed a university course lasting at least five years, the minimum period of practical experience under this paragraph is one year; and

(b)if the person has completed a university course lasting at least six years, the minimum period of practical experience under this paragraph is six months.

PART 2U.K.Qualified persons with long experience

9.—(1) This paragraph applies to a person who has acted as a qualified person since the coming into force of Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products M2.U.K.

(2) A person to whom this paragraph applies may continue to act as a qualified person.

Marginal Citations

M2OJ No L 147, 9.6.1975, p.13, no longer in force.

10.—(1) This paragraph applies to a person who—U.K.

(a)holds a degree, diploma or other formal qualification in a scientific discipline awarded on completion of a university course or course recognised as equivalent; and

(b)began the course before 21 May 1975.

(2) A person to whom this paragraph applies may act as a qualified person provided that sub-paragraph (3) (and, where applicable, paragraph 11) is satisfied.

(3) This sub-paragraph is satisfied if, for at least two years before 21 May 1985, the person has carried out one of the following activities in an undertaking authorised to manufacture medicinal products—

(a)production supervision;

(b)qualitative and quantitative analysis of active substances; or

(c)testing and checking, under the direct supervision of the qualified person in respect of the undertaking, to ensure the quality of the medicinal products.

11.  If a person to whom paragraph 10 applies acquired the practical experience mentioned in paragraph 10(3) before 21 May 1965, the person must complete a further one year's practical experience of the kind specified in that paragraph immediately before the person may act as a qualified person.U.K.

PART 3U.K.Obligations of qualified person

12.—[F71(1)] [F72In Great Britain, the qualified person] is responsible for securing—

(a)that each batch of medicinal products manufactured in [F73Great Britain] has been manufactured and checked in accordance with these Regulations and the requirements of the [F74UK marketing authorisation], certificate of registration or traditional herbal registration [F75, or an equivalent authorisation,] relating to those products; F76... [F77and]

(b)in the case of [F78medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import], that each batch has undergone—

(i)a full qualitative analysis,

(ii)a quantitative analysis of all the active substances, and

(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the [F79UK marketing authorisation], certificate of registration or traditional herbal registration [F80, or an equivalent authorisation,] relating to those products; [F81and]

F82(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F83(2) In this paragraph “equivalent authorisation” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.]

Textual Amendments

F76Word in Sch. 7 para. 12(a) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(a) and word in Sch. 7 para. 12(a) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(a)

F81Sch. 7 para. 12(c) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(b) and Sch. 7 para. 12(c) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(b)

[F8412A.—(1) In Northern Ireland, the qualified person is responsible for securing—U.K.

(a)that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(b)in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—

(i)a full qualitative analysis,

(ii)a quantitative analysis of all the active substances, and

(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and

(c)in the case of medicinal products, other than radiopharmaceuticals, that are required to bear safety features pursuant to Article 54a of the 2001 Directive and not intended to be exported to a country other than an EEA State, that the features specified in paragraph 18A of Schedule 24 have been affixed on the packaging.]

[F85(2) This paragraph does not apply in relation to listed NIMAR products in Northern Ireland.]

Textual Amendments

13.—(1) This paragraph applies [F86in Northern Ireland] where—U.K.

(a)a medicinal product which has undergone the controls referred to in [F87paragraph 12A in a member State is imported to Northern Ireland]; and

(b)each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph [F8812A].

Textual Amendments

14.—(1) This paragraph applies where—U.K.

(a)medicinal products are imported [F89into Great Britain from a country other than an approved country for import or into Northern Ireland] from a country other than an EEA State; and

[F90(b)appropriate arrangements have been made, in the case of import into Great Britain by the licensing authority with the country from which those products are imported and, in the case of a product for import into Northern Ireland by the European Union with that country, to ensure that—

(i)the manufacturer of the medicinal products applies standards of good manufacturing practice at least equivalent to those laid down—

(aa)in the case of a product for sale or supply in Great Britain, in the Good Manufacturing Practice Directive, as supplemented by the guidelines and principles which apply under, or by virtue of, regulation C17, and

(bb)in the case of a product for sale or supply in Northern Ireland, by the European Union;

(ii)the controls referred to in paragraph 12(b) or 12A(b) (as appropriate) have been carried out in that country.]

(2) Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph 12 [F91or 12A].

[F92(3) The licensing authority must publish a list of the countries with whom it has made appropriate arrangements under sub-paragraph (1)(b) (“approved country for batch testing list”).

(4) A country may be included in the approved country for batch testing list subject to any condition or restriction that the licensing authority considers appropriate, including as to categories of medicinal product, and any such condition or restriction must be included in the list.

(5) In order to satisfy itself of the matters specified in sub-paragraph (1)(b)(i) and (ii), the licensing authority may, in particular, take into account—

(a)the country's rules for good manufacturing practice;

(b)the regularity of inspections to verify compliance with good manufacturing practice;

(c)the effectiveness of enforcement of good manufacturing practice;

(d)the regularity and rapidity of information provided by that country relating to non-compliant manufacturers;

(e)any on-site review of that country's regulatory system undertaken by the licensing authority;

(f)any on-site inspection of a manufacturing site in that country observed by the licensing authority;

(g)any other relevant documentation available to the licensing authority.

(6) The licensing authority must—

(a)review any appropriate arrangements it has made under sub-paragraph (1)(b) to determine if that country still satisfies the requirements of sub-paragraph (1)(b)(i) and (ii), and whether any condition or restriction in those arrangements remains appropriate;

(b)if it is not so satisfied, remove that country from the approved country for batch testing list or, as the case may be, amend or remove that condition or restriction; and

(c)undertake such a review at least every three years beginning with the date on which the country is included in that list.]

Textual Amendments

15.—(1) The qualified person is responsible for ensuring, in relation to a medicinal product, that documentary evidence is produced that each batch of the product satisfies the requirements of paragraph 12.U.K.

(2) The documentary evidence referred to in sub-paragraph (1) must be kept up to date and must be available for inspection by the licensing authority for a period of at least five years.

Regulation 45N(5)(b)

[F93SCHEDULE 7AU.K.Information to be provided for registration as an importer, manufacturer or distributor of active substances

Textual Amendments

1.  The name and address of the applicant.U.K.

2.  The name and address of the person (if any) making the application on the applicant’s behalf.U.K.

3.  The address of each of the premises where any operations to which the registration relates are to be carried out.U.K.

4.  The address of any premises not mentioned by virtue of the above requirement, where—U.K.

(a)the applicant proposes to keep any living animals, from which substance(s) used in the production of the active substance(s) to which the application relates are to be derived;

(b)materials of animal origin from which an active substance is to be derived, as mentioned in the above sub-paragraph, are to be kept.

5.  The address of each of the premises where active substances are to be stored, or from which active substances are to be distributed.U.K.

6.  The address of each of the premises where any testing associated with the manufacture or assembly of active substances to which the registration relates.U.K.

7.  The name, address, qualifications and experience of the person whose duty it will be to supervise any manufacturing operations, and the name and job title of the person to whom they report.U.K.

8.  The name, address, qualifications and experience of the person who will have responsibility for the quality control of active substances, and the name and job title of the person to whom they report.U.K.

9.  The name, address, qualifications and experience of the person whose duty it will be to supervise any importation, storage or distribution operations, and the name and job title of the person to whom they report.U.K.

10.  The name, address and qualifications of the person to be responsible for any animals kept as mentioned in paragraph 4(a).U.K.

11.  The name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of an active substance.U.K.

12.  For each active substance to be manufactured, imported, or distributed—U.K.

(a)the CAS registration number assigned to that active substance by the Chemical Abstracts Service, a division of the American Chemical Society;

(b)where applicable, the Anatomical Therapeutic Category code assigned to that active substance under the Anatomical Therapeutic Chemical Classification System used for the classification of drugs by the World Health Organisation’s Collaborating Centre for Drug Statistics Methodology;

(c)either—

(i)the International Union of Pure and Applied Chemistry nomenclature, or

(ii)the common name; and

(d)the intended quantities of each active substance to be manufactured, imported or distributed.

13.  Details of the operations to which the registration relates, including a statement of whether they include—U.K.

(a)the manufacture of active substances;

(b)the importation of active substances F94...;

(c)the storage of active substances; or

(d)the distribution of active substances.

Textual Amendments

14.  A statement of the facilities and equipment available at each of the premises where active substances are to be manufactured, stored or distributed.U.K.

15.  A statement as to whether the particular active substances are intended for—U.K.

(a)use in a medicinal product with an EU marketing authorisation;

(b)use in a special medicinal product; or

(c)export F95....

Textual Amendments

16.  A separate statement in respect of each of the premises mentioned in the application of—U.K.

(a)the manufacturing, storage or distribution operations carried out at those sites, and the specific active substances to which those activities relate; and

(b)the equipment available at those premises for carrying out those activities.

17.  A statement of the authority conferred on the person responsible for quality control to reject unsatisfactory active substances.U.K.

18.  A description of the arrangements for the identification and storage of materials before and during the manufacture of active substances.U.K.

19.  A description of the arrangements for the identification and storage of active substances.U.K.

20.  A description of the arrangements at each of the premises where the applicant proposes to store active substances for ensuring, as far as practicable, the turn-over of stocks of active substances.U.K.

21.  A description of the arrangements for maintaining—U.K.

(a)production records, including records of manufacture and assembly;

(b)records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials use in manufacture, or of active substances, with the specification for such materials or active substances;

(c)records of importation;

(d)records of storage and distribution.

22.  A description of the arrangements for keeping reference samples of—U.K.

(a)materials used in the manufacture of active substances; and

(b)active substances.

23.  Where the application relates to active substances intended for use in an advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow traceability containing sufficient detail to enable the linking of an active substance to the advanced therapy medicinal product it was used in the manufacture of and vice versa.U.K.

24.  Details of—U.K.

(a)any manufacturing, importation, storage or distribution operations, other than those to which the application for registration relates, carried on by the applicant on or near each of the premises, and

(b)the substances or articles to which those operations relate.]

Regulation 50(1)

SCHEDULE 8U.K.Material to accompany an application for a UK marketing authorisation

PART 1U.K.General requirements

1.  The name or corporate name and permanent address of the applicant and (where applicable) of the manufacturer of the medicinal product.U.K.

2.  The name of the medicinal product. This may be—U.K.

(a)an invented name that is not liable to confusion with the product's common name; or

(b)a common or scientific name accompanied by a trademark or by the name of the person who is to be the marketing authorisation holder.

3.  Qualitative and quantitative particulars of the constituents of the medicinal product, including—U.K.

(a)where there is an international non-proprietary name recommended by the World Health Organisation for a constituent, a reference to that name; or

(b)otherwise, a reference to the relevant chemical name.

4.  An evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.U.K.

5.  A description of the methods of manufacturing the medicinal product.U.K.

6.  The therapeutic indications and contra-indications for the medicinal product and the adverse reactions associated with it.U.K.

7.  The posology and pharmaceutical form of the medicinal product, its method and route of administration and its expected shelf life.U.K.

8.  The reasons for any precautionary and safety measures to be taken for—U.K.

(a)the storage of the medicinal product;

(b)the administration of the medicinal product to patients; and

(c)the disposal of the medicinal product and any waste products,

with an indication of the potential risks presented by the medicinal product for the environment.

9.  A description of the control methods employed by the manufacturer.U.K.

[F969A.  A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing—U.K.

(a)information about the date of the audit; and

(b)a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.]

Textual Amendments

10.  The results of the following in relation to the medicinal product and its constituent active substances—U.K.

(a)pharmaceutical (physico-chemical, biological or microbiological) tests;

(b)pre-clinical (toxicological and pharmacological) tests; and

(c)clinical trials.

11.  A detailed summary of those results prepared and signed by an expert with appropriate technical or professional qualifications, which must be set out in a brief curriculum vitae.U.K.

12.  A summary of the applicant's pharmacovigilance system which shall include the following elements—U.K.

(a)proof that the applicant has at the applicant's disposal an appropriately qualified person responsible for pharmacovigilance [F97who is ordinarily resident, and operates, in the United Kingdom or a member State];

[F98(b)the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;]

(c)the contact details of the appropriately qualified person;

(d)a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

[F99(e)a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.]

Textual Amendments

13.  The risk management plan, together with a summary, that—U.K.

(a)describes the risk management system which the applicant will introduce for the medicinal product concerned; and

(b)shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

14.  Where any clinical trials have been carried out outside the European Union, a statement to the effect that the trials met the ethical requirements of the Clinical Trials Directive.U.K.

15.  A summary of the product characteristics for the medicinal product in accordance with Part 2 of this Schedule.U.K.

16.  A mock-up, in accordance with Part 13 (packaging and leaflets) of—U.K.

(a)the outer packaging of the medicinal product;

(b)the immediate packaging of the medicinal product; and

(c)the package leaflet for the medicinal product.

17.  A document showing that the manufacturer of the medicinal product is authorised to produce medicinal products in the manufacturer's own country.U.K.

[F10018.   Where—U.K.

(a)in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—

(i)a list of the member State or States concerned, and

(ii)in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;

(b)in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.]

Textual Amendments

19.  Where an authorisation for the medicinal product to be placed on the market has been granted by [F101, in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission]—U.K.

(a)a copy of that authorisation;

(b)a summary of the safety data, including the data contained in the periodic safety update reports, where available; and

(c)any suspected adverse reaction reports.

Textual Amendments

20.  Where [F102, in the case of a medicinal product for sale or supply in Northern Ireland,] an authorisation for the medicinal product to be placed on the market has been granted by a member State in accordance with the 2001 Directive, a copy of—U.K.

(a)the summary of the product characteristics approved by the competent authority of the member State; and

(b)the package leaflet approved by that competent authority.

Textual Amendments

[F10321.  Where an authorisation for the medicinal product to be placed on the market has been refused—U.K.

(a)in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b)in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.]

Textual Amendments

22.  [F104 In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any] designation of the medicinal product as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products M3 together with a copy of the relevant Agency opinion.

Textual Amendments

Marginal Citations

M3OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.

PART 2U.K.Summary of the product characteristics

The summary of the product characteristics must contain the following information in the following order—

[F10523.  For medicinal products included on the list referred to—U.K.

(a)in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b)in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.]

Textual Amendments

24.  The name of the medicinal product followed by its strength and pharmaceutical form.U.K.

25.  The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of—U.K.

(a)the active substances; and

(b)those excipients of which knowledge is essential for proper administration of the medicinal product.

[F10625A.  In the case of an advanced therapy medicinal product for sale or supply in Great Britain which contains cells or tissues, a detailed description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.]U.K.

Textual Amendments

26.  The pharmaceutical form of the medicinal product.U.K.

27.  Clinical particulars in relation to the medicinal product, covering—U.K.

(a)therapeutic indications;

(b)posology and method of administration for adults and, where necessary, for children;

therapeutic indications;

(c)contra-indications;

(d)special warnings and precautions for use and, in the case of immunological medicinal products any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient;

(e)interaction with other medicinal products and other forms of interactions;

(f)use during pregnancy and lactation;

(g)effects on ability to drive and to use machines;

(h)other undesirable effects; and

(i)information on overdose (including symptoms, emergency procedures and antidotes).

28.  The pharmacological properties of the medicinal product, covering—U.K.

(a)pharmacodynamic properties;

(b)pharmacokinetic properties; and

(c)pre-clinical safety data.

29.  Pharmaceutical particulars in relation to the medicinal product, covering—U.K.

(a)a list of excipients;

(b)major incompatibilities;

(c)shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d)special precautions for storage;

(e)nature and contents of container; and

(f)special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

30.  The holder of the UK marketing authorisation.U.K.

31.  The number of the UK marketing authorisation.U.K.

32.  The date of the first UK marketing authorisation or, where the UK marketing authorisation has been renewed, the date of the last renewal.U.K.

33.  The date of any revisions of the text of the summary of the product characteristics.U.K.

34.  For radiopharmaceuticals, full details of internal radiation dosimetry.U.K.

35.  For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.U.K.

[F10736.  In the case of an advanced therapy medicinal product for sale or supply in Great Britain—U.K.

(a)references in this Part of this Schedule to administration of a product include references to the advanced therapy medicinal product's use, application or implantation; and

(b)descriptions, instructions and warnings must include explanatory drawings and pictures where necessary.]

Textual Amendments

Regulation 50(1A)

[F108SCHEDULE 8AU.K.Material to accompany an application for a parallel import licence

Textual Amendments

1.  The name or corporate name and permanent address of the applicant.U.K.

2.  The name of the medicinal product. This may be—U.K.

(a)an invented name that is not liable to confusion with the product’s common name; or

(b)a common or scientific name accompanied by a trademark or by the name of the person who is to be the parallel import licence holder.

3.  Details of the product to be imported if requested by the licensing authority.U.K.

4.  Details of the UK reference product.U.K.

5.  If requested by the licensing authority, an evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.U.K.

6.  If requested by the licensing authority, a summary of the applicant’s pharmacovigilance system which shall include the following elements—U.K.

(a)proof that the applicant has at the applicant’s disposal an appropriately qualified person responsible for pharmacovigilance [F109who resides and operates in the United Kingdom];

F110(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)the contact details of the appropriately qualified person;

(d)a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

(e)a reference to the location where the pharmacovigilance system master file for the medicinal product is kept [F111or, if kept in electronic form, from which it can be accessed, which in either case, must be in the United Kingdom].

Textual Amendments

7.  If requested by the licensing authority, the risk management plan, together with a summary, that—U.K.

(a)describes the risk management system which the applicant will introduce for the medicinal product concerned; and

(b)shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

8.  If requested by the licensing authority, a summary of the product characteristics for the medicinal product in accordance with Part 2 of Schedule 8.U.K.

9.  A mock-up, in accordance with Part 13 (packaging and leaflets) of—U.K.

(a)the outer packaging of the medicinal product;

(b)the immediate packaging of the medicinal product; and

(c)the package leaflet for the medicinal product.]

Regulation 8(1)

[F112SCHEDULE 8BU.K.Modifications of Annex I to the 2001 Directive

Textual Amendments

Provision of Annex IModification subject to which that provision is to be read
Paragraph (1) of the Introduction and general principlesThe reference to “Articles 8 and 10(1)” is to be read as a reference to regulation 50 of the Human Medicines Regulations 2012.
Paragraphs (1) and (2) of the Introduction and general principlesIf the licensing authority has published guidelines under regulation 50(5B)(a) of the Human Medicines Regulations 2012, the reference to “the rules governing medicinal products in the European Community, Volume 2B, Notice to applicants, medicinal products for human use, presentation and content of the dossier, Common Technical Document” is to be read as a reference to that guidance.
Paragraph (4) of the Introduction and general principlesIf the licensing authority has published guidelines under regulation 50(5B)(b) of the Human Medicines Regulations 2012, the reference to “the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and the European Medicines Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of the rules governing medicinal products in the European Community” is to be read as a reference to those guidelines.
Paragraph (6) of the Introduction and general principlesThe reference to “the requirements of Commission Directive 91/356/EEC laying down the principles of and guidelines of Good Manufacturing Practice for medicinal products for human use” is to be read as a reference to the Good Manufacturing Practice Directive, as defined in regulation 8(1) of the Human Medicines Regulations 2012.
Paragraph (6) of the Introduction and general principlesIf the licensing authority has published principles and guidelines under regulation C17(1) of the Human Medicines Regulations 2012, the reference to “the principles and guidelines on GMP published by the Commission in the rules governing medicinal products in the European Community, Volume 4” is to be read as a reference to those principles and guidelines.
Paragraph (8) of the Introduction and general principlesReferences to “the European Community” are to be read as references to the United Kingdom.
Paragraph (8) of the Introduction and general principlesThe references to “Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” are to be read as references to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004.
Paragraph (9) of the Introduction and general principlesThe reference to “Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances and 88/320/EEC on the inspection and verification of good laboratory practice” is to be read as a reference to the Good Laboratory Practice Regulations 1999.
Paragraph (10) of the Introduction and general principlesThe reference to “Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes” is to be read as a reference to the Animals (Scientific Procedures) Act 1986.
Paragraph (11) of the Introduction and general principlesThe paragraph is to be read as follows: “In order to monitor the benefit/risk assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the licensing authority. After a marketing authorisation has been granted, any change to the data in the dossier shall be submitted to the licensing authority in accordance with the requirements of Schedule 10A to the Human Medicines Regulations 2012, as well as the requirements of Schedule 12A to those Regulations.”
Part I, paragraph 1.2, fourth paragraphThis paragraph is to be read as follows: “Annexed to the administrative data shall be copies of the manufacturing authorisation as defined in regulation 17 of the Human Medicines Regulations 2012.”
Part I, paragraph 1.3.1The reference to “Article 11” is to be read as a reference to Part 2 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 1.3.2The reference to “Title V” is to be read as a reference to Part I3 of the Human Medicines Regulations 2012, and the references to Articles 63 and 59 are to be read as references to regulations 260 and 266 of the Human Medicines Regulations 2012.
Part I, paragraph 1.3.4This paragraph is to be read as omitted.
Part I, paragraph 1.4The reference to “Article 12.2” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 2, first paragraphThe reference to “Article 12” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 3.2(5), first paragraphThe reference to a “Member State” is to be read as including the United Kingdom.
Part I, paragraph 3.2(5), second paragraphThe references to “the national pharmacopoeia of a Member State” are to be read as including references to the British Pharmacopoeia.
Part I, paragraph 3.2(6)The reference to “the pharmacopoeia of a Member State” is to be read as including a reference to the British Pharmacopoeia.
Part I, paragraph 3.2(12)The words “which is required by Community legislation” are to be read as omitted.
Part I, paragraph 3.2.1.2If the licensing authority has published guidelines under regulation 50(5B)(c) of the Human Medicines Regulations 2012, the reference to “guidelines published by the Agency” is to be read as a reference to those guidelines.
Part I, paragraph 3.2.2.1, second paragraphThe reference to “Article 8(3)(c)” is to be read as a reference to paragraph 3 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 3.2.2.1, second paragraph, first indentThe reference to “the national pharmacopoeia of one of the Member States” is to be read as including the British Pharmacopoeia.
Part I, paragraph 3.2.2.1, fifth paragraphThe reference to “any Member State” is to be read as a reference to the United Kingdom and the reference to “the Member States” is to be read as a reference to the United Kingdom.
Part I, paragraph 3.2.2.3(a)The reference to “Article 8(3)(d)” is to be read as a reference to paragraph 5 of Schedule 8 to the Human Medicines Regulations 2012.
Part I, paragraph 4.2.2, fifth paragraphThe reference to “this Directive” is to be read as a reference to the Human Medicines Regulations 2012.
Part I, paragraph 5.2(a)The reference to “the clinical particulars provided pursuant to Articles 8(3)(i) and 10(1)” is to be read as a reference to those particulars provided pursuant to paragraph 10 of Schedule 8 to, and regulations 51A, 52A, 53A and 54 to 56 of, the Human Medicines Regulations 2012.
Part I, paragraph 5.2(c)The references to “the European Community” are to be read as references to the United Kingdom.
Part I, paragraph 5.2(c), fifth paragraphThe reference to “Directive 2001/20/EC and implementing detail guidelines” is to be read as a reference to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004.
Part I, paragraph 5.2.1, second paragraphThe reference to “Article 10(1)(a)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012.
Part II, paragraph 1, first paragraphThe reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012.
Part II, paragraph 2(a)The reference to “Article 10(1)(a)(i)” is to be read as a reference to regulation 56 of the Human Medicines Regulations 2012.
Part II, paragraph 2(b)The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012.
Part II, paragraph 4, first paragraphThe first sentence is to be read as omitted and the words “in accordance with regulation 53A of the Human Medicines Regulations 2012” are to be read as added at the end of the second sentence.
Part II, paragraph 5, first paragraphThe reference to “Article 10(1)(b)” is to be read as a reference to regulation 55 of the Human Medicines Regulations 2012.
Part II, paragraph 6, first paragraphThe reference to “Article 22” is to be read as a reference to regulation 60 of the Human Medicines Regulations 2012.
Part III, paragraph 1.1(a), first indentThe reference to “Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or blood plasma” is to be read as a reference to the Medical Devices Regulations 2002.
Part III, paragraph 1.1(a), third indentThe reference to “the Agency or the competent authority” is to be read as a reference to the licensing authority.
Part III, paragraph 1.1(a), fourth indentThis indent is to be read as omitted.
Part III, paragraph 1.1(b)The reference to “Article 109, as amended by Directive 2002/98/EC” is to be read as a reference to the Blood Safety and Quality Regulations 2005.
Part III, paragraph 1.1(b)(3), second paragraphThe reference to “medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” is to be read as a reference to investigational medicinal products.
Part III, paragraph 1.1.(c), second indentThis indent is to be read as follows: “The Plasma Master File is subject to a scientific and technical evaluation by the licensing authority.”
Part III, paragraph 1.1(c), fourth indentThis indent is to be read as follows: “Changes subsequently introduced to the terms of a Plasma Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.”
Part III, paragraph 1.1(c), final indentThis indent is to be read as omitted.
Part III, paragraph 1.2(c), first indentThe references to “a competent authority” and to “the Agency” are to be read as references to the licensing authority and the final two sentences are to be read as omitted.
Part III, paragraph 1.2(c), second indentThe reference to “the Community” is to be read as a reference to the United Kingdom.
Part III, paragraph 1.2(c), third indentThis indent is to be read as follows: “Changes in the content of a Vaccine Antigen Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.”
Part III, paragraph 1.2(c), fourth indentThis indent is to be read as omitted.
Part III, paragraph 1.2(c), fifth indentThis indent is to be read as omitted.
Part III, paragraph 2.1The reference to “applications based on Articles 6(2) and 9” is to be read as a reference to applications in relation to radionuclide generators, radionuclide kits, radionuclide precursors and radiopharmaceuticals.
Part III, paragraph 2.2, fourth paragraphThe reference to “Council Directives 87/18/EEC and 88/320/EEC” is to be read as a reference to the Good Laboratory Practice Regulations 1999.
Part III, paragraph 3, second paragraphThe reference to “Article 15” is to be read as a reference to regulation 103 of the Human Medicines Regulations 2012, the reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012 and the words “referred to in Article 16(1)” are to be read as “which are not registerable homoeopathic medicinal products”.
Part III, paragraph 3(a)The reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia and any pharmacopoeia used officially in a country that is included in a list published by the licensing authority for that purpose, and the reference to “the traditional names used in each Member State” is to be read as including the traditional name used in the United Kingdom.
Part III, paragraph 3(b), final paragraphThe reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia.
Part III, paragraph 3, penultimate paragraphThe reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012.
Part III, paragraph 5, first indentThe reference to “an orphan medicinal product in the meaning of Regulation (EC) No 141/2000” is to be read as a reference to a medicinal product to which the orphan criteria are claimed to apply.
Part III, paragraph 5, second indentThe reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012 and the reference to “Article 5” is to be read as a reference to regulation 167 of the Human Medicines Regulations 2012.
Part IV, paragraph 1, first paragraphThe reference to “point (a) of Article 2(1) of Regulation (EC) No 1394/2007” is to be read as a reference to regulation 2A of the Human Medicines Regulations 2012.
Part IV, paragraph 2This paragraph is to be read as omitted.
Part IV, paragraph 3.1, second paragraphThe reference to “Directive 2004/23/EC” is to be read as a reference to the Human Fertilisation and Embryology Act 1990and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the reference to “Directive 2002/98/EC” is to be read as a reference to the Blood Safety and Quality Regulations 2005.
Part IV, paragraph 3.3.2.1(a)The reference to “Directive 2004/23/EC” is to be read as a reference to the Human Fertilisation and Embryology Act 1990 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Part IV, paragraph 3.4.1, headingThe reference to “devices as referred to in Article 7 of Regulation (EC) No 1394/2007” is to be read as a reference to medical devices, bio-materials, scaffolds or matrices.
Part IV, paragraph 3.4.2, headingThe reference to “Article 2(1)(d) of Regulation (EC) No 1394/2007” is to be read as a reference to regulation 2A(10) of the Human Medicines Regulations 2012.
Part IV, paragraph 3.4.2(c)The reference to “Commission Directive 2003/32/EC” is to be read as a reference to the Medical Devices Regulations 2002.
Part IV, paragraph 3.4.2(d)The reference to “Directive 93/42/EEC or Directive 90/385/EEC” is to be read as a reference to the Medical Devices Regulations 2002.
Part IV, paragraph 3.4.2, final paragraphThe first sentence is to be read as follows: “The applicant shall make available on request of the licensing authority any information related to the assessment by the notified body which has carried out the assessment referred to in point (d) of this section.”]

Regulation 50(1)

[F113SCHEDULE 8CU.K.Material to accompany an application for a UK marketing authorisation under the unfettered access route

Textual Amendments

1.  A copy of the application submitted in connection with the granting of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.U.K.

2.  A copy of all material submitted in support of the application for the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.U.K.

3.  A copy of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.]U.K.

Regulation 50(4)

SCHEDULE 9U.K.Undertakings by non- [F114United Kingdom] manufacturers

Textual Amendments

1.  The manufacturer must provide and maintain such staff, premises and plant as are necessary for the carrying out in accordance with the [F115UK] marketing authorisation of such stages of the manufacture and assembly of the medicinal products to which the authorisation relates as are undertaken by the manufacturer.U.K.

Textual Amendments

2.  The manufacturer must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicinal products to which the [F115UK] marketing authorisation relates and which the manufacturer handles, stores or distributes as are necessary to avoid deterioration of the medicinal products.U.K.

Textual Amendments

3.  The manufacturer must provide and maintain a designated quality control department having authority in relation to quality control and being independent of all other departments.U.K.

4.  The manufacturer must conduct all manufacture and assembly operations in such a way as to ensure that the medicinal products to which the [F115UK] marketing authorisation relates conform with the standards of strength, quality and purity applicable to them under the [F115UK] marketing authorisation.U.K.

Textual Amendments

5.  The manufacturer must maintain an effective pharmaceutical quality assurance system involving the active participation of the management and personnel of the different services involved.U.K.

6.  Where animals are used in the production of any medicinal product and the [F115UK] marketing authorisation contains provisions relating to them the manufacturer must arrange for the animals to be housed in premises of such a nature and to be managed in such a way as will facilitate compliance with such provisions.U.K.

Textual Amendments

7.  The manufacturer must make such adequate and suitable arrangements as are necessary for carrying out in accordance with the [F115UK] marketing authorisation any tests of the strength, quality or purity of the medicinal products to which the [F115UK] marketing authorisation relates.U.K.

Textual Amendments

8.  The manufacturer must inform the holder of the [F115UK] marketing authorisation of any material alteration in the premises or plant used in connection with the manufacture or assembly of the medicinal products to which the [F115UK] marketing authorisation relates or in the operations for which such premises or plant are so used, and of any change since the granting of the relevant [F115UK] marketing authorisation in respect of any person—U.K.

(a)responsible for supervising the production operations;

(b)responsible for quality control of the medicinal products to which the [F115UK] marketing authorisation relates;

(c)in charge of the animals from which are derived any substance used in the production of the medicinal products to which the [F115UK] marketing authorisation relates; or

(d)responsible for the culture of any living tissues used in the manufacture of the medicinal products to which the [F115UK] marketing authorisation relates.

Textual Amendments

9.—(1) The manufacturer shall keep readily available for inspection by a person authorised by the licensing authority durable records of—U.K.

(a)the details of manufacture and assembly of each batch of the medicinal product to which the [F115UK] marketing authorisation relates; and

(b)the tests carried out on the product,

in such a form that the records will be easily identifiable from the number of the batch as shown on each container in which the medicinal product is exported from the country where it has been manufactured or assembled.

(2) The manufacturer shall permit the person authorised to take copies of or make extracts from such records.

(3) Such records shall not be destroyed for a period of five years from the date of release of the batch concerned, or one year after the expiry date of the batch, whichever is the later.

Textual Amendments

10.  The manufacturer must keep readily available for examination by a person authorised by the licensing authority samples of—U.K.

(a)each batch of finished products for at least a period of one year after their expiry date; and

(b)starting materials (other than solvents, gases or water) for at least a period of two years after release of the medicinal product of which those materials formed part,

except where the manufacturer is authorised by the licensing authority to destroy such samples earlier.

11.—(1) The manufacturer must implement a system for recording and reviewing complaints in relation to medicinal products to which a [F115UK] marketing authorisation relates, together with an effective system for recalling promptly and at any time the medicinal products in the distribution network.U.K.

(2) The manufacturer must record and investigate all complaints described in sub-paragraph (1) and must immediately inform the licensing authority of any defect which could result in a recall from sale, supply or export or in an abnormal restriction on such sale, supply or export.

Textual Amendments

12.  The manufacturer must inform the holder of the [F115UK] marketing authorisation of any material change since the day upon which the authorisation was granted in respect of—U.K.

(a)the facilities and equipment available at each of the premises of the manufacturer for carrying out any stage of the manufacture or assembly of the medicinal products to which the [F115UK] marketing authorisation relates;

(b)the facilities and equipment available at each of the premises of the manufacturer for the storage of the medicinal products to which the [F115UK] marketing authorisation relates on, and the distribution of the products from or between, such premises;

(c)any manufacturing operations, not being operations in relation to the medicinal products to which the [F115UK] marketing authorisation relates, which are carried on by the manufacturer on or near any of the premises on which medicinal products to which the [F115UK] marketing authorisation relates are manufactured or assembled, and the substances or articles in respect of which such operations are carried on;

(d)the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly of the medicinal products to which the [F115UK] marketing authorisation relates and the arrangements for the storage of the products after they have been manufactured or assembled;

(e)the arrangements for ensuring a satisfactory turnover of stocks of medicinal products to which the [F115UK] marketing authorisation relates;

(f)the arrangements for maintaining production records and records of analytical and other testing procedures applied in the course of manufacture or assembly of the medicinal products to which the [F115UK] marketing authorisation relates; or

(g)the arrangements for keeping reference samples of materials used in the manufacture of the medicinal products to which the [F115UK] marketing authorisation relates and reference samples of the medicinal products themselves.

Textual Amendments

Regulation 50G(4)

[F116SCHEDULE 9AU.K.Meaning of terms used in the orphan criteria and in regulation 58D

Textual Amendments

Prevalence of a condition in Great BritainU.K.

1.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(a) and (b)(i), that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in Great Britain.

(2) The material provided pursuant to regulation 50G(3) must include—

(a)material which demonstrates that the disease or condition for which the medicinal product would be authorised affects not more than five in 10,000 persons in Great Britain at the time at which the application for an orphan marketing authorisation is submitted, where this is available;

(b)details of the condition intended to be treated and a justification of the life-threatening or chronically debilitating nature of the condition, supported by scientific or medical references; and

(c)copies of, or references to, relevant scientific literature, as well as copies of information from relevant databases in Great Britain, where available.

(3) If there are no databases as referred to in paragraph (2)(c), information from relevant databases in other countries may be supplied, provided appropriate extrapolations are made.

Potential for return on investmentU.K.

2.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(a) and (b)(ii), that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition in Great Britain and that the medicinal product is unlikely, when marketed, to generate sufficient financial return to justify the necessary investment.

(2) The material provided pursuant to regulation 50G(3) must include—

(a)details of the condition intended to be treated and a justification of the life-threatening or chronically debilitating nature of the condition, supported by scientific or medical references;

(b)details of the costs incurred in connection with the development of the medicinal product;

(c)details of any grants, tax incentives or other cost recovery provisions received in Great Britain or any other country in relation to the development of the medicinal product;

(d)where the medicinal product is already authorised in Great Britain for any indication, or where the product is under investigation for one or more other indications, an explanation of, and justification for, the method that is used to apportion the development costs among the various indications;

(e)a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for a UK marketing authorisation;

(f)a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur in the first ten years that the medicinal product is authorised;

(g)an estimate of and justification for the expected revenues from sales of the medicinal product in Great Britain and elsewhere during the first ten years that the medicinal product is authorised; and

(h)information on the prevalence and incidence in Great Britain of the condition for which the medicinal product would be authorised at the time at which the application for an orphan marketing authorisation application is submitted.

(3) The information concerning costs and revenue referred to in sub-paragraph (2) must be determined in accordance with generally accepted accounting principles and must be certified by a person who is a member of a body of accountants which is established in the United Kingdom and which is approved by the licensing authority for the purposes of this paragraph.

Existence of other methods of diagnosis, prevention or treatmentU.K.

3.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(c), that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in Great Britain, or if such method exists, that the medicinal product will be of significant benefit to those affected by the condition.

(2) The material provided pursuant to regulation 50G(3) must include—

(a)details of any existing methods of diagnosis, prevention or treatment of the condition in question that have been authorised in Great Britain, making reference to scientific or medical literature or other relevant information, including information relating to authorised medicinal products, medical devices or other methods of diagnosis, prevention or treatment which are used in Great Britain; and

(b)a justification as to why either—

(i)the methods referred to in paragraph (a) are not considered satisfactory; or

(ii)the medicinal product for which an orphan marketing authorisation is sought will be of significant benefit to those affected by the condition.

(3) In this paragraph, “significant benefit” means a clinically relevant advantage or a major contribution to patient care.

Increased safety or effectiveness and clinical superiorityU.K.

4.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 58D(6)(c), that a second medicinal product is similar to a medicinal product to which an orphan marketing authorisation relates or is safer or more effective than, or clinically superior to, that product.

(2) The following definitions apply for the purposes of this paragraph—

“clinically superior”, in relation to a medicinal product, means that it is shown to provide a significant therapeutic or diagnostic advantage over and above that provided by an authorised orphan medicinal product in one or more of the following ways—

(a)

greater efficacy;

(b)

greater safety in a substantial portion of the target population, as evidenced where appropriate through comparative clinical trials; or

(c)

in exceptional cases, where neither greater safety nor greater efficacy has been shown, a demonstration that the medicinal product otherwise makes a major contribution to diagnosis or to patient care;

“similar active substance” means an identical active substance, or an active substance with the same principal molecular structural features, but not necessarily all of the same molecular structural features, and which acts via the same mechanism, however, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances is to be assessed on the basis of the biological and functional characteristics;

“similar medicinal product” means a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication.

(3) For the purposes of the definition of “clinically superior” in relation to a medicinal product which shows that superiority by means of greater efficacy, this is to be assessed by the effect on a clinically meaningful endpoint in adequate and well controlled clinical trials, representing the same kind of evidence needed to support a comparative efficacy claim for two different medicinal products.

(4) The clinical trials referred to in paragraph (3) should be direct comparative clinical trials, unless comparisons based on other endpoints, including surrogate endpoints, can be justified.

(5) Paragraphs 5 to 8 make further provision about the definition of “similar active substance” in relation to certain types of product.

5.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to chemical medicinal products.U.K.

(2) The principal molecular structural features are the relevant structural components of an active substance, which may be the whole or part of the molecule.

(3) Whether the principal molecular structural features are the same between two or more molecules will be identified by comparison of their structures.

(4) Isomers, mixtures of isomers, complexes, esters, ethers, salts and derivatives of the original active substance, or an active substance that differs from the original active substance only with respect to minor changes in the molecular structure, such as a structural analogue, are to be considered similar.

(5) Synthetic polynucleotide substances, single or double stranded, consisting of two or more distinct nucleotides where—

(a)the difference in the nucleotide sequence of the purine and pyrimidine bases or their derivatives is not major, are to be considered similar, therefore for antisense or interfering nucleotide substances, addition, substitution or deletion of a nucleotide not significantly affecting the kinetics of hybridisation to the target are usually to be considered similar; and

(b)the difference in structure related to modifications of the ribose or deoxyribose backbone sugars or to the replacement of the backbone sugars by synthetic analogues usually result in substances being considered similar, and for antisense or interfering nucleotide substances, changes in the ribose or deoxyribose backbone sugars not significantly affecting the kinetics of hybridisation to the target are usually to be considered similar.

6.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to biological medicinal products other than advanced therapy medicinal products.U.K.

(2) The principal molecular structural features are the structural components of an active substance that are relevant for the functional characteristics of that substance.

(3) The principal molecular structural features may be composed of a therapeutic moiety or a therapeutic moiety in combination with an additional structural element significantly contributing to the functional characteristics of the active substance.

(4) An additional structural element as described in paragraph (3) may be conjugated, fused or linked by other means to the therapeutic moiety or may be an extension of the therapeutic moiety protein backbone by additional amino acids.

(5) Substances with structural elements for which similar methods of modification or conjugation technology are used usually result in similar substances.

(6) Biological active substances which differ from the original biological substance only with respect to minor changes in the molecular structure are to be considered similar.

(7) In relation to proteinaceous substances—

(a)if the difference in structure between them is due to post-translational events, such as different glycosylation patterns, substances are usually to be considered similar; however, exceptionally some post-translational modifications may result in a non-similar substance if there is significant effect on the functional characteristics of the substance;

(b)if the difference in the amino acid sequence is not major, substances are usually to be considered similar; therefore two pharmacologically related protein substances of the same group, for example, having differences related to N-terminal methionine, naturally extracted as opposed to recombinant nucleic acid-derived proteins or other minor variants, are usually to be considered similar; however, the addition of a structural element may result in substances not being considered similar if this significantly affects the functional characteristics of the substance;

(c)monoclonal antibodies binding to the same target epitope are usually to be considered similar; however, two monocloncal antibody conjugates or fusion proteins may be considered not to be similar if either the Complementary Determining Region sequences of the antibody or the additional structural element of the conjugated monoclonal antibody is different.

(8) In relation to polysaccharide substances—

(a)if the substances have identical saccharide repeating units, even if the number of units varies, the substances are usually to be considered similar; and

(b)a conjugated polysaccharide vaccine compared to a non-conjugated polysaccharide vaccine containing the same antigen is considered not to be similar.

7.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to advanced therapy medicinal products.U.K.

(2) In relation to cell-based advanced therapy medicinal products, these are not to be considered similar if—

(a)there are differences in starting materials or the final composition of the product which have a significant impact on the biological characteristics or biological activity relevant for the intended therapeutic effect or safety attributes of the product, and the different source of the starting materials, such as in the case of autologous advanced therapy medicinal products, is not sufficient to support a claim that two products are not similar; or

(b)there are differences in the manufacturing technology having a significant impact on the biological characteristics or the biological activity relevant for the intended therapeutic effect or safety attributes of the product.

(3) In relation to gene therapy medicinal products—

(a)two gene therapy medicinal products are not to be considered similar when there are differences in the therapeutic sequence, viral vector, transfer system, regulatory sequences or manufacturing technology which significantly affect the biological characteristics or biological activity relevant for the intended therapeutic effect or safety attributes of the product; and

(b)differences in the therapeutic sequence with a significant impact on the intended therapeutic effect are not sufficient to support a claim that two gene therapy medicinal products are not similar.

(4) The considerations in paragraphs (2) and (3) also apply in relation to genetically modified cells.

8.—(1) This paragraph applies for the purposes of the definition of “similar active substance” in relation to radiopharmaceuticals.U.K.

(2) The same radiopharmaceutical active substance, or one differing from the original in radionuclide, ligand, site of labelling or molecule-radionuclide coupling mechanism linking the molecule and radionuclide which acts via the same mechanism, are to be considered similar substances.]

Regulations 50(6)(g) and 64(5)(b)

SCHEDULE 10U.K.National homoeopathic products

Meaning of “national homoeopathic product”U.K.

1.—(1) In this Schedule “national homoeopathic product” means a homoeopathic medicinal product that—U.K.

(a)is not a registrable homoeopathic medicinal product; and

(b)is indicated for the relief or treatment of minor symptoms or minor conditions in human beings.

(2) For this purpose symptoms or conditions are minor if they can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

General requirements for applicationU.K.

2.—(1) An application for the grant of a UK marketing authorisation for a national homoeopathic product does not need be made in accordance with, and an applicant for such an authorisation does not need to comply with—U.K.

(a)paragraphs (b) and (c) of paragraph 10 of Schedule 8 (requirement to submit results of pre-clinical tests and clinical trials);

(b)the guidance referred to in paragraph (1) in the “Introduction and general principles” of Annex 1 to the 2001 Directive in so far as it relates to the requirement to submit the results of pre-clinical tests and clinical trials; or

(c)the following provisions of Part 1 of that Annex—

(i)sections 2.4 to 2.7 (non-clinical and clinical overview and non-clinical and clinical summaries),

(ii)section 4 (Module 4: non-clinical reports), or

(iii)section 5 (Module 5: clinical study reports).

(2) The applicant must submit with the application—

(a)particulars and documents relating to the safety of the product in accordance with paragraph 3 (subject to paragraph 4); and

(b)particulars and documents relating to the efficacy of the product in accordance with paragraph 5.

(3) References in Annex 1 to the 2001 Directive to non-clinical reports, non-clinical documentation and non-clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 3.

(4) References in that Annex to clinical study reports, clinical documentation and clinical data apply in relation to the application as if they were references to the particulars and documents referred to in paragraph 5.

Requirement to submit safety dataU.K.

3.—(1) The applicant must submit data as to the safety of the product unless paragraph 4 applies.U.K.

(2) The data must include information about the following aspects of the safety of the product—

(a)pharmacology;

(b)pharmacokinetics; and

(c)toxicology, including its toxicity, genotoxicity, reproductive and developmental toxicity and local tolerance.

(3) The data must be scientific data unless sub-paragraph (5) applies.

(4) For this purpose “scientific data” means—

(a)study reports in relation to the product;

(b)published scientific data; or

(c)a combination of data within paragraph (a) and data within paragraph (b).

(5) The applicant may submit other data in relation to an aspect of the safety of the product if having made reasonable attempts to obtain scientific data in relation to that aspect—

(a)the applicant is satisfied that no such scientific data is available; or

(b)the applicant thinks that such scientific data as is available may be inadequate to demonstrate an acceptable level of safety in relation to that aspect.

(6) The applicant must include with the data—

(a)a table of contents; and

(b)an evaluation of the scientific data, including an explanation of how it demonstrates an acceptable level of safety.

(7) If the applicant submits data other than scientific data, the applicant must include—

(a)a statement that sub-paragraph (5) applies; and

(b)an explanation of why an acceptable level of safety can be demonstrated despite the lack of scientific data.

Exceptions to requirement to submit safety dataU.K.

4.—(1) The applicant does not need to submit data as to the safety of the product if—U.K.

(a)condition A, B or C is met; and

(b)the application is accompanied by a written statement that the condition is met.

(2) Condition A is that the product—

(a)is derived from a homoeopathic stock that is commonly present in food; and

(b)is intended to be administered orally.

(3) For this purpose “food” has the meaning given by Council Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety M4.

(4) Condition B is that—

(a)the product is derived from a homoeopathic stock from which is derived a medicinal product that has a [F117UK] marketing authorisation, certificate of registration or traditional herbal registration (“the source product”);

(b)the source product is subject to general sale within the meaning of regulation 5(1); and

(c)the product has the same route of administration and the same degree of dilution as the source product.

(5) Condition C is that the product is derived from a homoeopathic stock that—

(a)is diluted to at least 1 in 1024 of the stock; and

(b)is not a material derived from a human or animal source.

Textual Amendments

Marginal Citations

M4OJ No L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p. 14).

Requirement to submit efficacy dataU.K.

5.—(1) The applicant must submit data as to the efficacy of the product.U.K.

(2) The data must consist of at least one the following—

(a)study reports in relation to the product;

(b)published scientific literature; or

(c)the results of investigations (commonly known as homoeopathic provings) consisting of the administration of a substance to a human subject to ascertain the symptoms it produces.

(3) The applicant must include with the data—

(a)a table of contents; and

(b)an evaluation of the data, including an explanation of how the data establishes that the product has a recognised level of efficacy in the therapeutic indication for which authorisation is sought.

Regulation 65C(2)

[F118SCHEDULE 10AU.K.Variations to a UK marketing authorisation

Textual Amendments

InterpretationU.K.

1.  In this Schedule—

“change of, or addition of a new, route of administration”, in relation to parenteral administration, includes any change or addition as between intra-arterial, intra-venous, intramuscular, subcutaneous and any other route;

“extension of a UK marketing authorisation” or “extension” means a variation which consists of—

(a)

a change to one or more active substances that involves—

(i)

replacement of a chemical active substance by a different salt, ester, complex or derivative, with the same therapeutic moiety, where the efficacy and safety characteristics are not significantly different,

(ii)

replacement by a different isomer, a different mixture of isomers, of a mixture by an isolated isomer (for example, racemate by a single enantiomer), where the efficacy and safety characteristics are not significantly different,

(iii)

replacement of a biological active substance with one of a slightly different molecular structure where the efficacy and safety characteristics are not significantly different, with the exception of changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza,

(iv)

modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source, where the efficacy and safety characteristics are not significantly different,

(v)

a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy and safety characteristics are not significantly different, or

(vi)

change to the extraction solvent or the ratio of herbal drug to herbal drug preparation where the efficacy and safety characteristics are not significantly different; or

(b)

a change to strength, pharmaceutical form and route of administration that involves—

(i)

change of bioavailability,

(ii)

change of pharmacokinetics, for example change in rate of release,

(iii)

change or addition of a new strength or potency,

(iv)

change or addition of a new pharmaceutical form, or

(v)

change or addition of a new route of administration;

“holder” means UK marketing authorisation holder;

“major variation of type II” means a variation which is not an extension and which may have a significant impact on the quality, safety or efficacy of the medicinal product concerned namely—

(a)

variations related to the addition of a new therapeutic indication or to the modification of an existing one;

(b)

variations related to significant modifications of the summary of product characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance findings;

(c)

variations related to changes outside the range of approved specifications, limits or acceptance criteria;

(d)

variations related to substantial changes to the manufacturing process, formulation, specifications or impurity profile of the active substance or finished medicinal product which may have a significant impact on the quality, safety or efficacy of the medicinal product;

(e)

variations related to modifications in the manufacturing process or sites of the active substance for a biological medicinal product;

(f)

variations related to the introduction of a new design space or the extension of an approved one, where the design space has been developed in accordance with international scientific guidelines; or

(g)

variations related to changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;

“minor variation of type IA” means a variation which has only a minimal impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned namely—

(a)

variations of purely administrative nature that are related to the identity and contact details of—

(i)

the holder,

(ii)

the manufacturer or supplier of any starting material, reagent, intermediate, active substance used in the manufacturing process or finished product;

(b)

variations related to the identity, location and contact details of the qualified person for pharmacovigilance, or the location of the pharmacovigilance system master file;

(c)

variations related to the deletion of any manufacturing site, including for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place;

(d)

variations related to minor changes to an approved physico-chemical test procedure, where the updated procedure is demonstrated to be at least equivalent to the former test procedure, appropriate validation studies have been performed and the results show that the updated test procedure is at least equivalent to the former;

(e)

variations related to changes made to the specifications of the active substance or of an excipient in order to comply with an update of the relevant monograph of the European Pharmacopoeia or of the British Pharmacopoeia, where the change is made exclusively to comply with the pharmacopoeia and the specifications for product specific properties are unchanged;

(f)

variations related to changes in the packaging material not in contact with the finished product, which do not affect the delivery, use, safety or stability of the medicinal product;

(g)

variations related to the tightening of specification limits, where the change is not a consequence of any commitment from previous assessment to review specification limits and does not result from unexpected events arising during manufacture;

“minor variation of type IB” means a variation which is not a minor variation of type IA, a major variation of type II nor an extension; and

“urgent safety restriction” means an interim change in the terms of the UK marketing authorisation due to new information having a bearing on the safe use of the medicinal product.

Classification of variationsU.K.

2.—(1) Except where sub-paragraph (2) applies, a variation which is not an extension, and whose classification is undetermined after—

(a)application of the provisions in this Schedule; and

(b)taking into account—

(i)the guidance referred to in regulation 65C(4) or (6) as the case may be), and

(ii)where relevant, any recommendations delivered pursuant to paragraph 3,

is to be treated by the licensing authority as a minor variation of type IB.

(2) The licensing authority must treat a variation that would otherwise fall within sub-paragraph (1) as a major variation of type II in the following cases—

(a)upon request from the holder when submitting the variation; or

(b)where the licensing authority concludes, following the assessment of validity of a notification in accordance with paragraph 7(1), and taking into account the recommendations given under paragraph 3, that the variation may have a significant impact on the quality, safety or efficacy of the medicinal product concerned.

Licensing authority recommendation on unclassified variationsU.K.

3.—(1) Prior to the submission of a variation whose classification is not provided for in this Schedule—

(a)the holder may request a recommendation on the classification of the variation from the licensing authority; and

(b)the licensing authority must notify the holder of its recommendation within 45 days of that request, beginning with the date on which the request is received by the licensing authority.

(2) The 45-day period referred to in sub-paragraph (1)(b) may be extended by 25 days where the licensing authority deems it necessary.

Variations leading to the revision of product informationU.K.

4.  Where a variation leads to the revision of the summary of product characteristics, labelling or the package leaflet, the revision must be considered by the licensing authority as part of that variation.

Grouping of variationsU.K.

5.—(1) Except where sub-paragraph (2) applies, where several variations are notified or applied for, a separate notification or application in accordance with paragraph 6, 7, 8 or 11 of this Schedule is to be submitted in respect of each variation sought.

(2) This sub-paragraph applies—

(a)where one or more of the same minor variations of type IA to the terms of one or more UK marketing authorisations owned by the same holder are notified at the same time to the licensing authority, in which case a single notification as referred to in paragraph 6 may cover all such variations;

(b)where several variations to the terms of the same UK marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the relevant circumstances specified in sub-paragraph (3);

(c)where one or more of the same variation to the terms of one or more UK marketing authorisations held by the same holder are submitted at the same time and the variations do not fall within paragraph (a) or (b), a single submission may cover all such variations provided that the licensing authority agrees to such single submission.

(3) The relevant circumstances are—

(a)one of the variations in the group is an extension of the UK marketing authorisation;

(b)one of the variations in the group is a major variation of type II, but all other variations in the group are variations which are consequential to this major variation of type II;

(c)one of the variations in the group is a minor variation of type IB, but all other variations in the group are minor variations which are consequential to this minor variation of type IB;

(d)all variations in the group relate solely to changes of an administrative nature to the summary of product characteristics, labelling and package leaflet or insert;

(e)all variations in the group are changes to an Active Substance Master File, Vaccine Antigen Master File or Plasma Master File;

(f)all variations in the group relate to a project intended to improve the manufacturing process and the quality of the medicinal product concerned or one or more of its active substances;

(g)all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;

(h)all variations in the group are changes to the pharmacovigilance system referred to in paragraph 12 of Schedule 8;

(i)all variations in the group are consequential to a given urgent safety restriction and submitted in accordance with paragraph 14;

(j)all variations in the group relate to the implementation of a given class labelling;

(k)all variations in the group are consequential to the assessment of a given periodic safety update report;

(l)all variations in the group are consequential to a given post-authorisation study conducted under the supervision of the holder;

(m)all variations in the group are consequential to a condition imposed under regulation 59(4C) or (4D).

(4) The submission referred to in sub-paragraph (2)(b) and (c) must be made by means of the following—

(a)a single notification in accordance with paragraph 7 where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations;

(b)a single application in accordance with paragraph 8 where at least one of the variations is a major variation of type II and none of the variations is an extension; or

(c)a single application in accordance with paragraph 11 where at least one of the variations is an extension.

Notification procedure for minor variations of type IAU.K.

6.—(1) Subject to sub-paragraph (2), where a minor variation of type IA is made, the holder must submit to the licensing authority a notification containing the elements listed in paragraph 9 within 12 months, beginning with the date on which the variation is implemented by the holder.

(2) The notification referred to in sub-paragraph (1) must be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned.

(3) Within 30 days beginning with the date on which the licensing authority receives a notification under this paragraph, the measures provided for in paragraph 10 are to be taken.

Notification procedure for minor variations of type IBU.K.

7.—(1) The holder must for minor variations of type IB submit to the licensing authority a notification containing the elements listed in paragraph 9, and if the notification contains those elements, the licensing authority must acknowledge receipt of a valid notification.

(2) If within 30 days beginning with the date on which the licensing authority acknowledges receipt of a valid notification, the licensing authority has not sent the holder an unfavourable opinion, the notification is deemed to be accepted by the licensing authority.

(3) Where the notification is accepted by the licensing authority, the measures provided for in paragraph 10 are to be taken.

(4) Where the licensing authority is of the opinion that the notification cannot be accepted, it must inform the holder, stating the grounds on which its unfavourable opinion is based.

(5) Within 30 days beginning with the date on which the holder receives the unfavourable opinion, the holder may submit to the licensing authority an amended notification in order to take due account of the grounds laid down in that opinion.

(6) If the holder does not amend the notification in accordance with sub-paragraph (5), the notification is deemed to be rejected.

(7) Where an amended notification has been submitted, the licensing authority must assess it within 30 days beginning with the date on which it receives the amended notification, and the measures provided for in paragraph 10 are to be taken.

(8) This paragraph does not apply where—

(a)a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension: in such a case, the prior approval procedure in paragraph 8 applies; or

(b)a type IB variation request is submitted in a grouping that includes an extension: in such a case, the procedure in paragraph 11 applies.

Prior approval procedure for major variations of type IIU.K.

8.—(1) The holder must submit to the licensing authority an application containing the elements listed in paragraph 9, and if the application contains those elements, the licensing authority must acknowledge receipt of a valid application.

(2) Subject to sub-paragraph (3), within 60 days beginning with the date on which the licensing authority acknowledges receipt of a valid application under sub-paragraph (1), the licensing authority must conclude the assessment.

(3) The licensing authority may—

(a)reduce the period referred to in sub-paragraph (2), having regard to the urgency of the matter; or

(b)extend it to 90 days for—

(i)variations concerning a change to, or addition of, therapeutic indications, or

(ii)grouping of variations in accordance with paragraph 5(2)(c).

(4) Within the periods referred to in sub-paragraph (2) or (3), the licensing authority may request the holder to provide supplementary information within a time limit that it specifies, in which case—

(a)the procedure is suspended from the date on which such a request is made until the date on which that supplementary information has been provided; and

(b)the licensing authority may extend the period referred to in sub-paragraph (2) by the period for which the procedure is so suspended.

(5) Within 30 days beginning with the date on which the licensing authority concludes its assessment of the application, the measures provided for in paragraph 10 are to be taken.

(6) This paragraph does not apply where a type II variation request is submitted in a grouping that includes an extension: in such case, the procedure in paragraph 11 applies.

Elements to be submittedU.K.

9.  An application or notification under this Schedule must include—

(a)a list of all the UK marketing authorisations affected by the notification or application;

(b)a description of all the variations submitted, including—

(i)in the case of minor variations of type IA, the date of implementation for each variation described,

(ii)in the case of minor variations of type IA which do not require immediate notification, a description of all minor variations of type IA made in the last 12 months to the terms of any affected UK marketing authorisation, such period beginning with the day on which the application or notification is submitted, and which have not been already notified,

(iii)any documents specified in guidance published under regulation 65C(4) or (6) (as the case may be), insofar as relevant to the type of variation notified or applied for,

(iv)where a variation leads to or is the consequence of other variations to the terms of the same UK marketing authorisation, a description of the relationship between those variations, and

(v)the relevant fee provided for in the Fees Regulations.

Measures to close the procedures specified in paragraphs 6 to 8U.K.

10.  Where reference is made to this paragraph, the licensing authority must take the following measures—

(a)inform the holder as to whether the variation is accepted or rejected;

(b)where the variation is rejected, inform the holder of the grounds for the rejection; and

(c)where necessary, amend the decision granting the UK marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 15.

Extensions of marketing authorisationsU.K.

11.—(1) An application for an extension of a UK marketing authorisation must be assessed by the licensing authority in accordance with the same or equivalent procedure that applied under Part 5 to the initial UK marketing authorisation to which it relates.

(2) An extension must either be granted a UK marketing authorisation in accordance with the same or equivalent procedure as for the granting of the initial UK marketing authorisation to which it relates, or be included in that initial UK marketing authorisation.

Human influenza vaccinesU.K.

12.—(1) By way of exception from paragraph 8, the procedure laid down in sub-paragraphs (2) to (4) applies to the examination of variations concerning changes to the active substance for the purposes of the annual update of a human influenza vaccine.

(2) The holder must submit to the licensing authority an application containing the elements listed in paragraph 9, and if it does so, the licensing authority must acknowledge receipt of a valid application.

(3) The licensing authority must assess the application submitted, and where it deems it necessary, the licensing authority may request additional data from the holder in order to complete its assessment.

(4) The licensing authority must—

(a)adopt a decision within 45 days, beginning with the date on which it receives a valid application; and

(b)take the measures provided for in paragraph 10.

(5) The 45-day period referred to in sub-paragraph (4) is to be suspended from the date on which the additional data referred to in sub-paragraph (3) is requested until the date on which that data is received by the licensing authority.

Pandemic situation with respect to human influenzaU.K.

13.—(1) By way of exception to the provisions of this Schedule, where a pandemic situation with respect to human influenza is duly recognised by the World Health Organisation, or the licensing authority, the licensing authority may exceptionally and temporarily accept a variation to the terms of a UK marketing authorisation for a human influenza vaccine, where certain non-clinical or clinical data are missing.

(2) Where a variation is accepted pursuant to sub-paragraph (1), the holder must submit the missing non-clinical and clinical data within a time limit set by the licensing authority.

Urgent safety restrictionsU.K.

14.—(1) Where, in the event of a risk to public health, the holder takes urgent safety restrictions on its own initiative, it must forthwith notify the licensing authority.

(2) If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted.

(3) In the event of a risk to public health in relation to a medicinal product, the licensing authority may impose urgent safety restrictions on the holder of the UK marketing authorisation in respect of that product.

(4) Where an urgent safety restriction is taken by the holder, or imposed by the licensing authority, the holder must submit the corresponding application for variation within 15 days beginning with the date on which that restriction is initiated.

Amendments to the decision granting the marketing authorisationU.K.

15.—(1) Amendments to the decision granting the UK marketing authorisation resulting from the procedures laid down in this Schedule must be made by the licensing authority—

(a)in the case of major variations of type II, within two months, beginning with the date on which the information referred to in paragraph 10(a) is sent to the holder; or

(b)in the other cases, within six months, beginning with the date on which the information referred to in paragraph 10(a) is sent to the holder,

and the licensing authority must notify the holder of the amended decision without delay.

(2) The statement indicating compliance with the agreed completed paediatric investigation plan provided for under regulation 58A(2)(a) must be included within the technical dossier of the UK marketing authorisation, and the licensing authority must confirm to the holder that it is so included when it notifies the holder under paragraph 10(a).

Implementation of variationsU.K.

16.—(1) Minor variations of type IA may be implemented any time before completion of the procedures laid down in paragraph 6.

(2) Where a notification concerning one or several minor variations of type IA is rejected, the holder must cease to apply the rejected variation immediately after receipt of the information referred to in paragraph 10(a).

(3) Minor variations of type IB may only be implemented after the licensing authority has informed the holder that it has accepted the notification pursuant to paragraph 7, or after the notification is deemed accepted pursuant to paragraph 7(2).

(4) Major variations of type II may only be implemented after the licensing authority has informed the holder that it has accepted the variation pursuant to paragraph 10.

(5) An extension may only be implemented after the licensing authority has amended the decision granting the marketing authorisation and notified the holder accordingly.

(6) Urgent safety restrictions, and variations which are related to safety issues, must be implemented within a time frame agreed by the holder and the licensing authority.

Continuous monitoringU.K.

17.  Where requested to do so by the licensing authority, the holder must supply to the licensing authority without delay any information related to the implementation of a given variation.]

Regulations 58(5);59(7); 60(11);66(8); 68(12); 104(4);105(9); 108(8); 110(9);130(11); 133(8); and 137

SCHEDULE 11U.K.Advice and representations

PART 1U.K.General procedures

Application of this PartU.K.

1.—(1) This Part of this Schedule applies to—U.K.

(a)an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration;

(b)an application to renew a UK marketing authorisation, certificate of registration or traditional herbal registration; F119...

(c)a proposal to revoke, vary or suspend a UK marketing authorisation, certificate of registration or traditional herbal registration (including variation by the variation or removal of a condition to which a UK marketing authorisation or a certificate of registration is subject) other than a proposal to vary the authorisation, certificate or registration on the application of or by agreement with its holder [F120; and

(d)a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

[F121(1A) Paragraphs 12 and 13 of this Part also apply to—

(a)an application for the grant of a parallel import licence;

(b)an application to renew a parallel import licence;

(c)a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and

(d)a refusal to vary a parallel import licence following an application for a variation by the holder.]

[F122(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]

Textual Amendments

Requirement to consult the appropriate committeeU.K.

2.—(1) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety, quality or efficacy—U.K.

(a)to refuse to grant or renew a UK marketing authorisation or traditional herbal registration in response to the application; or

(b)to revoke, vary or suspend a UK marketing authorisation or traditional herbal registration.

(2) The licensing authority must consult the appropriate committee if the authority proposes on grounds relating to safety or quality—

(a)to refuse to grant or renew a certificate of registration in response to the application; or

(b)to revoke, vary or suspend a certificate of registration.

[F123(2A) The licensing authority must consult the appropriate committee if the authority proposes to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(3) This paragraph is subject to paragraphs 3 and 4 (exceptions to requirement to consult).

(4) In this Schedule “the appropriate committee” in relation to any function means whichever of the bodies listed in paragraph (5) the licensing authority considers to be the appropriate body to perform that function.

(5) Those bodies are—

(a)the Commission; and

(b)any expert committee appointed by the licensing authority.

Textual Amendments

Exceptions to requirement to consultU.K.

3.—(1) Paragraph 2 does not apply to a proposal to refuse to grant or renew a UK marketing authorisation, certificate of registration or traditional herbal registration [F124, or to a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,] if—U.K.

(a)the licensing authority has asked the applicant to supply information that the licensing authority thinks is relevant to enable the application to be determined [F125or the decision to be made]; and

(b)the information has not been supplied to the authority within the relevant period.

(2) The relevant period is—

(a)where the licensing authority has completed its initial full assessment of the application, the period of six months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1); or

(b)where the licensing authority has completed its assessment of any supplemental information, the period of three months beginning with the date when the authority asked the applicant to supply the information mentioned in sub-paragraph (1).

(3) The licensing authority may extend the relevant period if—

(a)the applicant asks it to do so;

(b)the applicant provides the grounds for that request; and

(c)the licensing authority thinks that the grounds are exceptional.

Textual Amendments

4.—(1) Paragraph 2 does not apply to a proposal to suspend a UK marketing authorisation, certificate of registration or traditional herbal registration if the licensing authority thinks that, in the interests of safety, it is necessary to suspend the authorisation, certificate or registration with immediate effect for not more than three months.U.K.

(2) In that event the licensing authority must report the suspension to the appropriate committee forthwith.

(3) Sub-paragraph (4) applies if, following a suspension to which this paragraph applies—

(a)the licensing authority thinks that the authorisation, certificate or registration should be further suspended, or varied or revoked; or

(b)the appropriate committee advises that the authorisation, certificate or registration should be further suspended, or varied or revoked.

(4) The provisions of this Part of this Schedule (including this paragraph) apply accordingly to the suspension, variation or revocation.

Provisional opinion against authorisationU.K.

5.—(1) If the appropriate committee is consulted under paragraph 2(1) it may give a provisional opinion that on grounds relating to safety, quality or efficacy—U.K.

(a)it may be unable to advise the licensing authority to grant or renew the UK marketing authorisation or traditional herbal registration;

(b)it may be unable to advise the licensing authority to grant the authorisation or registration unless—

(i)it contains terms other than those in the application, or

(ii)it is granted subject to conditions; or

(c)it may have to advise the licensing authority to revoke, vary or suspend the authorisation or registration.

(2) If the Commission is consulted under paragraph 2(2), it may give a provisional opinion that, on grounds relating to safety or quality—

(a)it may be unable to advise the licensing authority to grant or renew the certificate of registration;

(b)it may be unable to advise the licensing authority to grant the certificate unless—

(i)it contains terms other than those in the application, or

(ii)it is granted subject to conditions; or

(c)it may have to advise the licensing authority to revoke, vary or suspend the certificate.

[F126(2A) If the appropriate committee is consulted under paragraph 2(2A), it may give a provisional opinion that it may be unable to advise the licensing authority to decide that the orphan criteria are met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(3) The appropriate committee must notify the applicant for the grant or renewal [F127 , the applicant intending to demonstrate that the orphan criteria are met in relation to a medicinal product,] or (as the case may be) the holder of the authorisation, certificate or registration in writing of its provisional opinion.

Textual Amendments

Opportunity to make representationsU.K.

6.—(1) An applicant or holder notified under paragraph 5 may, by notice in writing to the appropriate committee, request the opportunity to make written or oral representations to the appropriate committee.U.K.

(2) The applicant or holder must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

Written representationsU.K.

7.—(1) If the applicant or holder requests the opportunity to make written representations, the applicant or holder must provide the appropriate committee with those representations and any documents on which the applicant or holder wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

8.—(1) If the applicant or holder requests the opportunity to make oral representations, the applicant or holder must provide the appropriate committee with a written summary of those representations and any documents on which the applicant or holder wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the appropriate committee may specify in the notification under paragraph 5.

(2) The appropriate committee may at the request of the applicant or holder extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 6.

(3) The applicant or holder may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant or holder to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

9.—(1) This paragraph applies if the applicant or holder—U.K.

(a)does not request the opportunity to make written or oral representations to the appropriate committee within the period mentioned in paragraph 6;

(b)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(c)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authorityU.K.

10.—(1) After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must—U.K.

(a)decide whether to grant or renew the UK marketing authorisation, certificate of registration or traditional herbal registration;

(b)decide whether to grant or renew the authorisation, certificate or registration in accordance with the application; F128...

(c)decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration [F129; or

(d)decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,]

as the case may be.

(2) If the appropriate committee has given a report under paragraph 7 or 8, the licensing authority must take the report into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Textual Amendments

Right to review after paragraph 10 notificationU.K.

11.—(1) A person to whom a notification is given under paragraph 10 may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.U.K.

(2) The person must give the notification within the period of 28 days beginning with the day on which the notification under paragraph 10 is given or such longer period as the licensing authority may allow.

(3) The review must be conducted in accordance with Schedule 5.

(4) This paragraph does not apply if—

(a)the person has not made any representations in accordance with paragraph 7 or 8; and

(b)the decision of the licensing authority is in accordance with the advice of the appropriate committee.

Licensing authority decisions in other casesU.K.

12.—(1) This paragraph applies if the appropriate committee has not been consulted under paragraph 2(1) because the licensing authority proposes on grounds not relating to safety, quality or efficacy—U.K.

(a)to refuse to grant or renew a UK marketing authorisation [F130, parallel import licence] or traditional herbal registration in response to the application;

(b)to grant or renew a UK marketing authorisation [F130, parallel import licence] or traditional herbal registration otherwise than in accordance with the application; or

(c)to revoke, vary or suspend a UK marketing authorisation [F130, parallel import licence] or traditional herbal registration.

(2) This paragraph also applies if, having been consulted under paragraph 2(1), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(1), and the licensing authority proposes—

(a)to determine the application for the UK marketing authorisation or traditional herbal registration in a way that differs from the appropriate committee's advice;

(b)to revoke, vary or suspend the authorisation or registration against such advice; or

(c)on grounds not relating to safety, quality or efficacy—

(i)to refuse to grant or renew the authorisation or registration,

(ii)to grant or renew the authorisation or registration otherwise than in accordance with the application, or

(iii)to revoke, vary or suspend the authorisation or registration.

(3) This paragraph also applies if the appropriate committee has not been consulted under paragraph 2(2) because the licensing authority proposes on grounds not relating to safety or quality—

(a)to refuse to grant or renew a certificate of registration in response to the application;

(b)to grant or renew a certificate of registration otherwise than in accordance with the application; or

(c)to revoke, vary or suspend a certificate of registration.

(4) This paragraph also applies if, having been consulted under paragraph 2(2), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2), and the licensing authority proposes—

(a)to determine the application for the certificate of registration in a way that differs from the appropriate committee's advice;

(b)to revoke, vary or suspend the authorisation against such advice; or

(c)on grounds not relating to safety or quality—

(i)to refuse to grant or renew the certificate,

(ii)to grant or renew the certificate otherwise than in accordance with the application, or

(iii)to revoke, vary or suspend the certificate.

[F131(4A) This paragraph also applies if, having been consulted under paragraph 2(2A), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2A) and the licensing authority proposes to decide, against that committee's advice, that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.]

(5) The licensing authority must notify the applicant for the grant or renewal or (as the case may be) the holder of the authorisation [F132, licence], certificate or registration in writing of its proposal.

(6) The notification must state—

(a)the reasons for the proposal; and

(b)any advice of the appropriate committee and any reasons it has given for that advice.

Textual Amendments

Right to review or representations after paragraph 12 notificationU.K.

13.—(1) A person to whom a notification is given under paragraph 12 may—U.K.

(a)notify the licensing authority in writing that the person wishes the licensing authority to submit the proposal to review upon oral representations, or

(b)make representations in writing to the licensing authority with respect to the proposal.

(2) The person must give the notification or make the representations within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(3) A review in accordance with sub-paragraph (1)(a) must be conducted in accordance with Schedule 5.

(4) If the person makes written representations in accordance with sub-paragraph (1)(b) the licensing authority must take them into account before determining the matter.

[F133PART 1AU.K.Paediatric Decisions

Textual Amendments

Application of this PartU.K.

13A.  This Part applies to a proposed decision by the licensing authority—

(a)to refuse to agree a paediatric investigation plan (including a waiver or deferral proposed to be included in that plan), or to agree such a plan otherwise than in accordance with the request for agreement;

(b)to refuse to agree a modification to a paediatric investigation plan (including a waiver or deferral which is, or is proposed to be, included in that plan), or to agree such a modification otherwise than in accordance with the request for the modification;

(c)to impose, revoke or refuse to grant a waiver of the obligation under regulation 50A(3) to provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan; or

(d)to revoke a waiver which was agreed as part of an agreed paediatric investigation plan.

Opportunity to make representationsU.K.

13B.—(1) If the licensing authority proposes to make a decision to which this Part applies, the licensing authority must notify the person to whom the proposed decision would be addressed (“the applicant”).

(2) The applicant may, by notice in writing to the licensing authority, request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request before the end of the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant's request.

Written representationsU.K.

13C.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—

(a)before the end of the period of 28 days beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B.

(2) The appropriate committee may at the request of the applicant extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

13D.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—

(a)before the end of the period of 28 days beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

13E.—(1) This paragraph applies if the applicant—

(a)requests the opportunity to make written representations, but fails to make those representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authorityU.K.

13F.—(1) The licensing authority must decide whether to proceed with its proposed decision—

(a)if the applicant requested the opportunity to make written or oral representations, after receiving the appropriate committee's report under paragraph 13C or 13D or notification under paragraph 13E; or

(b)if the applicant did not request the opportunity to make written or oral representations, after the expiry of the period of time for notifying a request for that opportunity.

(2) If the appropriate committee gives a report under paragraph 13C or 13D, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 13F notificationU.K.

13G.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 13F.

(2) The applicant may notify the licensing authority in writing that the applicant wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification before the end of the period of 28 days beginning with the day on which the notification is given to the applicant under paragraph 13F or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the applicant has not made any representations in accordance with paragraph 13C or 13D.]

PART 2U.K.Type II variation applications, complex variation applications and new excipient variation applications

Application of this PartU.K.

14.  This Part applies—U.K.

(a)to an application (a “Type II variation application”) to vary a UK marketing authorisation if the variation is a major variation of Type II within the meaning of Article 2(3) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M5 [F134or paragraph 1 of Schedule 10A]; and

(b)to an application to vary a traditional herbal registration that is—

(i)a complex variation application, or

(ii)a new excipient variation application.

Textual Amendments

Marginal Citations

M5OJ No L 334, 12.12.2008, p.7.

15.—(1) In paragraph 14(b)(i) “complex variation application” means an application by the holder of the registration to vary it so that one or more of the following changes can be made to the product to which it relates—U.K.

(a)a change in the product's active ingredients by the addition of an active ingredient from a new source;

(b)a change in the product's excipients by the addition of a TSE risk excipient from a new source; or

(c)a change by the addition of a vitamin or mineral from a new source, where no European Pharmacopoeia certificate of suitability for the vitamin or mineral is submitted with the application.

(2) For the purpose of sub-paragraph (1), an ingredient, vitamin or mineral is “from a new source” if its manufacturer as named in the application has not been named as its manufacturer in a [F135UK] marketing authorisation or traditional herbal registration granted for a medicinal product including the ingredient, vitamin or mineral.

(3) For the purpose of sub-paragraph (1), an excipient is a “TSE risk excipient from a new source” if—

(a)it has been manufactured from raw materials of ruminant origin or such raw materials have been used in its manufacture; and

(b)its manufacturer as named in the application has not been named as its manufacturer in a [F136UK] marketing authorisation or traditional herbal registration granted for a medicinal product that includes the excipient.

Textual Amendments

16.—(1) In paragraph 14(b)(ii) “new excipient variation application” means an application (other than a complex variation application) by the holder of the registration to vary it so that the formulation of the medicinal product to which it relates can be changed by the addition of a new excipient.U.K.

(2) For the purpose of sub-paragraph (1) “new excipient” means, subject to paragraphs (3) and (4), an ingredient of a medicinal product that is not an active ingredient and that has not been included in a medicinal product—

(a)intended to be administered by the same route as the product to which the application relates; and

(b)for which a [F137UK] marketing authorisation (other than a product licence of right) or traditional herbal registration has been granted.

(3) In the application of sub-paragraph (1) to a medicinal product intended to be administered orally, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in food or in a food product.

(4) In the application of sub-paragraph (1) to a medicinal product intended for external use only, the reference to a new excipient does not include any ingredient specified in an enactment as an approved ingredient or additive in a cosmetic product.

(5) In this paragraph “enactment” includes an enactment comprised in subordinate legislation F138....

Textual Amendments

[F13917.  In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]U.K.

Textual Amendments

Opportunity to make representationsU.K.

18.—(1) This paragraph applies if the licensing authority notifies the applicant for a variation to which this Part applies that it has decided, on grounds relating to safety, quality or efficacy—U.K.

(a)to refuse to grant the application, or

(b)to grant it otherwise than in accordance with the application.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representationsU.K.

19.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

20.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 18.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 18.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

21.—(1) This paragraph applies if the applicant—U.K.

(a)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following reportU.K.

22.—(1) After receiving the appropriate committee's report under paragraph 19 or 20 or notification under paragraph 21 the licensing authority must confirm or alter its decision.U.K.

(2) If the appropriate committee gives a report under paragraph 19 or 20, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Right to review after paragraph 22 notificationU.K.

23.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 22—U.K.

(a)to refuse the application; or

(b)to grant it otherwise than in accordance with the application.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 19 or 20.

PART 3U.K.Referral to the [F140appropriate committee for traditional herbal registrations]

Textual Amendments

Application of this PartU.K.

24.—(1) This Part applies if the licensing authority proposes to refer an application for a traditional herbal registration to the [F141appropriate committee in accordance with regulation 130A(1)].U.K.

[F142(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.]

Textual Amendments

Opportunity to make representationsU.K.

25.—(1) The licensing authority must notify the applicant of the authority's proposal.U.K.

(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.

Written representationsU.K.

26.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 25.

(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Oral representationsU.K.

27.—(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months beginning with the date of the request; or

(b)before the end of such shorter period as the licensing authority may specify in the notification under paragraph 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 24.

(3) The applicant may submit additional written representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the appropriate committee.

(5) The appropriate committee must—

(a)take the representations made under this paragraph into account; and

(b)report its findings and advice to the licensing authority together with the reasons for that advice.

Other decisions of the appropriate committeeU.K.

28.—(1) This paragraph applies if the applicant—U.K.

(a)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.

Decision of licensing authority following reportU.K.

29.—(1) After receiving the appropriate committee's report under paragraph 26 or 27 or notification under paragraph 28 the licensing authority must decide whether to [F143grant or refuse the application].U.K.

(2) If the appropriate committee gives a report under paragraph 26 or 27, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a)its decision; and

(b)any advice given to it by the appropriate committee and the reasons for that advice.

Textual Amendments

Right to review after paragraph 29 notificationU.K.

30.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 29 to refer the applicant to the Committee on Herbal Medicinal Products as proposed.U.K.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the licensing authority's notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 26 or 27.

PART 4U.K.Exceptions to Schedule

F14431.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

32.  This Schedule does not apply to an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration if the application has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive.U.K.

33.  This Schedule ceases to apply if at any time the matter in question is referred to the Committee for Medicinal Products for Human Use or the Committee for Herbal Medicinal Products under Article 30 or 31 of the 2001 Directive for the application of the procedure laid down in Articles 32 to 34 of that Directive.U.K.

F14534.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F14635.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

36.  This Schedule does not apply if the application or proposal relates to the renewal, revocation, suspension or variation of a UK marketing authorisation that—U.K.

(a)was granted in accordance with the provisions of Chapter 4 of Title III to the 2001 Directive (mutual recognition procedure and decentralised procedure);

(b)was granted before 1st January 1995 by member States in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology M6; or

(c)was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the authorisation.

Marginal Citations

M6OJ No L 15, 17.1.1987. p.38.

F14737.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F14838.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

39.  This Schedule does not apply if—U.K.

(a)the licensing authority refuse to grant an application for a traditional herbal registration;

(b)the application was referred to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive; and

(c)the Committee for Herbal Medicinal Products did not support the grant of the application.

Regulation 128(1)

SCHEDULE 12U.K.Material to accompany an application for a traditional herbal registration

PART 1U.K.General requirements

1.  The name or corporate name and permanent address of the applicant and (where applicable) of the manufacturer of the medicinal product.U.K.

2.  The name of the medicinal product. This may be—U.K.

(a)an invented name that is not liable to confusion with the product's common name; or

(b)a common or scientific name accompanied by a trademark or by the name of the person who is to be the holder of the traditional herbal registration.

3.  Qualitative and quantitative particulars of the constituents of the medicinal product, including—U.K.

(a)where there is an international non-proprietary name recommended by the World Health Organisation for a constituent, a reference to that name; or

(b)otherwise, a reference to the relevant chemical or botanical name.

4.  An evaluation of the potential environmental risks posed by the medicinal product, including an assessment of its environmental impact and a description of the proposed arrangements for limiting that impact on a case by case basis.U.K.

5.  A description of the methods of manufacturing the medicinal product.U.K.

6.  The therapeutic indications and contra-indications for the medicinal product and the adverse reactions associated with it.U.K.

7.  The posology and pharmaceutical form of the medicinal product, its method and route of administration and its expected shelf life.U.K.

8.  The reasons for any precautionary and safety measures to be taken for—U.K.

(a)the storage of the medicinal product;

(b)the administration of the medicinal product to patients; and

(c)the disposal of the medicinal product and any waste products,

with an indication of the potential risks presented by the medicinal product for the environment.

9.  A description of the control methods employed by the manufacturer.U.K.

10.  Results of pre-clinical (toxicological and pharmacological) tests in relation to the medicinal product and its constituent active substances.U.K.

11.  A detailed summary of those results prepared and signed by an expert with appropriate technical or professional qualifications, which must be set out in a brief curriculum vitae.U.K.

12.  A summary of the product characteristics for the medicinal product in accordance with Part 2 of this Schedule.U.K.

13.  A mock-up, in accordance with Part 13 (packaging and leaflets) of—U.K.

(a)the outer packaging of the medicinal product;

(b)the immediate packaging of the medicinal product; and

(c)the package leaflet for the medicinal product.

14.  A document showing that the manufacturer of the medicinal product is authorised to produce medicinal products in the manufacturer's own country.U.K.

15.  Where the medicinal product consists of a combination of one or more herbal substances and one or more herbal preparations, or the medicinal product contains one or more vitamins or minerals—U.K.

(a)data on the traditional use of the medicinal product as a whole; and

(b)if any of the medicinal product's individual active ingredients are not sufficiently known, data on the traditional use of those active ingredients.

This covers (in particular)—

(c)evidence that the product is not harmful in the specified conditions of use; and

(d)evidence as to the pharmacological effects or efficacy of the product on the basis of long-standing use and experience.

16.  Details of any authorisation or registration obtained by the applicant in [F149a country other than the United Kingdom] allowing the medicinal product to be placed on the market.U.K.

Textual Amendments

17.  Details of any decision in [F150a country other than the United Kingdom] to refuse to grant an authorisation or registration allowing the medicinal product to be placed on the market, with the reasons for any such decision.U.K.

Textual Amendments

18.  Bibliographical or expert evidence of the traditional use of the medicinal product or a product corresponding to the medicinal product.U.K.

For this purpose a product (“A”) corresponds to a medicinal product (“B”) if—

(a)product A has the same active ingredients as product B (regardless of the excipients used in either product);

(b)product A's intended purpose is the same as or similar to product B's intended purpose;

(c)product A has a strength and dosage equivalent to that of product B; and

(d)product A's route of administration is the same as or similar to product B's route of administration.

19.  A bibliographic review of safety data.U.K.

20.  An expert report on safety.U.K.

PART 2U.K.Summary of the product characteristics

The summary of the product characteristics must contain the following information in the following order—

21.  For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004 [F151or regulation 202A, as the case may be], the [F152symbol and] statement “[F153▼] This medicinal product is subject to additional monitoring”.U.K.

Textual Amendments

22.  The name of the medicinal product followed by its strength and pharmaceutical form.U.K.

23.  The qualitative and quantitative composition, using the usual common name or chemical description, of the medicinal product in terms of—U.K.

(a)the active substances; and

(b)those excipients of which knowledge is essential for proper administration of the medicinal product.

24.  The pharmaceutical form of the medicinal product.U.K.

25.  The pharmacological properties of the medicinal product, covering—U.K.

(a)pharmacodynamic properties;

(b)pharmacokinetic properties; and

(c)pre-clinical safety data.

26.  Pharmaceutical particulars of the medicinal product, covering—U.K.

(a)a list of excipients;

(b)major incompatibilities;

(c)shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d)special precautions for storage;

(e)nature and contents of the container; and

(f)special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).

27.  The holder of the traditional herbal registration.U.K.

28.  The number of the traditional herbal registration.U.K.

29.  The date of the first traditional herbal registration or, where the traditional herbal registration has been renewed, the date of the last renewal.U.K.

30.  The date of any revisions of the text of the summary of the product characteristics.U.K.

Regulation 205A

[F154SCHEDULE 12AU.K.Further provision as to the performance of pharmacovigilance activities

Textual Amendments

PART 1U.K.Pharmacovigilance system master file

Structure of the pharmacovigilance system master fileU.K.

1.—(1) The information in the pharmacovigilance system master file must be accurate and reflect the pharmacovigilance system in place.

(2) The holder may, where appropriate, use separate pharmacovigilance systems for different categories of medicinal products and if it does so, each such system must be described in a separate pharmacovigilance system master file.

(3) All medicinal products for which the holder obtained a UKMA(GB) in accordance with these Regulations must be covered by a pharmacovigilance system master file.

Content of the pharmacovigilance system master fileU.K.

2.  The pharmacovigilance system master file must, as a minimum, contain—

(a)the following information relating to the qualified person responsible for pharmacovigilance—

(i)a description of the responsibilities demonstrating that the qualified person for pharmacovigilance has sufficient authority over the pharmacovigilance system in order to promote, maintain and improve compliance with pharmacovigilance tasks and responsibilities,

(ii)a summary curriculum vitae of the qualified person responsible for pharmacovigilance,

(iii)contact details of the qualified person for pharmacovigilance,

(iv)details of back-up arrangements to apply in the absence of the qualified person responsible for pharmacovigilance, and

(v)responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));

(b)a description of the organisational structure of the holder, including the list of each site where one or more of the following pharmacovigilance activities are undertaken—

(i)individual case safety report collection and evaluation,

(ii)safety database case entry,

(iii)periodic safety update report production,

(iv)signal detection and analysis,

(v)risk management plan management,

(vi)pre and post-authorisation study management, and

(vii)management of safety variations to the terms of a UK marketing authorisation;

(c)a description of the location of, functionality of and operational responsibility for computerised systems and databases used to receive, collate, record and report safety information, and an assessment of their fitness for purpose;

(d)a description of data handling and recording and of the process used for each of the following pharmacovigilance activities—

(i)the continuous monitoring of the risk-benefit balance of each medicinal product, the result of that monitoring and the decision-making process for taking appropriate measures,

(ii)operation of each risk management system and of the monitoring of the outcome of risk minimisation measures,

(iii)collection, assessment and reporting of individual case safety reports,

(iv)drafting and submission of periodic safety update reports, and

(v)procedures for communicating safety concerns and safety variations to the summary of product characteristics and package leaflet to healthcare professionals and the general public;

(e)a description of the quality system for the performance of pharmacovigilance activities, including—

(i)a description of—

(aa)the organisational structure for the performance of pharmacovigilance activities,

(bb)a summary description of the training concept, including a reference to the location of training files and qualifications records, and

(cc)instructions on critical processes,

(ii)a description of the record management system referred to in paragraph 12, including the location of the documents used for pharmacovigilance activities,

(iii)a description of the system for monitoring the performance of the pharmacovigilance system; and

(f)where applicable, a description of the activities or services subcontracted by the holder.

Content of the Annex to the pharmacovigilance system master fileU.K.

3.  The pharmacovigilance system master file must have an Annex containing the following documents—

(a)a list of medicinal products covered by the pharmacovigilance system master file, including the name of each medicinal product, the international non-proprietary name (INN) of each active substance and the countries other than the United Kingdom in which the products covered are authorised to be marketed;

(b)a list of written policies and procedures for the purpose of complying with Part 11 of these Regulations;

(c)the list of any sub-contracts falling within paragraph 6(1);

(d)a list of the tasks that have been delegated by the qualified person for pharmacovigilance;

(e)a list of all scheduled and completed audits;

(f)where applicable, a list of the performance indicators that support the quality system for pharmacovigilance specified in paragraph 2(e);

(g)where applicable, a list of other pharmacovigilance system master files held by the same holder; and

(h)a logbook containing a record of any alteration of the content of the pharmacovigilance system master file made within the preceding 5 year period, except any alteration of the content that is specified in of paragraph 2(a)(ii) to (iv) or this paragraph.

Maintenance of the pharmacovigilance system master fileU.K.

4.—(1) The holder must keep the pharmacovigilance system master file up to date and, where necessary, revise it to take account of experience gained, and of technical and scientific progress.

(2) The pharmacovigilance system master file and its Annex must be subject to version control and, in particular, must indicate the date when it was last updated by the holder.

(3) Any deviations from the pharmacovigilance procedures, their impact and their management must be documented in the pharmacovigilance system master file until resolved.

Form of the documents contained in the pharmacovigilance system master fileU.K.

5.—(1) The pharmacovigilance system master file documents must be complete and legible.

(2) Subject to sub-paragraph (1), in the pharmacovigilance system master file—

(a)where appropriate, information may be provided in the form of charts or flow diagrams;

(b)all documents must be indexed and archived so as to ensure their accurate and ready retrieval throughout the period for record-keeping; and

(c)the particulars and documents may be presented in modules in accordance with the system delineated in detail in the guidance on good pharmacovigilance practices which applies by virtue of regulation 205B.

(3) The pharmacovigilance system master file may be stored in electronic form provided that the media used for storage remain readable over time, and a clearly arranged printed copy can be made available for audits and inspections.

SubcontractingU.K.

6.—(1) The holder may subcontract certain activities of the pharmacovigilance system to third parties, but if it does so it must nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file.

(2) The holder must draw up a list of the existing subcontracts between it and the third parties referred to in sub-paragraph (1), specifying each product and each country concerned.

Availability and location of the pharmacovigilance system master fileU.K.

7.—(2) The holder must ensure that the qualified person and nominated person (where a person is nominated under regulation 182(2A)) for pharmacovigilance have permanent access to the pharmacovigilance system master file.

(3) For the purposes of regulation 182(2)(b), the licensing authority may limit its request to specific parts or modules of the pharmacovigilance system master file and the holder is to bear the costs of submitting the copy of the pharmacovigilance system master file.

(4) The licensing authority may request the holder to submit a copy of the logbook referred to in paragraph 3(h) at regular intervals.

PART 2U.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders

Quality systemU.K.

8.—(1) Any holder, and the licensing authority, must establish and use a quality system that is adequate and effective for the performance of their pharmacovigilance activities.

(2) The quality system must cover organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management.

(3) The quality system must be based on all of the following activities—

(a)quality planning: establishing structures and planning integrated and consistent processes;

(b)quality adherence, namely carrying out tasks and responsibilities in accordance with quality requirements;

(c)quality control and assurance, namely monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out; and

(d)quality improvements, namely correcting and improving the structures and processes where necessary.

(4) All elements, requirements and provisions adopted for the quality system must be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records.

(5) All persons involved in the procedures and processes of the quality systems established by the licensing authority for the performance of pharmacovigilance activities shall be responsible for the good functioning of those quality systems, and must ensure a systematic approach towards quality and towards the implementation and maintenance of the quality system.

Performance indicatorsU.K.

9.—(1) The holder and the licensing authority may use performance indicators to continuously monitor the good performance of pharmacovigilance activities.

(2) The licensing authority may publish a list of performance indicators.

PART 3U.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders

Management of human resourcesU.K.

10.—(1) The holder must have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.

(2) For the purposes of sub-paragraph (1), the holder must—

(a)ensure that the qualified person responsible for pharmacovigilance has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities; and

(b)where the qualified person has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person, with such assistance being duly documented.

(3) The duties of the managerial and supervisory staff, including the qualified person responsible for pharmacovigilance, must be defined in job descriptions and their hierarchical relationships must be defined in an organisational chart.

(4) The holder must ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the holder.

(5) All personnel involved in the performance of pharmacovigilance activities must receive initial and continued training in relation to their role and responsibilities, and the holder must keep training plans and records for documenting, maintaining and developing the competences of personnel and make them available for audit or inspection.

(6) The holder must provide appropriate instructions on the processes to be used in case of urgency, including business continuity.

Compliance managementU.K.

11.—(1) Specific quality system procedures and processes must be in place in order to ensure the following—

(a)the continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and that appropriate measures are taken by the holder;

(b)the scientific evaluation by the holder of all information on the risks of medicinal products, as referred to in regulation 182(4)(a);

(c)the submission of accurate and verifiable data on serious and non-serious adverse reactions to the licensing authority within the time limits provided for in regulation 188(1)(a) or (b);

(d)the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions;

(e)effective communication by the holder with the licensing authority, including communication on—

(i)new risks or changed risks,

(ii)the pharmacovigilance system master file,

(iii)risk management systems,

(iv)risk minimisation measures,

(v)periodic safety update reports,

(vi)corrective and preventive actions, and

(vii)post-authorisation studies;

(f)the update of product information by the holder in the light of scientific knowledge, including the assessments and recommendations made public via the UK web-portal, and on the basis of a continuous monitoring by the holder of information published on that web-portal; and

(g)appropriate communication by the holder of relevant safety information to healthcare professionals and patients.

(2) Where a holder has subcontracted some of its pharmacovigilance tasks, it must retain responsibility for ensuring that an effective quality system is applied in relation to those tasks.

Record management and data retentionU.K.

12.—(1) A holder must record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.

(2) A holder must put in place a record management system for all documents used for pharmacovigilance activities that ensures—

(a)the retrievability of those documents; and

(b)the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.

(3) A holder must establish mechanisms enabling the traceability and follow-up of adverse reaction reports.

(4) A holder must arrange for the elements referred to in sub-paragraph (2) to be kept for at least five years, beginning with the day after the system as described in the pharmacovigilance system master file has been formally terminated by the holder.

(5) Pharmacovigilance data and documents relating to individual authorised medicinal products must be retained as long as the product is authorised and for at least 10 years, beginning with the date on which the UKMA(GB) ceased to exist.

AuditU.K.

13.—(1) Risk-based audits of the quality system must be performed at regular intervals to ensure that the quality system complies with the quality system requirements set out in paragraphs 8, 10, 11 and 12, and to determine its effectiveness.

(2) The audits referred to in sub-paragraph (1) must be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited.

(3) Following a risk-based audit—

(a)any corrective action, including a follow-up audit of deficiencies, must be taken where necessary;

(b)a report on the results of the audit must be drawn up for each audit and follow-up audit;

(c)the audit report must be sent to the management responsible for the matters audited; and

(d)the dates and results of audits and follow-up audits must be documented in accordance with regulation 184(1)(b).

PART 4U.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority

Management of human resourcesU.K.

14.—(1) The licensing authority must have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities: the organisational structures and the distribution of tasks and responsibilities must be clear and, to the extent necessary, accessible.

(2) Named contact points in the licensing authority for pharmacovigilance activities must be established.

(3) The licensing authority must ensure that—

(a)all of its personnel involved in the performance of pharmacovigilance activities receive initial and continued training;

(b)it keeps training plans and records for documenting, maintaining and developing the competences of personnel; and

(c)such plans and records are available for audit.

(4) The licensing authority must ensure that it provides to its personnel performing pharmacovigilance activities appropriate instructions on the processes to be used in case of urgency, including business continuity.

Compliance managementU.K.

15.  The licensing authority must establish specific procedures and processes in order to achieve the following objectives—

(a)ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted;

(b)ensuring the assessment of pharmacovigilance data and its processing within the timelines provided for in Part 11 of these Regulations;

(c)ensuring independence in the performance of pharmacovigilance activities;

(d)ensuring effective communication among regulatory bodies in countries other than the United Kingdom who have the same or similar functions as the licensing authority, as well as with patients, healthcare professionals, marketing authorisation holders and the general public; and

(e)conducting inspections, including pre-authorisation inspections.

Record management and data retentionU.K.

16.—(1) The licensing authority must—

(a)record all pharmacovigilance information, and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information; and

(b)put in place a record management system for all documents used for pharmacovigilance activities that ensures—

(i)the retrievability of those documents, and

(ii)the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.

(2) The licensing authority must arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years, such period beginning with the day after the system has been formally terminated.

(3) Pharmacovigilance data and documents relating to individual authorised medicinal products must be retained by the licensing authority for as long as the product is authorised and for at least 10 years, such period beginning with the day after the UKMA(GB) has expired.

AuditU.K.

17.—(1) Risk-based audits of the quality system must be performed by the licensing authority at regular intervals to ensure that the quality system complies with the requirements set out in paragraphs 8, 14, 15 and 16, and to ensure its effectiveness.

(2) Following a risk-based audit—

(a)any corrective action, including a follow-up audit of deficiencies, must be taken where necessary;

(b)a report on the results of the audit must be drawn up for each audit and follow-up audit;

(c)the audit report must be sent to the management responsible for the matters audited; and

(d)the dates and results of audits and follow-up audits must be documented.

PART 5U.K.Use of terminology, formats and standards

Use of internationally agreed terminology, formats and standardsU.K.

18.  The licensing authority may publish a list of which of the internationally agreed—

(a)terminology; and

(b)formats and standards,

are to be used for the description, classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information.

PART 6U.K.Transmission of reports of suspected adverse reactions

Individual case safety reportsU.K.

19.  Individual case safety reports must be used for reporting to the licensing authority suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.

Content of the individual case safety reportU.K.

20.—(1) Holders must—

(a)ensure that individual case safety reports are as complete as possible; and

(b)communicate the updates of those reports to the licensing authority in an accurate and reliable manner.

(2) In the case of expedited reporting, the individual case safety report must include at least an identifiable reporter, an identifiable patient, one suspected adverse reaction and any medicinal product concerned.

(3) Holders and the licensing authority must record the details necessary for obtaining follow-up information on individual case safety reports and such reports must be adequately documented.

(4) When reporting suspected adverse reactions, holders must provide all available information on each individual case, including—

(a)administrative information, namely—

(i)report type, date and a worldwide unique case identification number as well as unique sender identification and sender type,

(ii)the date on which the report was first received from the source and the date of receipt of the most recent information, using a precise date, and

(iii)other case identifiers and their sources, as well as references to additional available documents held by the sender of the individual case safety report, where applicable;

(b)literature reference in accordance with the ‘Vancouver style’ as developed by the International Committee of Medical Journal Editors for adverse reactions reported in the worldwide literature, including a comprehensive English summary of the article;

(c)study type, study name and the sponsor's study number or study registration number for reports from studies not covered by the Clinical Trials Regulations;

(d)information on any primary source, namely information identifying the reporter, including country of residence and professional qualifications;

(e)information identifying the patient (and parent in the case of a parent-child report), including age at the time of the onset of the first reaction, age group, gestation period when reaction or event was observed in the foetus, weight, height or gender, last menstrual date and, where relevant, gestation period at time of exposure;

(f)relevant medical history and concurrent conditions;

(g)the name of any medicinal product suspected to be related to the occurrence of the adverse reaction, including interacting medicinal products or, where the name is not known, any active substance and any other characteristics that allow for the identification of a medicinal product, including—

(i)the name of the holder, UK marketing authorisation number, pharmaceutical form and each (parent) route of administration,

(ii)any indication for use in the case, dose administered, start date and end date of administration,

(iii)actions taken with any medicinal product, and

(iv)effect of the dechallenge and rechallenge for suspect medicinal products;

(h)for a biological medicinal product, the batch number;

(i)concomitant medicinal products, identified in accordance with paragraph (g), which are not suspected to be related to the occurrence of the adverse reaction and past-medical drug therapy for the patient (and for the parent), where applicable;

(j)information on any suspected adverse reaction, including—

(i)start date and end date of any suspected adverse reaction or duration,

(ii)seriousness,

(iii)outcome of any suspected adverse reaction at the time of last observation,

(iv)time intervals between suspect medicinal product administration and start of any adverse reaction,

(v)the original reporter's words or short phrases used to describe any reaction, and

(vi)country of occurrence of the suspected adverse reaction;

(k)results of tests and procedures relevant to the investigation of the patient;

(l)in the event of death of the patient, date and reported cause of death, including autopsy-determined causes;

(m)a case narrative, where possible, providing all relevant information for individual cases with the exception of non-serious adverse reactions; and

(n)reasons for nullifying or amending an individual case safety report.

(5) For the purposes of—

(a)sub-paragraph (4)(b), upon request of the licensing authority, the holder that transmitted the initial report must provide a copy of the relevant article taking into account copyright restrictions, and a full translation of that article into English;

(b)sub-paragraph (4)(h), a follow-up procedure must be in place to obtain the batch number where it is not indicated in the initial report;

(c)sub-paragraph (4)(m), the information must be presented in a logical time sequence, in the chronology of the patient's experience including clinical course, therapeutic measures, outcome and follow-up information obtained: any relevant autopsy or post-mortem findings must also be summarised in the narrative.

(6) Suspected adverse reactions must be reported in English.

Format of electronic transmission of suspected adverse reactionsU.K.

21.  Holders must use the formats and terminology specified in the list published under paragraph 18 for the electronic transmission of suspected adverse reactions, if the licensing authority has published a list under that paragraph.

PART 7U.K.Risk management plans

Content of the risk management planU.K.

22.—(1) The risk management plan established by the holder must contain the following elements—

(a)an identification or characterisation of the safety profile of the medicinal product concerned;

(b)an indication of how to characterise further the safety profile of the medicinal product(s) concerned;

(c)a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those measures; and

(d)a documentation of post-authorisation obligations that have been imposed as a condition of the UKMA(GB).

(2) Medicinal products may, where appropriate be subject to the same risk management plan if they—

(a)contain the same active substance; and

(b)belong to the same holder.

(3) Where a risk management plan refers to post-authorisation studies—

(a)it must indicate whether those studies are initiated, managed or financed by the holder voluntarily, or pursuant to obligations imposed by the licensing authority or an equivalent authority to the licensing authority in another country; and

(b)all post-authorisation obligations must be listed in the summary of the risk management plan referred to in paragraph 23, together with a timeframe for meeting those obligations.

Summary of the risk management planU.K.

23.—(1) The summary of the risk management plan to be made publicly available in accordance with regulation 203(2)(d) (obligations on licensing authority in relation to national medicines web-portal) must include key elements of the risk management plan with a specific focus on risk minimisation activities and, with regard to the safety specification of the medicinal product concerned, important information on potential and identified risks as well as missing information.

(2) Where a risk management plan concerns more than one medicinal product, a separate summary of the risk management plan must be provided by holders for each medicinal product.

Updates of the risk management planU.K.

24.—(1) Subject to sub-paragraph (2), where the holder updates a risk management plan, it must submit the updated risk management plan to the licensing authority.

(2) If the licensing authority agrees, the holder may submit only the modules concerned by the update.

(3) If necessary, the holder must provide the licensing authority with an updated summary of the risk management plan.

(4) Each submission of the risk management plan must—

(a)have a distinct version number; and

(b)be dated.

Format of the risk management planU.K.

25.  The risk management plan must be in the following format—

(a)Part I: product overview;

(b)Part II: safety specification consisting of—

(i)Module SI: epidemiology of each indication and each target population,

(ii)Module SII: non-clinical part of the safety specification,

(iii)Module SIII: clinical trial exposure,

(iv)Module SIV: populations not studied in clinical trials,

(v)Module SV: post-authorisation experience,

(vi)Module SVI: additional EU requirements for the safety specification,

(vii)Module SVII: identified and potential risks, and

(viii)Module SVIII: summary of the safety concerns;

(c)Part III: pharmacovigilance plan, including post-authorisation safety studies;

(d)Part IV: plans for post-authorisation efficacy studies;

(e)Part V: risk minimisation measures, including evaluation of the effectiveness of risk minimisation activities;

(f)Part VI: summary of the risk management plan; and

(g)Part VII: annexes.

PART 8U.K.Periodic safety update reports

Content of periodic safety update reportsU.K.

26.—(1) The periodic safety update report (“PSUR” ) must—

(a)be based on all available data; and

(b)focus on new information which has emerged since the data lock point of the last PSUR.

(2) The PSUR must provide an accurate estimate of the population exposed to the medicinal product, including all data relating to the volume of sales and volume of prescriptions.

(3) The estimate of exposure referred to in sub-paragraph (2) must be accompanied by a qualitative and quantitative analysis of actual use, which must indicate, where appropriate, how actual use differs from the indicated use based on all data available to the holder, including the results of observational or drug utilisation studies.

(4) The PSUR must contain the results of assessments of the effectiveness of risk minimisation activities relevant to the risk–benefit assessment.

(5) Where any conditions are imposed under regulation 59(4A) (conditions in relation to UK marketing authorisations to which paediatric specific provisions apply) or 59(4D) (conditions in relation to UK marketing authorisations for advanced therapy medicinal products), the PSUR must also include an assessment of the effectiveness of any risk management system, and the results of any studies performed, in order to comply with those conditions.

(6) Subject to sub-paragraph (7), holders are not required to include systematically detailed listings of individual cases, including case narratives, in the PSUR.

(7) Holders must provide case narratives in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section.

(8) Based on the evaluation of the cumulative safety data and the risk-benefit analysis, the holder must draw conclusions in the PSUR as to the need for changes or actions, including implications for the approved summary of product characteristics for each product for which the PSUR is submitted.

(9) Unless otherwise agreed with the licensing authority, a single PSUR must be prepared for all medicinal products which—

(a)contain the same active substance; and

(b)are authorised for the same holder,

and sub-paragraph (10) applies to that single PSUR.

(10) Where this sub-paragraph applies—

(a)the PSUR must cover all indications, routes of administration, dosage forms and dosing regimens, irrespective of whether authorised under different names and through separate procedures; and

(b)where relevant, data relating to a particular indication, dosage form, route of administration or dosing regimen must be presented in a separate section of the PSUR, with any safety concerns addressed accordingly.

(11) Unless otherwise agreed with the licensing authority, if the substance that is the subject of the PSUR is also authorised as a component of a fixed combination medicinal product, the holder must either—

(a)submit a separate PSUR for the combination of active substances authorised for the same holder, with cross-references to each relevant single-substance PSUR; or

(b)provide the combination data within one of the single-substance PSURs.

Format of periodic safety update reportsU.K.

27.—(1) Electronic PSURs must be submitted in the following format—

(a)Part I: title page including signature;

(b)Part II: executive summary; and

(c)Part III: table of contents which contains—

(i)introduction,

(ii)worldwide marketing authorisation status,

(iii)actions taken in the reporting interval for safety reasons,

(iv)changes to reference safety information,

(v)estimated exposure and use patterns—

(aa)cumulative subject exposure in clinical trials,

(bb)cumulative and interval patient exposure from marketing experience,

(vi)data in summary tabulations—

(aa)reference information,

(bb)cumulative summary tabulations of serious adverse events in clinical trials,

(cc)cumulative and interval summary tabulations from post-marketing data sources,

(vii)summaries of significant findings from clinical trials during the reporting interval—

(aa)completed clinical trials,

(bb)ongoing clinical trials,

(cc)long-term follow-up,

(dd)other therapeutic use of medicinal product,

(ee)new safety data related to fixed combination therapies,

(viii)findings from non-interventional studies,

(ix)information from other clinical trials and sources,

(x)non-clinical data,

(xi)literature,

(xii)other periodic reports,

(xiii)lack of efficacy in controlled clinical trials,

(xiv)late-breaking information,

(xv)overview on signals: new, ongoing or closed,

(xvi)signal and risk evaluation—

(aa)summaries of safety concerns,

(bb)signal evaluation,

(cc)evaluation of risks and new information,

(dd)characterisation of risks, and

(ee)effectiveness of risk minimisation (if applicable),

(xvii)benefit evaluation—

(aa)important baseline efficacy and effectiveness information,

(bb)newly identified information on efficacy and effectiveness, and

(cc)characterisation of benefits,

(xviii)integrated benefit-risk analysis for authorised indications—

(aa)benefit-risk context: medical need and important alternatives, and

(bb)benefit-risk analysis evaluation,

(xix)conclusions and actions, and

(xx)appendices to the PSUR.

(2) In this paragraph, “signal evaluation” means the process of further evaluating a validated signal taking into account all available evidence, to determine whether there are new risks causally associated with the active substance or medicinal product, or whether known risks have changed, and that process—

(a)may include non-clinical and clinical data; and

(b)must be as comprehensive as possible regarding the sources of information used for that process.

PART 9U.K.Post-authorisation safety studies

Scope and interpretationU.K.

28.—(1) This Part applies to non-interventional post-authorisation safety studies initiated, managed or financed by a holder under obligations imposed under regulation 59 or 61 (conditions of UK marketing authorisation).

(2) In this Part—

“start of data collection” means the date on which information on the first study subject is first recorded in the study dataset or, in the case of the secondary use of data, the date on which the data extraction starts; and

“end of data collection” means the date on which the analytical dataset is completely available.

Obligations as to post-authorisation safety studiesU.K.

29.—(1) The holder must submit in English—

(a)the study protocol; and

(b)the abstract of the final study report and the final study report.

(2) The holder must ensure that—

(a)all study information is handled and stored so as to allow for accurate reporting, interpretation and verification of that information;

(b)the confidentiality of the records of the study subjects remains protected; and

(c)the analytical dataset and statistical programmes used for generating the data included in the final study report are kept in electronic format and are available for auditing and inspection.

(3) The licensing authority may publish appropriate templates for the protocol, abstract and final study report.

Format of the study protocolU.K.

30.  The study protocol for a non-interventional post-authorisation safety studies must be submitted in the following format—

(a)title: informative title including a commonly used term indicating the study design and the medicinal product, substance or drug class concerned, and a sub-title with a version identifier and the date of the last version;

(b)name of holder;

(c)responsible parties including a list of all collaborating institutions and other relevant study sites.

(d)abstract, which must consist of a stand-alone summary of the study protocol, including the following subsections—

(i)title with subtitles including version and date of the protocol and name and affiliation of the main author,

(ii)rationale and background,

(iii)research question and objectives,

(iv)study design,

(v)population,

(vi)variables,

(vii)data sources,

(viii)study size,

(ix)data analysis, and

(x)milestones;

(e)amendments and updates, namely any substantial amendment and update to the study protocol after the start of data collection, including a justification for the amendment or update, the date of the change, and a reference to the section of the protocol where the change has been made.

(f)milestones, namely a table with planned dates for the following milestones—

(i)start of data collection,

(ii)end of data collection,

(iii)any study progress report as referred to in regulation 198(2),

(iv)any interim report of study results, if applicable, and

(v)final report of study results;

(g)rationale and background, namely a description of any safety hazard, the safety profile or the risk management measures that led to the study being imposed as an obligation for a UKMA(GB);

(h)research question and objectives in accordance with the decision of the licensing authority in imposing the study as an obligation;

(i)research methods, namely a description of the research methods, including—

(i)study design,

(ii)setting, namely the study population defined in terms of persons, place, time period, and selection criteria, including the rationale for any inclusion and exclusion criteria: where any sampling from a source population is undertaken, a description of the source population and details of sampling methods must be provided and where the study design is a systematic review or a meta-analysis, the criteria for the selection and eligibility of studies must be explained,

(iii)variables,

(iv)data sources, namely strategies and data sources for determining exposures, outcomes and all other variables relevant to the study objectives: where the study will use an existing data source, such as electronic health records, any information on the validity of the recording and coding of the data must be reported and in the case of a systematic review or meta-analysis, the search strategy and processes and any methods for confirming data from investigators must be described,

(v)study size, namely any projected study size, precision sought for study estimates and any calculation of the study size that can minimally detect a pre-specified risk with a pre-specified interpretative power,

(vi)data management,

(vii)data analysis,

(viii)quality control, and

(ix)limitations of the research methods;

(j)protection of human subjects, namely safeguards in order to comply with national requirements for ensuring the well-being and rights of participants in non-interventional post-authorisation safety studies;

(k)management and reporting of adverse events or adverse reactions and other medically important events while the study is being conducted;

(l)plans for disseminating and communicating study results; and

(m)references.

Format of the abstract of the final study reportU.K.

31.  The abstract of the final study report for a non-interventional post-authorisation safety studies must be submitted in the following format—

(a)title, with subtitles including date of the abstract and name and affiliation of main author;

(b)keywords (not more than five keywords indicating the main study characteristics);

(c)rationale and background;

(d)research question and objectives;

(e)study design;

(f)setting;

(g)subjects and study size, including dropouts;

(h)variables and data sources;

(i)results;

(j)discussion (including, where relevant, an evaluation of the impact of study results on the risk–benefit balance of the product);

(k)name of holder; and

(l)names and affiliations of principal investigators.

Format of the final study reportU.K.

32.  The final study report for a non-interventional post-authorisation safety studies must be submitted in the following format—

(a)title, including a commonly used term indicating the study design; sub-titles with date of final report and name and affiliation of the main author;

(b)abstract, namely a stand-alone summary referred to in paragraph 31;

(c)name and address of the holder;

(d)investigators, namely the names, titles, degrees, addresses and affiliations of the principal investigator and all co-investigators, and list of all collaborating primary institutions and other relevant study sites;

(e)milestones, namely the dates for the following milestones—

(i)start of data collection (planned and actual dates),

(ii)end of data collection (planned and actual dates),

(iii)study progress reports,

(iv)interim reports of study results, where applicable,

(v)final report of study results (planned and actual date), and

(vi)any other important milestone applicable to the study, including date of study registration in the electronic study register

(f)rationale and background, namely a description of the safety concerns that led to the study being initiated, and critical review of relevant published and unpublished data evaluating pertinent information and gaps in knowledge that the study is intended to fill;

(g)research question and objectives;

(h)amendments and updates to the protocol, namely a list of any substantial amendments and updates to the initial study protocol after the start of data collection, including a justification for each amendment or update;

(i)research methods, namely—

(i)study design: key elements of the study design and rationale for this choice,

(ii)setting: setting, locations, and relevant dates for the study, including periods of recruitment, follow-up, and data collection: in the case of a systematic review or meta-analysis, study characteristics used as criteria for eligibility, with rationale,

(iii)subjects: any source population and eligibility criteria for study subjects. Sources and methods for selection of participants shall be provided, including, where relevant, methods for case ascertainment, as well as number of and reasons for dropouts,

(iv)variables: all outcomes, exposures, predictors, potential confounders, and effect modifiers, including operational definitions: diagnostic criteria shall be provided, where applicable,

(v)data sources and measurement: for each variable of interest, sources of data and details of methods of assessment and measurement; if the study has used an existing data source, such as electronic health records, any information on the validity of the recording and coding of the data must be reported and in the case of a systematic review or meta-analysis, description of all information sources, search strategy, methods for selecting studies, methods of data extraction and any processes for obtaining or confirming data from investigators,

(vi)bias,

(vii)study size: study size, rationale for any study size calculation and any method for attaining projected study size,

(viii)data transformation: transformations, calculations or operations on the data, including how quantitative data were handled in the analyses and which groupings were chosen and why,

(ix)statistical methods: description of the following items—

(aa)main summary measures,

(bb)all statistical methods applied to the study,

(cc)any methods used to examine subgroups and interactions,

(dd)how missing data were addressed,

(ee)any sensitivity analyses, and

(ff)any amendment to the plan of data analysis included in the study protocol, with rationale for the change, and

(x)quality control: mechanisms to ensure data quality and integrity;

(j)results: comprising the following subsections—

(i)participants, namely numbers of study subjects at each stage of study: in the case of a systematic review or meta-analysis, number of studies screened, assessed for eligibility and included in the review with reasons for exclusion at each stage,

(ii)descriptive data: characteristics of study participants, information on exposures and potential confounders and number of participants with missing data. In the case of a systematic review or meta-analysis, characteristics of each study from which data were extracted,

(iii)outcome data: numbers of study subjects across categories of main outcomes,

(iv)main result: unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision and where relevant, estimates of relative risk must be translated into absolute risk for a meaningful time period,

(v)other analyses, and

(vi)adverse events and adverse reactions;

(k)discussion which must include—

(i)key results with reference to the study objectives, prior research in support of and conflicting with the findings of the completed post-authorisation safety study, and, where relevant, the impact of the results on the risk–benefit balance of the product,

(ii)limitations of the study taking into account circumstances that may have affected the quality or integrity of the data, limitations of the study approach and methods used to address them, sources of potential bias and imprecision, and validation of the events; both the direction and magnitude of potential biases must be discussed,

(iii)interpretation of results, considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence, and

(iv)generalisability; and

(l)references.]

Regulations 214(4) and 216(1)

SCHEDULE 13U.K.Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners

  • Co-danthramer Capsules NPF

  • Co-danthramer Capsules Strong NPF

  • Co-danthramer Oral Suspension NPF

  • Co-danthramer Oral Suspension Strong NPF

  • Co-danthrusate Capsules

  • Co-danthrusate Oral Suspension NPF

  • Mebendazole Tablets NPF

  • Mebendazole Oral Suspension NPF

  • Miconazole Oral Gel NPF

  • Nystatin Oral Suspension

  • Nystatin Pastilles NPF

  • Streptokinase and Streptodornase Topical Powder NPF

  • Water for injections

  • In this Schedule “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.

Regulation 215

SCHEDULE 14U.K.Prescription etc by supplementary prescribers: particulars of clinical management plan

A clinical management plan must contain the following particulars—

(a)the name of the patient to whom the plan relates;

(b)the illnesses or conditions which may be treated by the supplementary prescriber;

(c)the date on which the plan is to take effect and when it is to be reviewed by the doctor or dentist who is a party to the plan;

(d)reference to the class or description of medicinal product which may be prescribed or administered under the plan;

(e)any restrictions or limitations as to the strength or dose of any product which may be prescribed or administered under the plan, and any period of administration or use of any medicinal product which may be prescribed or administered under the plan;

(f)relevant warnings about the known sensitivities of the patient to, or known difficulties of the patient with, particular medicinal products;

(g)the arrangements for notification of—

(i)suspected or known adverse reactions to any medicinal product which may be prescribed or administered under the plan, and

(ii)suspected or known adverse reactions to any other medicinal product taken at the same time as any medicinal product prescribed or administered under the plan; and

(h)the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the doctor or dentist who is a party to the plan.

Regulation 221

SCHEDULE 15U.K.Requirements for specific products subject to general sale

1.  A medicinal product that contains aloxiprin, aspirin or paracetamol (or, where appropriate, any combination of those substances) and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—U.K.

Column 1Column 2

Effervescent tablets—

(a) that do not contain aspirin, or

(b) that do not contain more than 325 milligrams of aspirin per tablet.

30 tablets

Effervescent tablets—

(a) that contain more than 325 milligrams of aspirin per tablet, but

(b) that do not contain more than 500 milligrams per tablet.

20 tablets

Non-effervescent tablets—

(a) that are enteric-coated,

(b) that contain aspirin only, and

(c) that do not contain more than 75 milligrams per tablet.

28 tablets
Other non-effervescent tablets16 tablets
Powder or granules10 sachets
Capsules16 capsules
Liquid preparations of paracetamol intended for persons aged 12 years and over160 millilitres
Liquid preparations of paracetamol intended for persons aged less than 12 yearsIndividual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses

2.  A medicinal product that contains ibuprofen and that is in the form specified in column 1 of the following table must be presented for sale in a separate and individual package containing not more than the amount of the product specified in the corresponding entry in column 2—U.K.

Form of productMaximum amount
Tablets16 tablets
Capsules16 capsules
Powder or granules12 sachets
Liquid preparations of ibuprofenIndividual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses

Regulations 229, 230, 231,232, 233 and 234

SCHEDULE 16U.K.Patient group directions

PART 1U.K.Particulars to be included in a patient group direction

1.  The period during which the direction is to have effect.U.K.

2.  The description or class of medicinal product to which the direction relates.U.K.

3.  The clinical situations which medicinal products of that description or class may be used to treat or manage in any form.U.K.

4.  Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion and, if so, what restrictions.U.K.

5.  The clinical criteria under which a person is to be eligible for treatment.U.K.

6.  Whether any class of person is excluded from treatment under the direction and, if so, what class of person.U.K.

7.  Whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances.U.K.

8.  The pharmaceutical form or forms in which medicinal products of that description or class are to be administered.U.K.

9.  The strength, or maximum strength, at which medicinal products of that description or class are to be administered.U.K.

10.  The applicable dosage or maximum dosage.U.K.

11.  The route of administration.U.K.

12.  The frequency of administration.U.K.

13.  Any minimum or maximum period of administration applicable to medicinal products of that description or class.U.K.

14.  Whether there are any relevant warnings to note and, if so, what warnings.U.K.

15.  Whether there is any follow up action to be taken in any circumstances and, if so, what action and in what circumstances.U.K.

16.  Arrangements for referral for medical advice.U.K.

17.  Details of the records to be kept of the supply, or the administration, of products under the direction.U.K.

PART 2U.K.Persons on whose behalf a patient group Direction must be signed

Column 1: Class of person by whom product is suppliedColumn 2: Person on whose behalf direction must be signed
Common Services AgencyThe Agency
Health authorityThe health authority
Special health authorityThe special health authority
NHS trust or NHS foundation trustThe trust
[F155Local authority The Chief Executive or Director of Public Health of the local authority]
[F156Public Health England The Chief Executive of Public Health England]
[F156Public Health Agency The Public Health Agency]
F157...F157...

A person who supplies medicinal products pursuant to an arrangement made with—

(a)the Common Services Agency;

(b)a health authority;

(c)a special health authority;

(d)an NHS trust;

[F158(da)[F159an integrated care board];

(db)the National Health Service Commissioning Board;

(dc)a local authority; F160...]

[F161(dd)Public Health England;

(de)Public Health Agency; or]

(e)an NHS foundation trust; F162...

F162(f). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Common Services Agency (where the arrangement has been made with the Agency); otherwise the—

(a)health authority,

(b)special health authority,

(c)NHS trust,

[F163(ca)[F159an integrated care board],

(cb)the National Health Service Commissioning Board,

(cc)a local authority, F164...]

[F165(cd)Chief Executive of Public Health England,

(ce)Public Health Agency, or]

(d)NHS foundation trust, F166...

F166(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

with which the arrangement has been made.

Textual Amendments

F156Words in Sch. 16 Pt. 2 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(a) and words in Sch. 16 Pt. 2 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(a)

F160Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(i)

F161Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(b)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(b)(ii)

F164Word in Sch. 16 Pt. 2 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(i) and word in Sch. 16 Pt. 2 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(i)

F165Words in Sch. 16 Pt. 2 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(2)(c)(ii) and words in Sch. 16 Pt. 2 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(2)(c)(ii)

PART 3U.K.Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed

Column 1: Force or service by whom or on whose behalf the health care is providedColumn 2: Person by whom or on whose behalf direction must be signed
A police force in England and WalesThe chief officer of police for that police force (within the meaning of the Police Act 1996 M7)
A police force in ScotlandThe chief constable of that police force (within the meaning of the Police (Scotland) Act 1967 M8)
The Police Service of Northern IrelandThe Chief Constable of the Police Service of Northern Ireland
The prison service in England and WalesThe governor of the prison in relation to which the health care in question is being provided
The prison service in ScotlandThe Scottish Prison Service Management Board
The prison service in Northern IrelandThe Northern Ireland Prison Service Management Board
Her Majesty's Forces

(a) the Surgeon General,

(b) a Medical Director General, or

(c) a chief executive of an executive agency of the Ministry of Defence

[F167Contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency Medical Director of the contractor carrying out search and rescue operations on behalf of the Maritime and Coastguard Agency]

Textual Amendments

F167Words in Sch. 16 Pt. 3 added (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 7(3) and words in Sch. 16 Pt. 3 added (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 7(3)

Marginal Citations

PART 4U.K.Classes of individuals by whom supplies may be made

  • Pharmacists.

  • Registered chiropodists and podiatrists.

  • Registered dental hygienist.

  • Registered dental therapist.

  • Registered dietitians.

  • Registered midwives.

  • Registered nurses.

  • Registered occupational therapists.

  • Registered optometrists.

  • Registered orthoptists.

  • Registered orthotists and prosthetists.

  • Registered paramedics.

  • Registered physiotherapists.

  • Registered radiographers.

  • Registered speech and language therapists.

Regulations 223(5)(b) and (c) 235,250(5) and 253(5)(d)

SCHEDULE 17U.K.Exemption for sale, supply or administration by certain persons

PART 1U.K.Exemption from restrictions on sale and supply of prescription only medicines

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.1. All prescription only medicines.

1. The sale or supply shall be—

(a) subject to the presentation of an order signed by the principal of an institution concerned with educational research or the appropriate head of department in charge of a specified course of research stating—

(i) the name of the institution for which the prescription only medicine is required, and

(ii) the purpose for which the prescription only medicine is required, and

(iii) the total quantity required; and

(b) for the purpose of the education or research with which the institution is concerned.

2. Persons selling or supplying prescription only medicines to any of the following—

(a) a public analyst appointed under section 27 of the Food Safety Act 1990 M9 or article 27 of the Food Safety (Northern Ireland) Order 1991 M10;

(b) an authorised officer within the meaning of section 5(6) of the Food Safety Act 1990 M11;

(c) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989 M12;

(d) an inspector acting under regulations 325 to 328;

(e) a sampling officer within the meaning of Schedule 31.

2. All prescription only medicines.2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 2006 M13, the National Health Service (Scotland) Act 1978 M14, the National Health Service (Wales) Act 2006 M15 and the Health and Personal Social Services (Northern Ireland) Order 1972 M16, or under any subordinate legislation made under those Acts or that Order.3. All prescription only medicines

3. The sale or supply shall be—

(a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of the prescription only medicine required; and

(b) for the purposes of a scheme referred to in column 1 in this paragraph.

4. Registered midwives.

4. Prescription only medicines containing any of the following substances—

(a) Diclofenac;

(b) Hydrocortisone Acetate;

(c) Miconazole;

(d) Nystatin;

(e) Phytomenadione;

4. The sale or supply shall be only in the course of their professional practice.
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.5. Water for injection.

5. The sale or supply is to a person—

(a) for a purpose other than parenteral administration; or

(b) who has been prescribed dry powder for parenteral administration but has not been prescribed the water for injection that is needed as a diluent.

6. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

6. Items which are—

(a) prescription only medicines which are not for parenteral administration and which—

(i) are eye drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent of Chloramphenicol, or

(ii) are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or

(iii) are prescription only medicines by reason only that they contain any of the following substances—

(aa) Cyclopentolate hydrochloride,

(bb) Fusidic Acid,

(cc) Tropicamide;

(b) the following prescription only medicines—

(i) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight,

(ii) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume,

(iii) Amoxicillin,

(iv) Co-Codamol,

(v) Co-dydramol 10/500 tablets,

(vi) Codeine Phosphate,

(vii) Erythromycin,

(viii) Flucloxacillin,

(ix) Silver Sulfadiazine,

(x) Tioconazole 28%,

(xi) Topical hydrocortisone where the maximum strength of hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.

6. The sale or supply shall be subject to the presentation of an order signed by—

(a) a registered optometrist for a medicine listed under item (a) in column 2;

(b) a registered chiropodist or podiatrist for a medicine listed under item (b) in column 2.

7. Registered optometrists.7. Prescription only medicines listed in item (a) of paragraph 6 column 2.

7. The sale or supply shall be only—

(a) in the course of their professional practice, and

(b) in an emergency.

8. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

8. Medicinal products not for parenteral administration which are prescription only medicines by reason only that they contain any of the following substances—

(a) Acetylcysteine,

(b) Atropine sulphate,

(c) Azelastine hydrochloride,

(d) Diclofenac sodium,

(e) Emedastine,

(f) Homotropine hydrobromide,

(g) Ketotifen,

(h) Levocabastine,

(i) Lodoxamide,

(j) Nedocromil sodium,

(k) Olopatadine,

(l) Pilocarpine hydrochloride,

(m) Pilocarpine nitrate,

(n) Polymyxin B/bacitracin,

(o) Polymyxin B/trimethoprim,

(p) Sodium cromoglycate.

8. The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist.
9. Additional supply optometrists.9. Prescription only medicines specified in paragraph 8 column 2.

9. The sale or supply shall be only—

(a) in the course of their professional practice, and

(b) in an emergency.

10. Holders of [F168UK marketing authorisations, EU marketing authorisations], product licences or manufacturer's licences.10. Prescription only medicines referred to in those authorisations or licences.

10. The sale or supply shall be only—

(a) to a pharmacist,

(b) so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and

(c) of no greater quantity than is reasonably necessary for that purpose.

11. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicine specified in column 2.

11. The following prescription only medicines—

(a) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight,

(b) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume,

(c) Amoxicillin,

(d) Co-Codamol,

(e) Co-dydramol 10/500 tablets,

(f) Codeine Phosphate,

(g) Erythromycin,

(h) Flucloxacillin,

(i) Silver Sulfadiazine,

(j) Tioconazole 28%,

(k) Topical hydrocortisone where the maximum strength of hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.

11. The sale or supply shall be only in the course of their professional practice.
[F16912. Persons selling or supplying prescription only medicines to a school. 12.

[F170Prescription only medicines comprising:

(a)

an inhaler containing salbutamol; or

(b)

an auto-injector containing adrenaline]

12. The sale or supply shall be—

(a) subject to the presentation of an order signed by the principal or head teacher at the school concerned stating—

(i) the name of the school for which the medicinal product is required,

(ii) the purpose for which that product is required, and

(iii) the total quantity required, and

(b) for the purpose of supplying [F171or administering] the medicinal product to pupils at the school in an emergency.]

[F17213 Registered orthoptists [F173against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2].

13 The following prescription only medicines–

(a) Atropine,

(b) Cyclopentolate,

(c) Tropicamide,

(d) Lidocaine with fluorescein,

(e) Oxybuprocaine,

(f) Proxymetacaine,

(g) Tetracaine,

(h) Chloramphenicol,

(i) Fusidic acid.

13 The sale or supply shall be only in the course of their professional practice.]

Textual Amendments

F170Words in Sch. 17 Pt. 1 substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(a)(i) and words in Sch. 17 Pt. 1 substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(a)(i)

F171Words in Sch. 17 Pt. 1 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(a)(ii) and words in Sch. 17 Pt. 1 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(a)(ii)

F172Words in Sch. 17 Pt. 1 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(2) and words in Sch. 17 Pt. 1 inserted (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(2)

F173Words in Sch. 17 Pt. 1 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(b) and words in Sch. 17 Pt. 1 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(b)

Marginal Citations

M91990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

M101991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

M121989 No. 846 (N.I. 6).

PART 2U.K.Exemption from the restriction on supply of prescription only medicines

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.1. All prescription only medicines1. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the exercise of the functions of the Institution.
2. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.2. All prescription only medicines.2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 M17 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002 M18 to supply a controlled drug.3. Such prescription only medicines, being controlled drugs, as are specified in the licence.3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
4. Persons employed or engaged in the provision of lawful drug treatment services.4. Ampoules of sterile water for injection that contain no more than 2ml of water each.4. The supply shall be only in the course of provisions of lawful drug treatment services.

[F1744a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies–

(a) an NHS body;

(b) a local authority;

(c) Public Health England; or

(d) Public Health Agency.

4a A prescription only medicine F175... containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only.4a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency.]
5. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.5. Such prescription only medicines as may be specified in the relevant enactment.

5. The supply shall be—

(a) for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and

(b) subject to such conditions and such circumstances as may be specified in the relevant enactment.

6. Persons operating an occupational health scheme.6. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.

6. The supply of the prescription only medicine shall be—

(a) in the course of operating an occupational health scheme, and

(b) made by—

(i) a doctor, or

(ii) a registered nurse acting in accordance with the written directions of a doctor as to the circumstance in which such medicines are to be used in the course of an occupational health scheme.

[F1766a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them. 6b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 6a in response to an order in writing signed by a doctor or an occupational health vaccinator.6c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 6a and is made, if not by a doctor, by an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used.]
7. The operator or commander of an aircraft.7. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to an operator or commander of an aircraft in response to an order in writing signed by a doctor.7. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
8. Persons employed as qualified first-aid personnel on off-shore installations.8. All prescription only medicines.8. The supply shall be only so far as is necessary for the treatment of persons on the installation.
9. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.9. Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor.9. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.
10. Persons (“P”) who are members of Her Majesty's armed forces.10. All prescription only medicines.

10. The supply shall be—

(a) in the course of P undertaking any function as a member of Her Majesty's armed forces; and

(b) where P is satisfied that it is not practicable for another person who is legally entitled to supply a prescription only medicine to do so; and

(c) only in so far as is necessary—

(i) for the treatment of a sick or injured person in a medical emergency, or

(ii) to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not supplied.

[F17711. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. 11. A prescription only medicinal product comprising an inhaler containing salbutamol.

11. The supply shall be—

(a) in the course of P carrying on the business of a school;

(b) where supply is to a pupil at that school who is known to suffer from asthma; and

(c) where the pupil requires the medicinal product in an emergency.]

[F17812 Registered midwives.

12 Prescription only medicines for parenteral administration that contain–

(a) Diamorphine,

(b) Morphine,

(c) Pethidine hydrochloride.

12 The supply shall be only in the course of their professional practice.]

Textual Amendments

F174Words in Sch. 17 Pt. 2 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(2) and words in Sch. 17 Pt. 2 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(2)

F175Words in Sch. 17 Pt. 2 omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 18(a) and words in Sch. 17 Pt. 2 omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 18(a)

F178Words in Sch. 17 Pt. 2 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(3) and words in Sch. 17 Pt. 2 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(3)

Marginal Citations

M17S.I. 2001/3998, to which there are amendments that are not relevant.

M18S.R. 2002 No. 1, to which there are amendments that are not relevant.

PART 3U.K.Exemptions from the restriction on administration of prescription only medicines

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.

1. Prescription only medicines for parenteral administration that contain—

(a) Adrenaline,

(b) Bupivacaine hydrochloride,

(c) Bupivacaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride,

(d) Levobupivacaine hydrochloride,

(e) Lidocaine hydrochloride,

(f) Lidocaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride,

(g) Mepivacaine hydrochloride,

(h) Methylprednisolone,

(i) Prilocaine hydrochloride,

(j) Ropivacaine hydrochloride.

1. The administration shall only be in the course of their professional practice and where the medicine includes a combination of substances in column 2, those substances shall not have been combined by the chiropodist or podiatrist.
2. Registered midwives and student midwives.

2. Prescription only medicines for parenteral administration containing any of the following substances but no other substance that is classified as a product available on prescription only—

(a) Adrenaline,

(b) Anti-D immunoglobulin,

(c) Carboprost,

(d) Cyclizine lactate,

(e) Diamorphine,

(f) Ergometrine maleate,

(g) Gelofusine,

(h) Hartmann's solution,

(i) Hepatitis B vaccine,

(j) Hepatitis immunoglobulin,

(k) Lidocaine hydrochloride,

(l) Morphine,

(m) Naloxone hydrochloride,

(n) Oxytocins, natural and synthetic,

(o) Pethidine hydrochloride,

(p) Phytomenadione,

(q) Prochloperazine,

(r) Sodium chloride 0.9%.

2. The medicine shall—

(a) in the case of Lidocaine and Lidocaine hydrochloride, be administered only while attending on a woman in childbirth, and

(b) where administration is—

(i) by a registered midwife, be administered in the course of their professional practice;

(ii) by a student midwife—

(aa) be administered under the direct supervision of a registered midwife; and

(bb) not include Diamorphine, Morphine or Pethidine hydrochloride.

3. Persons who are authorised as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations 2001 M19 or, regulations 8(3) or 9(3) of the Misuse of Drugs Regulations (Northern Ireland) 2002 M20, to supply a controlled drug by way of administration only.3. Prescription only medicines that are specified in the group authority.3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.4. All prescription only medicines that are for parenteral administration.4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.5. Prescription only medicines that are for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.

5. The prescription only is administered in the course of an occupational health scheme, and the individual administering the medicine is—

(a) a doctor, or

(b) a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used.

[F1795a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them. 5b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 5a in response to an order in writing signed by a doctor or an occupational health vaccinator.5c. The administration of the medicine is in the course of an occupational health scheme mentioned in entry 5a, and the individual administering the medicine is, if not a doctor, an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used.]
6. The operator or commander of an aircraft.6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of the doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on off-shore installations.7. All prescription only medicines that are for parenteral administration.7. The administration shall be only so far as is necessary for the treatment of persons on the installation.
8. Persons who are registered paramedics.

8. The following prescription only medicines for parenteral administration—

(a) Diazepam 5 mg per ml emulsion for injection,

(b) Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion,

(c) medicines containing the substance Ergometrine Maleate 500 mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient,

(d) prescription only medicines containing one or more of the following substances, but no other active ingredient—

(i) Adrenaline Acid Tartrate,

(ii) Adrenaline hydrochloride,

(iii) Amiodarone,

(iv) Anhydrous glucose,

(v) Benzlypenicillin,

(vi) Compound Sodium Lactate Intravenous Infusion (Hartmann's Solution),

(vii) Ergometrine Maleate,

(viii) Furosemide,

(ix) Glucose,

(x) Heparin Sodium,

(xi) Lidocaine Hydrochloride,

(xii) Metoclopramide,

(xiii) Morphine Sulphate,

(xiv) Nalbuphine Hydrochloride,

(xv) Naloxone Hydrochloride,

(xvi) Ondansetron

(xvii) Paracetamol,

(xviii) Reteplase,

(xix) Sodium Chloride,

(xx) Streptokinase,

(xxi) Tenecteplase.

8. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.
9. Persons who hold the advanced life support provider certificate issued by the Resuscitation Council (UK).

9. The following prescription only medicines for parenteral administration —

(a) Adrenaline 1:10,000 up to I mg; and

(b) Amiodarone.

9. The administration shall be only in an emergency involving cardiac arrest, and in the case of adrenaline the administration shall be intravenous only.
[F18010. Persons (“P”) who are members of Her Majesty’s armed forces.10. All prescription only medicines.

10. The administration shall be—

(a)

in the course of P undertaking any function as a member of Her Majesty’s armed forces; and

(b)

where P is satisfied that it is not practicable for another person who is legally entitled to administer a prescription only medicine to do so; and

(c)

only in so far as is necessary—

(i)

for the treatment of a sick or injured person in an emergency, or

(ii)

to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not administered.]

[F18111 A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. 11 A prescription only medicine comprising an auto-injector containing adrenaline.

11 The administration shall be—

(a) in the course of P carrying on the business of a school;

(b) where administration is to a pupil at that school who is known to be at risk of anaphylaxis; and

(c) where the pupil requires the medicinal product in an emergency.]

Textual Amendments

F180Words in Sch. 17 Pt. 3 added (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 11 and words in Sch. 17 Pt. 3 added (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 11

F181Words in Sch. 17 Pt. 3 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(3) and words in Sch. 17 Pt. 3 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(3)

Marginal Citations

M19S.I. 2001/3998 as amended by S.I. 2007/2154. There are other amendments that are not relevant.

M20S.R. 2002 No. 1, as amended by S.R. 2007 No. 348. There are other amendments that are not relevant.

PART 4U.K.Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products

Column 1Column 2Column 3
Persons exemptedMedicinal products to which exemption appliesConditions
1. Registered chiropodists and podiatrists.

1. Medicinal products on a general sale list which are for external use and are not veterinary drugs and the following pharmacy medicines for external use—

(a) Potassium permanganate crystals or solution;

(b) ointment of heparinoid and hyaluronidase; and

(c) products containing, as their only active ingredients, any of the following substances, at a strength, in the case of each substance, not exceeding that specified in relation to that substance—

(i) 9.0 per cent Borotannic complex

(ii) 10.0 per cent Buclosamide

(iii) 3.0 per cent Chlorquinaldol

(iv) 1.0 per cent Clotrimazole

(v) 10.0 per cent Crotamiton

(vi) 5.0 per cent Diamthazole hydrochloride

(vii) 1.0 per cent Econazole nitrate

(viii) 1.0 per cent Fenticlor

(ix) 10.0 per cent Glutaraldehyde

(x) 1.0 per cent Griseofulvin

(xi) 0.4 per cent Hydrargaphen

(xii) 2.0 per cent Mepyramine maleate

(xiii) 2.0 per cent Miconazole nitrate

(xiv) 2.0 per cent Phenoxypropan-2-ol

(xv) 20.0 per cent Podophyllum resin

(xvi) 10.0 per cent Polynoxylin

(xvii) 70.0 per cent Pyrogallol

(xviii) 70.0 per cent Salicylic acid

(xix) 1.0 per cent Terbinafine

(xx) 0.1 per cent Thiomersal.

2. Registered chiropodists and podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines in column 2.

2. (a) The following prescription only medicines—

(i) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight,

(ii) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in the lacquer does not exceed 5 per cent by weight in volume,

(iii) Amoxicillin,

(iv) Co-Codamol,

(v) Co-dydramol 10/500 tablets,

(vi) Codeine Phosphate,

(vii) Erythromycin,

(viii) Flucloxacillin,

(ix) Silver Sulfadiazine,

(x) Tioconazole 28%,

(xi) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight; and

2. The sale or supply shall be only in the course of their professional practice, and the medicinal product must have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied.
(b) Ibuprofen, other than preparations of ibuprofen which are prescription only medicines.
3. Registered optometrists.

3. All medical products on a general sale list, all pharmacy medicines and prescription only medicines which are not for parenteral administration and which—

(a) are eye drops and are prescription only medicines by reason only that they contain not more than—

(i) 30.0 per cent Sulphacetamide Sodium, or

(ii) 0.5 per cent Chloramphenicol, or

(b) are eye ointments and are prescription only medicines by reason only that they contain not more than—

(i) 30.0 per cent Sulphacetamide Sodium, or

(ii) 1.0 per cent Chloramphenicol, or

(c) are prescription only medicines by reason only that they contain any of the following substances—

(i) Cyclopentolate hydrochloride,

(ii) Fusidic acid,

(iii) Tropicamide.

3. The sale or supply shall be only—

(a) in the case of medicinal products on a general sale list and pharmacy medicines, in the course of their professional practice;

(b) in the case of prescription only medicines, in the course of their professional practice and in an emergency.

4. Additional supply optometrists.

4. Medicinal products which are prescription only medicines by reason only that they contain any of the following substances—

(a) Acetylcysteine,

(b) Atropine sulphate,

(c) Azelastine hydrochloride,

(d) Diclofenac sodium,

(e) Emedastine,

(f) Homotropine hydrobromide,

(g) Ketotifen,

(h) Levocabastine,

(i) Lodoximide,

(j) Nedocromil sodium,

(k) Olopatadine,

(l) Pilocarpine hydrochloride,

(m) Pilocarpine nitrate,

(n) Polymyxin B/bacitracin,

(o) Polymyxin B/trimethoprim,

(p) Sodium Cromoglycate.

4. The sale or supply shall be only in the course of their professional practice and only in an emergency.
5. Holders of manufacturer's licences where the licence in question contains a provision that the licence holder shall manufacture the medicinal product to which the licence relates only for a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgement as to the treatment required.

5. Medicinal products on a general sale list which are for external use and are not veterinary drugs and pharmacy medicines which are for external use in the treatment of hair and scalp conditions and which contain any of the following—

(a) not more than 5.0 per cent of Boric acid,

(b) Isopropyl myristate or Lauryl sulphate,

(c) not more than 0.004 per cent Oestrogens,

(d) not more than 1.0 per cent of Resorcinol,

(e) not more than 3.0 per cent of Salicylic acid,

(f) not more than 0.2 per cent of Sodium pyrithione.

5. The licence holder shall sell or supply the medicinal product in question only to a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgement as to the treatment required.
6. Persons selling or supplying medicinal products to universities, other institutions concerned with higher education or institutions concerned with research.6. All medicinal products.

6. The sale or supply shall be—

(a) Subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of the specified course of research stating—

(i) the name of the institution for which the medicinal product is required,

(ii) the purpose for which the medicinal product is required, and

(iii) the total quantity required, and

(b) for the purposes of the education or research with which the institution is concerned.

7. Persons selling or supplying medicinal products to organisations for research purposes.7. All medicinal products.

7. The sale or supply is only for the purposes of research and shall be—

(a) subject to the presentation of an order signed by the representative of the organisation concerned stating—

(i) who requires the medicine,

(ii) the purposes for which it is required,

(iii) the quantity required, and

(iv) the purposes of the research with which the organisation is concerned; and

(b) not for administration to humans.

8. Persons selling or supplying medicinal products to any of the following—

(a) a public analyst appointed under section 27 of the Food Safety Act 1990 or under article 27 of the Food Safety (Northern Ireland) Order 1991;

(b) an agricultural analyst appointed under section 67 of the Agriculture Act 1970 M21,

(c) a person duly authorised by an enforcement authority under regulations 325 to 328,

(d) a sampling officer within the meaning a sampling officer within the meaning of Schedule 31.

8. All medicinal products.

8. The sale or supply is in connection with the exercise of any statutory function carried out by any person listed in sub-paragraphs (a) to (d) of column 1 provided that—

(a) the medicinal products are requested on an order signed by or on behalf of a person listed in sub-paragraph (a) to (d) of column 1, and

(b) the order gives—

(i) the status of the person signing it,

(ii) the amount of medicinal product required.

9. Holders of a [F182UK marketing authorisation, EU marketing authorisation], a certificate of registration or a manufacturer's licence.9. Medicinal product referred to in the [F182UK marketing authorisation, EU marketing authorisation], certificate of registration or manufacturer's licence.

The sale or supply shall be only—

(a) to a pharmacist,

(b) so as to enable that pharmacist to prepare an entry relating to the medical product in question in a tablet or capsule identification guide or similar publication, and

(c) of no greater quantity than is reasonably necessary for that purpose.

10. Registered dispensing opticians.

10. Pharmacy medicines for external use containing chloramphenicol at a strength not exceeding—

(a) 0.5 per cent in eye drops;

(b) 1 per cent in ointment.

10. The sale or supply shall only be in the course of their professional practice.
[F18311. Operator or commander of an aircraft.11. All medicinal products on a general sale list.

11. The medicinal product must—

(a)

have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied; and

(b)

be stored in a part of the aircraft which the operator is able to close so as to exclude the public.]

[F18312. The operator of a train.12. All medicinal products on a general sale list.

12. The medicinal product must—

(a)

have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied; and

(b)

be stored in a part of the train which the operator is able to close so as to exclude the public.]

[F18413 Registered orthoptists [F185against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2].

13 All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines–

(a) Atropine,

(b) Cyclopentolate,

(c) Tropicamide,

(d) Lidocaine with fluorescein,

(e) Oxybuprocaine,

(f) Proxymetacaine,

(g) Tetracaine,

(h) Chloramphenicol,

(i) Fusidic acid.

13 The sale or supply shall be only in the course of their professional practice.]

Textual Amendments

F183Sch. 17 Pt. 4 Table Item 11, 12 inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 9

F184Words in Sch. 17 Pt. 4 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(4) and words in Sch. 17 Pt. 4 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(4)

F185Words in Sch. 17 Pt. 4 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(4) and words in Sch. 17 Pt. 4 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(4)

Marginal Citations

M211970 c.40: subsection (1) was amended by section 272(1) of and Schedule 30 to the Local Government Act 1972; section 16 of and Schedule 8 paragraph 15 to the Local Government Act 1985, and section 66(6) and (8) of, and Schedule 16 paragraph 38(5) and Schedule 18 to the Local Government (Wales) Act 1994. Subsection (1A) was inserted by section 66(6) of and Schedule 16 paragraph 38(5) to that Act. Subsection 2 was substituted by section 180(1) of and Schedule 13 paragraph 85(2) to the Local Government etc (Scotland) Act 1994, and subsection (7) was repealed by sections 1(1) and 194 of, and Schedule 1 paragraph 8 and Schedule 34 Part 1 to the Local Government, Planning and Land Act 1980.

PART 5U.K.Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products

Column 1Column 2Column 3
Persons exemptedMedicinal products to which exemption appliesConditions
1. Royal National Lifeboat Institution and certificated first aiders of the Institution.1. All medicinal products.1. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
2. British Red Cross Society and certificated first aid and certificated nursing members of the Society.2. All pharmacy medicines and all medicinal products on a general sale list.2. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
3. St John Ambulance Association and Brigade and certificated first aid and certificated nursing members of the Association and Brigade.3. All pharmacy medicines and all medicinal products on a general sale list.3. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
4. St. Andrew's Ambulance Association and certificated first aid and certificated nursing members of the Association.4. All pharmacy medicines and all medicinal products on a general sale list.4. The supply shall be only so far as is necessary for the treatment of sick and injured persons.
5. Order of Malta Ambulance Corps and certificated first aid and certificated nursing members of the Corps.5. All pharmacy medicines and all medicinal products on a general sale list.5. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
6. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.6. Such prescription only medicines and such pharmacy medicines as are specified in the licence.6. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
7. Persons employed or engaged in the provision of lawful drug treatment services.7. Ampoules of sterile water for injection that contain no more than 5ml of water each.7. The supply shall be only in the course of provision of lawful drug treatment services.

[F1867a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies–

(a) an NHS body;

(d) a local authority;

(c) Public Health England; or

(d) Public Health Agency.

7a [F187A medicinal product containing naloxone hydrochloride but no other substance that is classified as a product available only on prescription or as a product available only from a pharmacy.]7a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency.]
8. Persons requiring medicinal products for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.8. Such prescription only medicines and such pharmacy medicines as may be specified in the relevant enactment and medicinal products on a general sale list.

8. The supply shall be—

(a) for the purpose of enabling compliance with any requirement made by or in pursuance of any such enactment, and

(b) subject to such conditions and in such circumstances as may be specified in the relevant enactment.

9. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.9. All medicinal products.9. The supply shall be only so far as is necessary for the treatment of persons on the ship.
10. Persons operating an occupational health scheme.10. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines as are sold or supplied to a person operating an occupational health scheme in response to an order signed by a doctor or a registered nurse.

10. (a) The supply shall be in the course of an occupational health scheme.

(b) The individual supplying the medicinal product, if not a doctor, shall be—

(i) a registered nurse, and

(ii) where the medicinal product in question is a prescription only medicine, acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of an occupational health scheme.

[F18810a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them. 10b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 10a in response to an order in writing signed by a doctor or an occupational health vaccinator.10c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 10a, and the individual supplying the medicine is, if not a doctor, an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used.]
11. Persons carrying on the business of a school providing full-time education.11. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.

11. The supply shall be—

(a) in the course of a school dental scheme, and

(b) if to a child under 16 only where the parent or guardian of that child has consented to such supply.

12. Health authorities or Primary Health Trusts.12. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.

12. The supply shall be in the course of—

(a) a pre-school dental scheme, and the individual supplying the medicinal product shall be a registered nurse, or

(b) a school dental scheme, and if to a child under 16 only where the parent or guardian of that child has consented to such supply.

13. The operator or commander of an aircraft.13. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of an aircraft in response to an order in writing signed by a doctor.13. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and, in the case of a prescription only medicine, shall be in accordance with the written instructions of a doctor as to the circumstances in which the prescription only medicines of the description in question are to be used on the aircraft.
14. Persons employed as qualified first-aid personnel on offshore installations.14. All medicinal products.14. The supply shall be only so far as is necessary for the treatment of persons on the installation.
15. A prison officer.15. All medicinal products on the general sale list.15. The supply shall only be so far as is necessary for the treatment of prisoners.
16. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.16. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are sold or supplied to a person specified in column 1 of this paragraph in response to an order in writing signed by a doctor.16. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.
17. Her Majesty's armed forces.17. All medicinal products.17. The supply shall be only so far as is necessary for the treatment of a sick or injured person or the prevention of ill-health.
[F18918. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. 18. A prescription only medicinal product comprising an inhaler containing salbutamol.

18. The supply shall be—

(a) in the course of P carrying on the business of a school;

(b) where supply is to a pupil at that school who is known to suffer from asthma; and

(c) where the pupil requires the medicinal product in an emergency.]

[F19019. Persons supplying medicinal products under an off-site emergency plan prepared under the [F191Radiation (Emergency Preparedness and Public Information) Regulations 2019].]

[F19019. Pharmacy medicines which contain any of the following substances but no other active ingredient—

(a) Potassium Iodide;

(b) Potassium Iodate.]

[F19019. The supply shall be—

(a) in accordance with the off-site emergency plan; and

(b) only in the event that a radiation emergency has occurred or an event has occurred which could reasonably be expected to lead to a radiation emergency.]

[F19020. A person or body listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies Act 2004.]

[F19020. Pharmacy medicines which contain any of the following substances but no other active ingredient—

(a) Potassium Iodide;

(b) Potassium Iodate.]

[F19020. The supply shall only be in response to the occurrence, or likely occurrence, of one of the following events—

(a) an emergency within the meaning of section 1 of the Civil Contingencies Act 2004;

(b) a [F192radiation] emergency within the meaning of regulation 24 of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009.]

Textual Amendments

F186Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(3) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(3)

F187Words in Sch. 17 Pt. 5 substituted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 18(b) and words in Sch. 17 Pt. 5 substituted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 18(b)

F190 Words in Sch. 17 Pt. 5 inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 12(2) and words in Sch. 17 Pt. 5 inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 12(2)

Regulation 225

SCHEDULE 18U.K.Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225

  • Ammonium bromide

  • Calcium bromide

  • Calcium bromidolactobionate

  • Embutramide

  • Fencamfamin hydrochloride

  • Fluanisone

  • Hexobarbitone

  • Hexobarbitone sodium

  • Hydrobromic acid

  • Meclofenoxate hydrochloride

  • Methohexitone sodium

  • Pemoline

  • Piracetam

  • Potassium bromide

  • Prolintane hydrochloride

  • Sodium bromide

  • Strychnine hydrochloride

  • Tacrine hydrochloride

  • Thiopentone sodium

Regulation 238

SCHEDULE 19U.K.Medicinal products for parenteral administration in an emergency

  • Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis

  • Atropine sulphate and obidoxime chloride injection

  • Atropine sulphate and pralidoxime chloride injection

  • Atropine sulphate injection

  • Atropine sulphate, pralidoxime mesilate and avizafone injection

  • Chlorphenamine injection

  • Dicobalt edetate injection

  • Glucagon injection

  • Glucose injection

  • Hydrocortisone injection

  • Naloxone hydrochloride

  • Pralidoxime chloride injection

  • Pralidoxime mesilate injection

  • Promethazine hydrochloride injection

  • Snake venom antiserum

  • Sodium nitrite injection

  • Sodium thiosulphate injection

  • Sterile pralidoxime

Regulation 241

SCHEDULE 20U.K.Herbal medicinal products specified for the purposes of regulation 241

PART 1U.K.

Botanical SourceCommon Name
Apocynum cannabinumCanadian hemp
Areca catechuAreca
Artemisia cinaSantonica
Brayera anthelminticaKousso
Catha edulisCatha
Chenopodium ambrosioides var anthelminticumChenopodium
Crotalaria berberoanaCrotalaria fulva
Crotalaria spectabilisCrotalaria spect.
Cucurbita maximaCucurbita
Delphinium staphisagriaStavesacre seeds
Dryopteris filix-masMale fern

Duboisia leichardtii

Duboisia myoporoides

Duboisia
Ecballium elateriumElaterium

Embelia ribes

Embelia robusta

Embelia
Erysimum canescensErysimum
Holarrhena antidysentericaHolarrhena
Juniperus sabinaSavin
Mallotus philippinensisKamala
Pausinystalia yohimbeYohimbe bark
Punica granatumPomegranate bark
Rhus radicansPoison ivy

Scopolia carniolica

Scopolia japonica

Scopolia

Strophanthus courmonti

Strophanthus emini

Strophanthus gratus

Strophanthus hispidus

Strophanthus kombe

Strophanthus nicholsoni

Strophanthus sarmentosus

Strophanthus

Ulmus fulva

Ulmus rubra

Slippery elm bark (whole or unpowdered)
Viscum albumMisletoe berry

PART 2U.K.

Column 1Column 2Column 3
Substance
Botanical SourceCommon NameMaximum dose and maximum daily dosePercentage

Aconitum balfourni

Aconitum chasmanthum Aconitum deinorrhizum

Aconitum lycoctonum Aconitum napellus

Aconitum spicatum

Aconitum stoerkianum Aconitum uncinatum var japonicum

Aconite1.3 per cent
Adonis vernalisAdonis vernalis

100 mg (MD)

300mg (MDD)

Aspidosperma quebrachoblancoQuebracho

50 mg (MD)

150 mg (MDD)

Atropa acuminata

Atropa belladonna

Belladonna herb, belladonna root

In the form of belladonna herb:

50 mg (MD)

150 mg (MDD);

In the form of belladonna root:

30 mg (MD)

90 mg (MDD)

Chelidonium majusCelandine

2 g (MD)

6 g (MDD)

Cinchona calisaya

Cinchona ledgerana Cinchona micrantha

Cinchona officinalis

Cinchona succirubra

Cinchona bark

250 mg (MD)

750 mg (MDD)

Colchicum autumnaleColchicum corm

100 mg (MD)

300 mg (MDD)

Conium maculatumConium fruits, conium leaf7.0 per cent
Convallaria majalisConvallaria

150 mg (MD)

450 mg (MDD)

Datura innoxia

Datura stramonium

Stramonium

50 mg (MD)

150 mg (MDD)

Ephedra distachya

Ephedra equisetina

Ephedra gerardiana

Ephedra intermedia

Ephedra sinica

Ephedra

600 mg (MD)

1800 mg (MDD)

Gelsemium sempervirensGelsemium

25 mg (MD)

75 mg (MDD)

Hyoscyamus albus

Hyoscyamus muticus Hyoscyamus niger

Hyoscyamus

100mg (MD)

300 mg (MDD)

Lobelia inflataLobelia

200 mg (MD)

600 mg (MDD)

Pilocarpus jaborandi

Pilocarpus microphyllus

Jaborandi5.0 per cent
Rhus toxicodendronPoison oak10.0 per cent
Senecio jacobaeaRagwort10.0 per cent

Regulation 242

SCHEDULE 21U.K.Medicinal products at high dilutions

PART 1U.K.Dilutions of unit preparations diluted to at least one part in a thousand (3x)

  • Agaricus muscarius

  • Ailanthus glandulosa

  • Apocynum cannabinum

  • Aurum lodatum

  • Belladonna

  • Bismuth Subgallate

  • Bryonia alba dioica

  • Calcium Fluoride

  • Cantharis

  • Cerium oxalicum

  • Chelidonium majus

  • Chenopodium oil

  • Cina

  • Colocynthis

  • Convallaria majalis

  • Gelsemium sempervirens

  • Hyoscyamus niger

  • Lycopodium

  • Manganese acetate

  • Ranunculus bulbosus

  • Terebinthinae oleum

PART 2U.K.Dilutions of unit preparations diluted to at least one part in a million (6x)

  • Adonis vernalis

  • Agaricus bulbosus

  • Agaricus muscarius

  • Agnus castus

  • Ailanthus glandulosa

  • Alum

  • Amethyst

  • Ammonium Iodide

  • Amygdalae amarae

  • Apatite

  • Apocynum androsaemifolium

  • Apocynum cannabinum

  • Argentite

  • Argentum Chloride

  • Argentum Iodide

  • Arnica

  • Artemisia cina

  • Aspidium filix-mas

  • Aspidium anthelmintica

  • Aurum Sulphide

  • Balsamum copivae

  • Balsamum peruvianum

  • Barium Citrate

  • Barium Citrate

  • Barium Sulphate

  • Bismuth Metal

  • Bismuth Subgallate

  • Bismuth Subnitrate

  • Boletus laricis

  • Bovista

  • Cade Oil

  • Calcium Fluoride

  • Cantharis

  • Carduus marianus

  • Cedar Wood Oil

  • Cerium Oxalicum

  • Chalcocite

  • Chalcopyrite

  • Chelidonium majus

  • Chenopodium Oil

  • Colocynthis

  • Convallaria majalis

  • Copper Silicate, Nat.

  • Crotalus horridus

  • Cucurbita

  • Cucumis melo

  • Datura Stramonium

  • Derris

  • Diamond

  • Ephedra vulgaris

  • Ferric Acetate

  • Ferrous Iodide

  • Ferrous Oxalate

  • Ferrous Sulphide

  • Formic Acid

  • Gall

  • Gelsemium sempervirens

  • Gneiss

  • Granatum ( Pomegranate) Bark

  • Harmamelis Virginiana

  • Hepar Sulfuris

  • Hyoscyamus niger

  • Iris florentine

  • Jaborandi

  • Juniperus sabina

  • Kalinite

  • Lachmanthus tinctoria

  • Lapis Albus

  • Lycopodium

  • Magnesium

  • Magnesium Acetate

  • Magnesium Chloride

  • Magnetite

  • Manganese Acetate

  • Nicotiana tabacum

  • Nicotiana tabacum oil

  • Oleander

  • Opuntia vulgaris

  • Oxalic Acid

  • Petroleum

  • Phellandrium aquaticum

  • Pix Liquida

  • Platinum

  • Platinum Chloride

  • Potassium Hydroxide

  • Potassium Silicate

  • Pyrethrum

  • Pyrolusite

  • Ranunculus acris

  • Ranunculus bulbosus

  • Ranunculus flammula

  • Ranunculus repens

  • Ranunculus sceleratus

  • Rhodium Oxynitrate

  • Rhododendron chrysanthemum

  • Rhus toxicodendron

  • Salicylic Acid

  • Scrophularia aquatica

  • Sodium Aluminium Chloride

  • Sodium Auro-chloride

  • Sodium Hypochlorite

  • Sodium Nitrate

  • Squill

  • Stannum Metal

  • Staphisagria

  • Sulphur Iodide

  • Tamus communis

  • Tannic Acid

  • Terebinthinae Oleum

  • Theridion

  • Thuja occidentalis

  • Topaz

  • Uric Acid

  • Zinc Hypophosphite

  • Zinc Isovalerate

PART 3U.K.Dilutions of unit preparations diluted to at least one part in ten (1x)

  • Abies excelsa

  • Abies nigra

  • Abies nobilis

  • Acalpha indica

  • Agate

  • Alisma plantago Aq.

  • Alstonia scholaris

  • Aluminium

  • Amber (Succinum)

  • Ambra grisea

  • Ammonium Phosphate

  • Angostura vera

  • Anthoxanthum

  • Apis mellifera

  • Aqua Marina

  • Aqua Mellis

  • Aralia racemosa

  • Aranea diadema

  • Arum maculatum

  • Arum triphyllum

  • Asarum

  • Asperula odorata

  • Astacus fluviatillis

  • Auric Chloride

  • Badiaga

  • Beech (fagus sylvestris)

  • Bellis perennis

  • Berberis aquifolium

  • Borago officinalis

  • Butyric Acid

  • Calcium Metal

  • Calcium Chloride

  • Calcium Oxide

  • Calcium Sulphate

  • Castoreum

  • Ceanothus americanus

  • Cedron

  • Cerato (Ceratostigma Willmottiana)

  • Cherry Plum (Prunus cerasifera)

  • Chestnut, Red and Sweet

  • Cholesterinum

  • Chrysolite

  • Cistus canadensis

  • Clematis erecta

  • Conchae vera

  • Conchiolinum

  • Corallium Rubrum

  • Crab Apple

  • Crocus sativus

  • Erbium

  • Erigeron Canadense

  • Fuligo

  • Genista tinctoria

  • Geum urbanum

  • Glycogen

  • Gnaphalium leontopodium

  • Gold

  • Gorse (Ulex europaeus)

  • Graphites

  • Gratiola officinalis

  • Gymnocladus (American Coffee Tree)

  • Haematoxylon Campechianum

  • Hecla Lava (Ash from Mount Hecla)

  • Hedeoma pulegioides

  • Hedra helix

  • Heliotrope

  • Heracleum spondylium

  • Herniaria

  • Hornbeam (Carpinus betulus)

  • Iberis amara

  • Impatiens

  • Iris germanica

  • Iris pseudacorus

  • Jacaranda procera

  • Jatropha curcas

  • Juncus communis

  • Justica adhatoda

  • Lamium album

  • Laurus nobilis oil

  • Laurocerasus

  • Ledum palustre

  • Lilium tigrinum

  • Lonicera caprifolium

  • Lysimachia vulgaris

  • Magnesium Phosphate

  • Magnesite

  • Magnolia

  • Marum verum

  • Melilotus officinalis

  • Menispermum canadense

  • Pephitis putorius

  • Mercurialis perennis

  • Mimulus (Mimullis guttatus)

  • Moschus

  • Myrica gale

  • Myrtus communis

  • Ocimum basilicum

  • Olive

  • Oxalis acetosella

  • Pangamic Acid

  • Paullinia cupana

  • Penthorum sedoides

  • Pollen (mixed)

  • Polygonatum multiflorum

  • Polygonum aviculare

  • Polypodium vulgare

  • Primula vulgaris

  • Prunella vulgaris

  • Ptellea trifoliata

  • Ratanhia

  • Robinia pseudoacacia

  • Rubia tinctorum

  • Rumex acetosella

  • Sal Marina

  • Sarcolactic Acid

  • Sarracenia purpurea

  • Scleranthus (Scleranthus annuus)

  • Silica

  • Silphium laciniathum

  • Sodium Benzoate

  • Spongia marina

  • Star of Bethlehem (Ornithogalum umbellatum)

  • Ulmus campestris

  • Vine

  • Walnut (juglerus regia)

  • Water Violet (Hottonia palustris)

  • Wild Oat

  • Wild Rose

PART 4U.K.Dilutions of unit preparations diluted to at least one part in ten (1x) for external use

  • Adonis vernalis

  • Agricus bulbosus

  • Agricus muscarius

  • Agnus castus

  • Allanthus glandulosa

  • Alum

  • Amethyst

  • Ammonium Iodide

  • Amygdalae amarae

  • Apatite

  • Apocynum androsaemifolium

  • Apocynum cannabinum

  • Argentite

  • Argentum Chloride

  • Argentum Iodide

  • Artemisia cina

  • Aspidium filix-mas

  • Aspidium anthelmintica

  • Aurum Sulphide

  • Balsamum copaivae

  • Balsamum peruvianum

  • Barium Citrate

  • Barium Sulphate

  • Bismuth Metal

  • Bismuth Subgallate

  • Bismuth Subnitrate

  • Boletus laricis

  • Bovista

  • Cade Oil

  • Calcium Fluoride

  • Carduus marianus

  • Cedar Wood Oil

  • Cerium Oxalicum

  • Chalcocite

  • Chalcopyrite

  • Chelidonium majus

  • Chenopodium Oil

  • Colocynthis

  • Convallaria majalis

  • Copper Silicate, Nat

  • Crotalus horridus

  • Cucurbita

  • Cucumis melo

  • Datura stramonium

  • Derris

  • Diamond

  • Ephedra vulgaris

  • Ferric Acetate

  • Ferrous Iodide

  • Ferrous Oxalate

  • Ferrous Sulphide

  • Formic Acid

  • Gall

  • Gelsemium sempervirens

  • Gneiss

  • Hamamelis virginiana

  • Hepar Sulfuris

  • Hyoscyamus niger

  • Iris florentine

  • Jaborandi

  • Juniperus sabina

  • Kaolinite

  • Lachmanthus tinctoria

  • Lapis Albus

  • Lycopodium

  • Magnesium

  • Magnesium Acetate

  • Magnesium Chloride

  • Magnetite

  • Manganese Acetate

  • Nicotiana tabacum

  • Nicotiana tabacum oil

  • Oleander

  • Opuntia vulgaris

  • Oxalic Acid

  • Petroleum

  • Phellandrium aquaticum

  • Pix Liquida

  • Platinum

  • Platinum Chloride

  • Potassium Hydroxide

  • Potassium Silicate

  • Pyrethrum

  • Pyrolusite

  • Ranunculus acris

  • Ranunculus bulbosus

  • Ranunculus flammula

  • Ranunculus repens

  • Ranunculus scelerantus

  • Rhodium Oxynitrate

  • Rhododendron chrysanthemum

  • Rhus toxicidendron

  • Salicylic Acid

  • Scrophularia aquatica

  • Sodium Aluminium Chloride

  • Sodium Auro-chloride

  • Sodium Hypochlorite

  • Sodium Nitrate

  • Squill

  • Stannum Metal

  • Sulphur Iodide

  • Tannic Acid

  • Terebinthinae Oleum

  • Topaz

  • Uric Acid

  • Zinc Hypophosphite

  • Zinc Isovalerate

Regulation 249

SCHEDULE 22U.K.Classes of person for the purposes of regulation 249

Doctors

Dentists

Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

Authorities or persons carrying on the business of—

(a)an independent hospital, independent clinic or independent medical agency,

(b)a hospital or health centre which is not an independent hospital or independent clinic, or

(c)in Northern Ireland, a nursing home.

Holders of wholesale dealer's licences or persons to whom the restrictions imposed by regulation 18(1) do not apply by virtue of an exemption in these Regulations.

Ministers of the Crown and Government departments.

Scottish Ministers.

Welsh Ministers.

A Northern Ireland Minister.

An NHS trust.

An NHS foundation trust.

[F193A local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006).]

Textual Amendments

[F194Public Health England.]

Textual Amendments

F194Words in Sch. 22 inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(2) and words in Sch. 22 inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(2)

[F194Public Health Agency.]

The Common Services Agency.

A health authority or a special health authority.

F195. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

A person other than an excepted person who carries on a business consisting (wholly or partly) of supplying medicinal products in circumstances corresponding to retail sale, or of administering such products, pursuant to an arrangement made with—

(a)an NHS trust or an NHS foundation trust;

(b)the Common Services Agency;

(ba)[F159an integrated care board];

[F196(bb)the National Health Service Commissioning Board;]

[F197(bc) a local authority;

(bd)Public Health England;

(be)Public Health Agency; or]

(c)a health authority or a special health authority; F198...

F198(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F197Words in Sch. 22 substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(3) and words in Sch. 22 substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(3)

A person other than an excepted person who carries on a business consisting (wholly or partly) of the supply or administration of medicinal products for the purpose of assisting the provision of health care by or on behalf of, or under arrangements made by—

(a)a police force in England, Wales or Scotland;

(b)the Police Service of Northern Ireland;

(c)a prison service; F199...

[F200(d) Her Majesty’s Forces; or

(e)a contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency.]

Textual Amendments

F199Word in Sch. 22 omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(4) and word in Sch. 22 omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(4)

F200Words in Sch. 22 substituted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 8(5) and words in Sch. 22 substituted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 8(5)

In this Schedule “excepted person” means—

(a)a doctor or dentist; or

(b)a person lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

Regulation 253

SCHEDULE 23U.K.Particulars in pharmacy records

1.  Paragraph 2 applies, subject to paragraph 3, where the sale or supply of a prescription only medicine is—U.K.

(a)in pursuance of a prescription given by—

(i)a doctor or dentist,

(ii)a supplementary prescriber,

(iii)a community practitioner nurse prescriber,

(iv)a nurse independent prescriber,

[F201(v)an optometrist independent prescriber,

(vi)a pharmacist independent prescriber,

(vii)a podiatrist independent prescriber,

(viii)a physiotherapist independent prescriber, F202...

(ix)a therapeutic radiographer independent prescriber; or]

[F203(x)a paramedic paramedic independent prescriber; or]

(b)under regulation 224 (emergency sale etc by pharmacist: prescriber unable to provide prescription).

Textual Amendments

F201Sch. 23 para. 1(a)(v)-(ix) substituted for Sch. 23 para. 1(a)(v)(vi) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 17 and Sch. 23 para. 1(a)(v)-(ix) substituted for Sch. 23 para. 1(a)(v)(vi) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 17

F202Word in Sch. 23 para. 1(a)(viii) omitted (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 13(2)(a) and word in Sch. 23 para. 1(a)(viii) omitted (N.I.) (1.4.2018) by virtue of The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 13(2)(a)

F203Sch. 23 para. 1(a)(x) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 13(2)(b) and Sch. 23 para. 1(a)(x) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 13(2)(b)

2.  In such a case, the particulars referred to in regulation 253(2)(a) are—U.K.

(a)the date on which the prescription only medicine was sold or supplied;

(b)the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;

(c)the name and address of the person giving the prescription;

(d)the name and address of the person for whom the prescription only medicine was prescribed;

(e)the date on the prescription; and

(f)in relation to the sale or supply of a prescription only medicine under regulation 224 the date on which the prescription relating to that sale or supply is received.

3.  Where the sale or supply is in pursuance of a repeatable prescription and is not the first sale or supply in pursuance of that prescription, the particulars referred to in regulation 253(2)(a) are either—U.K.

(a)the date on which the prescription only medicine is sold or supplied and a reference to the entry in the record referred to in regulation 253(1) which was made in respect of the first sale or supply in pursuance of that prescription and which contains the particulars specified in paragraph 2; or

(b)the particulars specified in paragraph 2.

4.  Where the sale or supply of a prescription only medicine is a sale or supply under regulation 225 (emergency sale etc by pharmacist: at patient's request), the particulars referred to in regulation 253(2)(a) are—U.K.

(a)the date on which the prescription only medicine was sold or supplied;

(b)the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;

(c)the name and address of the person requiring the prescription only medicine; and

(d)the nature of the emergency.

5.  Paragraph 6 applies where—U.K.

(a)the sale or supply of a prescription only medicine is by way of wholesale dealing and no order or invoice or copy of the order or invoice has been retained under regulation 224 or 225; or

(b)the sale or supply is one to which regulation 214(1) does not apply by reason of an exemption other than that in regulation 224 or 225.

6.  In such a case, the particulars referred to in regulation 253(2)(a) are—U.K.

(a)the date on which the prescription only medicine is sold or supplied;

(b)the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine sold or supplied;

(c)the name and address and trade, business or profession of the person to whom the prescription only medicine is sold or supplied; and

(d)the purpose for which the prescription only medicine is sold or supplied.

Regulation 257

SCHEDULE 24U.K.Packaging information requirements

PART 1U.K.Outer and immediate packaging

1.  The name of the medicinal product.U.K.

2.  The strength and pharmaceutical form of the product.U.K.

3.  Where appropriate, whether the product is intended for babies, children or adults.U.K.

4.  Where the product contains up to three active substances, the common name of each active substance.U.K.

5.  A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names.U.K.

6.  The pharmaceutical form and the contents by weight, by volume or by number of doses of the product.U.K.

7.  A list of—U.K.

(a)where the product is injectable or is a topical or eye preparation, all excipients; or

(b)in any other case, those excipients known to have a recognized action or effect and included in the guidance [F204published under regulation 257D in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products.].

Textual Amendments

8.  The method of administration of the product and if necessary the route of administration.U.K.

9.  Where appropriate, space for the prescribed dose to be indicated.U.K.

10.  A warning that the product must be stored out of the reach and sight of children.U.K.

11.  Any special warning applicable to the product.U.K.

12.  The product's expiry date (month and year), in clear terms.U.K.

13.  Any special storage precautions relating to the product.U.K.

14.  Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place.U.K.

15.  The name and address of the holder of the [F205UK marketing authorisation, EU marketing authorisation] Article 126a authorisation or traditional herbal registration relating to the product and, where applicable, the name of the holder's representative.U.K.

Textual Amendments

16.  The number of the [F206UK marketing authorisation, EU marketing authorisation] Article 126a authorisation or traditional herbal registration for placing the medicinal product on the market.U.K.

Textual Amendments

17.  The manufacturer's batch number.U.K.

18.  In the case of a product that is not a prescription only medicine, instructions for use.U.K.

[F20718A.  In the case of a medicinal product, other than a radiopharmaceutical, that is required by Article 54a of the 2001 Directive to bear safety features—U.K.

(a)a unique identifier which complies with the technical specifications set out in Chapter II of Commission Regulation 2016/161; and

(b)an anti-tampering device allowing verification of whether the packaging of the medicinal product has been tampered with.]

Textual Amendments

PART 2U.K.Immediate packaging: blister packs

19.  The name of the medicinal product.U.K.

20.  The strength and pharmaceutical form of the product.U.K.

21.  Where appropriate, whether the product is intended for babies, children or adults.U.K.

22.  Where the product contains up to three active substances, the common name of each active substance.U.K.

23.  The name of the holder of the [F208UK marketing authorisation, EU marketing authorisation], Article 126a authorisation or traditional herbal registration relating to the product.U.K.

Textual Amendments

24.  The product's expiry date (month and year), in clear terms.U.K.

25.  The manufacturer's batch number.U.K.

PART 3U.K.Immediate packaging: small packages

26.  The name of the medicinal product.U.K.

27.  The strength and pharmaceutical form of the product.U.K.

28.  Where appropriate, whether the product is intended for babies, children or adults.U.K.

29.  Where the product contains up to three active substances, the common name of each active substance.U.K.

30.  The method of administration of the product and if necessary the route of administration.U.K.

31.  The product's expiry date (month and year), in clear terms.U.K.

32.  The manufacturer's batch number.U.K.

33.  The contents of the packaging by weight, by volume or by unit.U.K.

[F209PART 4U.K.Outer and immediate packaging: advanced therapy medicinal products for sale or supply in Great Britain only

Textual Amendments

34.  The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name.

35.  Where appropriate, whether the product is intended for babies, children or adults.

36.  The expiry date in clear terms including the year and month and, if applicable, day.

37.  A description of the active substance, expressed qualitatively and quantitatively.

38.  Where the product contains tissues and cells of human or animal origin—

(a)a statement that the product contains such cells or tissues; and

(b)a short description of the cells or tissues and of their specific origin, including the species of animal in cases on non-human origin.

39.  The pharmaceutical form and the contents by weight, volume or number of doses of the product.

40.  A list of excipients, including preservative systems.

41.  The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated.

42.  A special warning that the product is to be stored out of the sight and reach and children.

43.  Any special warning necessary for the particular product.

44.  Any special storage precautions.

45.  Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system.

46.  The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him.

47.  The UK marketing authorisation number.

48.  The manufacturer's batch number.

49.  The unique donation code assigned by a tissue establishment pursuant to—

(a)paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b)paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.

50.  Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

PART 5U.K.Immediate packaging: blister packs and small packaging (advanced therapy medicinal products for sale or supply in Great Britain only)

51.  The information specified in Part 2.

52.  The unique donation code assigned by a tissue establishment pursuant to—

(a)paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b)paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.

53.  Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.]

Regulation 258

SCHEDULE 25U.K.Packaging requirements: specific provisions

PART 1U.K.Medicines on prescription

1.  Where the product is to be administered to a particular individual, the name of that individual.U.K.

2.  The name and address of the person who sells or supplies the product.U.K.

3.  The date on which the product is sold or supplied.U.K.

4.  Unless paragraph 5, applies, such of the following particulars as the appropriate practitioner who prescribed the product may specify—U.K.

(a)the name of the product or its common name;

(b)directions for use of the product; and

(c)precautions relating to the use of the product.

5.  This paragraph applies if the pharmacist, in the exercise of professional skill and judgement, is of the opinion that the inclusion of one or more of the particulars mentioned in paragraph 4 is inappropriate.U.K.

6.  Where paragraph 5 applies, the pharmacist may include such particulars, of the same kind as those mentioned in paragraph 4, as the pharmacist thinks appropriate.U.K.

PART 2U.K.Transport, delivery and storage

7.  Any special requirements for the storage and handling of the product.U.K.

8.  The expiry date of the product.U.K.

9.  The manufacturer's batch number.U.K.

PART 3U.K.Pharmacy and prescription only medicines

10.  Paragraph 11 applies if a pharmacy medicine is—U.K.

(a)sold by retail;

(b)supplied in circumstances corresponding to retail sale;

(c)in the possession of a person for the purpose of sale or supply as mentioned in paragraph (a) or (b), or

(d)distributed by way of wholesale dealing.

11.  Where this paragraph applies, the capital letter “P” within a rectangle within which there is to be no other matter of any kind.U.K.

12.  Paragraph 13 applies if a prescription only medicine is—U.K.

(a)sold by retail;

(b)supplied in circumstances corresponding to retail sale;

(c)in the possession of a person for the purpose of sale or supply as mentioned in paragraph (a) or (b); or

(d)distributed by way of wholesale dealing.

13.  Where this paragraph applies, the capital letters “POM” within a rectangle within which there is to be no other matter of any kind.U.K.

PART 4U.K.Medicines containing paracetamol

14.  If the product contains paracetamol, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “Contains paracetamol”.U.K.

15.  If the product contains paracetamol the words “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”, which must appear adjacent to either the directions for use or the recommended dosage.U.K.

16.  If the product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or younger, the words “Do not take anything else containing paracetamol while taking this medicine” and—U.K.

(a)if a package leaflet accompanying the product includes the words in quotation marks in paragraph 16 of Schedule 27 (package leaflets), the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well”; or

(b)if no package leaflet accompanies the product or the package leaflet does not include those words, the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage”.

17.  If the product contains paracetamol and is wholly or mainly intended for children twelve years old or younger, the words “Do not give anything else containing paracetamol while giving this medicine” and—U.K.

(a)if a package leaflet accompanying the product includes the words in quotation marks in paragraph 17 of Schedule 27 (package leaflets), the words “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well”; or

(b)if no package leaflet accompanies the product or the package leaflet does not include those words, the words “Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage”.

18.  If the product is required by this Part of this Schedule to show the words set out in paragraphs 14, 16 or 17, those words must appear in a prominent position.U.K.

Regulations 3(13) and 4(5)

SCHEDULE 26U.K.Packaging requirements: special provisions

PART 1U.K.Supply by doctors, dentists, nurses and midwives

1.  Where the product is to be administered to a particular individual, the name of that individual.U.K.

2.  The name and address of the person who sells or supplies the product.U.K.

3.  The date on which the product is sold or supplied.U.K.

4.  Such of the following particulars as the person under whose responsibility the product is sold or supplied considers appropriate—U.K.

(a)the name of the product or its common name;

(b)directions for use of the product; and

(c)precautions relating to the use of the product.

PART 2U.K.Pharmacy exceptions

5.  Where the product is to be administered to a particular individual, the name of that individual.U.K.

6.  The name and address of the person who sells or supplies the product.U.K.

7.  The date on which the product is sold or supplied.U.K.

8.  Where the product is prescribed by an appropriate practitioner, such of the following particulars as the appropriate practitioner who prescribed the product may specify, unless paragraph 9 applies —U.K.

(a)the name of the product or its common name;

(b)directions for use of the product; and

(c)precautions relating to the use of the product.

9.  This paragraph applies if a pharmacist, in the exercise of professional skill and judgement, is of the opinion that the inclusion of one or more of the particulars specified in paragraph 8 by the appropriate practitioner who prescribed the product is inappropriate.U.K.

10.  Where paragraph 9 applies, the pharmacist may include such particulars, of the same kind as those mentioned in paragraph 8, as the pharmacist thinks appropriate.U.K.

11.  Where the product is not prescribed by an appropriate practitioner, directions for use of the product, but these may be omitted in circumstances where section 10(3) of the Medicines Act 1968 applies.U.K.

Regulation 260

SCHEDULE 27U.K.Package leaflets

PART 1U.K.General requirements

1.  The name of the medicinal product.U.K.

2.  The strength and pharmaceutical form of the product.U.K.

3.  Where appropriate, whether the product is intended for babies, children or adults.U.K.

4.  Where the product contains up to three active substances, the common name of each active substance.U.K.

5.  The pharmaco-therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.U.K.

6.  The product's therapeutic indications.U.K.

7.  A list of—U.K.

(a)contra-indications;

(b)appropriate precautions for use;

(c)interactions with other medicinal products which may affect the action of the product;

(d)interactions with other substances, including alcohol, tobacco and foodstuffs, which may affect the action of the product; and

(e)special warnings, if any, relating to the product.

8.  The list mentioned in paragraph 7 must—U.K.

(a)take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);

(b)mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; and

(c)list any excipients—

(i)if knowledge of the excipients is important for the safe and effective use of the product, and

(ii)the excipients are included in the guidance published pursuant to [F210published under regulation 257D in the case of products for sale or supply in Great Britain, or in the case of products for sale or supply in Northern Ireland, any guidance published pursuant to Article 65 of the 2001 Directive or under regulation 257D that is applicable to such products.]

Textual Amendments

9.  Instructions for proper use of the product including in particular—U.K.

(a)the dosage;

(b)the method and, if necessary, route of administration;

(c)the frequency of administration (including, if necessary, specifying times at which the product may or must be administered);

(d)the duration of treatment if this is to be limited;

(e)symptoms of an overdose and the action, if any, to be taken in case of an overdose;

(f)what to do if one or more doses have not been taken;

(g)an indication, if necessary, of the risk of withdrawal effects; and

(h)a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product.

10.  A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.U.K.

11.  A reference to the expiry date printed on the packaging of the product with—U.K.

(a)a warning against using the product after that date;

(b)if appropriate, details of special storage precautions to be taken;

(c)if necessary, a warning concerning visible signs of deterioration;

(d)the full qualitative composition (in active substances and excipients), and the quantitative composition in active substances, using common names, of each presentation of the medicinal product;

(e)for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage;

(f)the name and address of the holder of the [F211UK marketing authorisation, EU marketing authorisation], Article 126a authorisation or traditional herbal registration relating to the product and, if applicable, the name of the holder's appointed representative; and

(g)the name and address of the manufacturer of the product.

Textual Amendments

12.  Where the product [F212is authorised for sale or supply in Northern Ireland and] is authorised under different names in different member States in accordance with Articles 28 to 39 of the 2001 Directive, a list of the names authorised in each member State.U.K.

Textual Amendments

13.  For medicinal products included in the list referred to in Article 23 of Regulation (EC) No 726/2004 [F213in the case of products for sale or supply in Northern Ireland, or the list referred to in regulation 202A, in the case of products for sale or supply in Great Britain,] the [F214symbol and ] statement: “[F215▼] This medicinal product is subject to additional F216... monitoring”.U.K.

Textual Amendments

[F21714.  A standardised text relating to adverse event reporting in accordance with the third sub-paragraph of Article 59(1) of the 2001 Directive.]U.K.

Textual Amendments

15.  The date on which the package leaflet was last revised.U.K.

PART 2U.K.Paracetamol

16.  If a medicinal product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or younger, the words “Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage”.U.K.

17.  If a medicinal product contains paracetamol and is wholly or mainly intended for children twelve years old or younger, the words “Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage”.U.K.

[F218Part 3U.K.Advanced therapy medicinal products for sale or supply in Great Britain only

Textual Amendments

18.  The name of the advanced therapy medicinal product.

19.  Where appropriate, whether the product is intended for babies, children or adults.

20.  The common name of the advanced therapy medicinal product.

21.  The therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.

22.  Where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.

23.  Where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin.

24.  The product's therapeutic indications.

25.  A list of information which is necessary before the medicinal product is taken or used, including—

(a)contra-indications;

(b)appropriate precautions for use;

(c)interactions with other medicinal products which may affect the action of the product;

(d)interactions with other substances, including alcohol, tobacco and foodstuffs which may affect the action of the product;

(e)special warnings; if any, relating to the product.

26.  The list mentioned in paragraph 25 must—

(a)take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);

(b)mention, if appropriate, possible effects on the ability to drive vehicles or operate machinery; and

(c)list any excipients—

(i)if knowledge of the excipients is important for the safe and effective use of the product; and

(ii)the excipients are included in the guidance published under regulation 257D.

27.  Instructions for proper use of the product including in particular—

(a)the dosage;

(b)the method of use, application, administration or implantation and, if necessary, the route of administration;

(c)the frequency of administration (including, if necessary, specifying the times at which the product may or must be administered);

(d)the duration of treatment if this is to be time limited;

(e)symptoms of an overdose and the action, if any, to be taken in the case of an overdose;

(f)what to do if one or more doses have not been taken;

(g)a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product.

28.  A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.

29.  A reference to the expiry date printed on the packaging of the product with—

(a)a warning against using the product after that date;

(b)if appropriate, details of special storage precautions to be taken;

(c)if necessary, a warning concerning visible signs of deterioration;

(d)the full qualitative and quantitative composition;

(e)the name and address of the UK marketing authorisation holder and, if applicable, the name of the holder's appointed representative; and

(f)the name and address of the manufacturer.

30.  The date on which the package leaflet was last revised.]

Regulation 264

SCHEDULE 28U.K.Labelling requirements for registrable homoeopathic medicinal products

PART 1U.K.Outer and immediate packaging

1.  The scientific name of the stock or stocks (which may be supplemented by an invented name if the product contains two or more stocks), and the degree of dilution, making use of the symbols of the European Pharmacopoeia or, in the absence of an entry in the European Pharmacopoeia, of the British Pharmacopoeia.U.K.

2.  The name and address of the holder of the certificate of registration and, if different, the manufacturer.U.K.

3.  The method and, if necessary, route of administration.U.K.

4.  The product's expiry date (month and year), in clear terms.U.K.

5.  The product's pharmaceutical form.U.K.

6.  The contents of the presentation, specified by weight, volume or number of doses.U.K.

7.  Special storage precautions, if any.U.K.

8.  A special warning, if necessary in relation to the product.U.K.

9.  The manufacturer's batch number.U.K.

10.  The number of the certificate of registration.U.K.

11.  The words “homoeopathic medicinal product without therapeutic indications”.U.K.

12.  A warning advising the user to consult a doctor if symptoms persist.U.K.

PART 2U.K.Blister packs etc contained in outer packaging

13.  The scientific name of the stock or stocks (which may be supplemented by an invented name if the product contains two or more stocks), and the degree of dilution, making use of the symbols of the European Pharmacopoeia or, in the absence of an entry in the European Pharmacopoeia, of the British Pharmacopoeia.U.K.

14.  The name and address of the holder of the certificate of registration.U.K.

15.  The product's expiry date (month and year), in clear terms.U.K.

16.  The manufacturer's batch number.U.K.

17.  The words “homoeopathic medicinal product without therapeutic indications”.U.K.

PART 3U.K.Small immediate packaging

18.  The scientific name of the stock or stocks (which may be supplemented by an invented name if the product contains two or more stocks), and the degree of dilution, making use of the symbols of the European Pharmacopoeia or, in the absence of an entry in the European Pharmacopoeia, of the British Pharmacopoeia.U.K.

19.  The name and address of the holder of the certificate of registration.U.K.

20.  The method and, if necessary, route of administration.U.K.

21.  The product's expiry date (month and year), in clear terms.U.K.

22.  The contents of the presentation, specified by weight, volume or number of doses.U.K.

23.  The manufacturer's batch number.U.K.

24.  The words “homoeopathic medicinal product without therapeutic indications”.U.K.

Regulation 265

SCHEDULE 29U.K.Labelling of traditional herbal medicinal products

PART 1U.K.Traditional herbal medicinal products: general

1.  A statement to the effect that the product is a traditional herbal medicinal product, for use for specific purposes by reason of long-standing use.U.K.

2.  A statement that the user should consult a doctor or other health care practitioner if symptoms persist during use of the medicinal product, or if adverse effects not mentioned on the package or package leaflet occur.U.K.

PART 2U.K.Traditional herbal medicinal products not subject to general sale

3.  Subject to the provisions of regulation 265(2), paragraph 4 applies where a traditional herbal medicinal product that is a pharmacy medicine is—U.K.

(a)sold by retail;

(b)supplied in circumstances corresponding to retail sale;

(c)in the possession of a person for the purpose of sale or supply as mentioned in paragraph (a) or (b); or

(d)distributed by way of wholesale dealing.

4.  Where this paragraph applies, the outer packaging and the immediate packaging of the product must be labelled to show the capital letter “P” within a rectangle, within which there is to be no other matter of any kind.U.K.

Regulations 294, 295 and 297

SCHEDULE 30U.K.Particulars for advertisements to persons qualified to prescribe or supply

1.  The number of the [F219UK marketing authorisation, EU marketing authorisation], certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product.U.K.

Textual Amendments

2.  The name and address of the holder of [F220the temporary authorisation or] the [F221UK marketing authorisation, EU marketing authorisation], certificate of registration, traditional herbal registration or Article 126a authorisation for the medicinal product or the business name and address of the part of the holder's business that is responsible for its sale or supply.U.K.

Textual Amendments

[F2222A.  In relation to an advertisement in Great Britain (other than an advertisement falling within the exception in regulation 296) where the medicinal product concerned is authorised under a UKMA(GB), a statement that the product concerned is authorised under a UKMA(GB).]U.K.

Textual Amendments

3.  The classification of the medicinal product as—U.K.

(a)a product that is subject to general sale;

(b)a prescription only medicine; or

(c)a pharmacy medicine.

4.  The name of the medicinal product.U.K.

5.  A list of the active ingredients of the medicinal product that uses their common names and is placed immediately adjacent to the most prominent display of the name of the product.U.K.

6.  One or more of the indications for the medicinal product consistent with the terms of the [F223UK marketing authorisation, EU marketing authorisation], certificate of registration, traditional herbal registration or Article 126a authorisation for the product [F224or, in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174, the indications for the medicinal product consistent with the recommendation or requirement of the licensing authority as to the use of that product].U.K.

Textual Amendments

7.  [F225The entries or a] succinct statement of the entries (if any) in the summary of the product characteristics[F226, or in any equivalent summary published by the holder of a temporary authorisation,] relating to—

(a)adverse reactions, precautions and relevant contra-indications;

(b)dosage and method of use so far as relevant to the indications shown in the advertisement, and

(c)where this is not obvious, method of administration so far as relevant to those indications.

Textual Amendments

F225Words in Sch. 30 para. 7 substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 29 and words in Sch. 30 para. 7 substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 29

8.  The cost excluding value added tax of—U.K.

(a)a specified package of the medicinal product; or

(b)a specified quantity or recommended daily dose of the medicinal product calculated by reference to a specified package of the medicinal product.

This paragraph does not apply to an advertisement inserted in a publication that is printed in the United Kingdom but that has a circulation outside the United Kingdom of more than 15 per cent of its total circulation.

9.—(1) The particulars specified in paragraph 7 must be printed in a clear and legible manner.U.K.

(2) Those particulars must be placed in such a position in the advertisement that their relationship to the claims and indications for the product can readily be appreciated by the reader.

Regulation 328(3)

SCHEDULE 31U.K.Sampling

Modifications etc. (not altering text)

C1Sch. 31 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

IntroductoryU.K.

1.—(1) This Schedule has effect where a person authorised by an enforcement authority (in this Schedule referred to as a “sampling officer”) obtains a sample of a substance or article—U.K.

(a)in order to determine whether there has been a contravention of any provision of these Regulations which the enforcement authority (“the relevant enforcement authority”) must or may enforce by virtue of regulations 323 and 324; or

(b)otherwise for a purpose connected with the performance of the relevant enforcement authority of its functions under these Regulations.

(2) This Schedule has effect whether the sample is obtained by purchase or in exercise of a power conferred by regulation 327.

(3) In this Schedule “medicines control laboratory” means a laboratory that is—

(a)designated by the licensing authority in accordance with Article 111(1) of the 2001 Directive for the purpose of the analysis of samples of one or more types of medicinal product; and

(b)is so designated in relation to a particular medicinal product that is submitted to it for analysis.

Division of sampleU.K.

2.  The sampling officer must as soon as practicable—U.K.

(a)divide the sample into three parts;

(b)mark each part;

(c)seal or fasten each part; and

(d)deal with the parts in accordance with paragraphs 3 to 10.

3.  If the sample was purchased by the sampling officer otherwise than from a vending machine the officer must supply one part of the sample to the seller.U.K.

4.  If the sampling officer obtained the sample from a vending machine—U.K.

(a)if a person's name and an address in the United Kingdom are stated on the machine as being the name and address of the owner of the machine, the sampling officer must supply one part of the sample to that person; and

(b)in any other case, the sampling officer must supply one part of the sample to the occupier of the premises on which the machine stands or to which it is affixed.

5.  If the sample is a sample of goods consigned from outside the United Kingdom, and was taken by the sampling officer before delivery to the consignee, the sampling officer must supply one part of the sample to the consignee.U.K.

6.  If, in a case not falling within any of paragraphs 3 to 5 of this Schedule, the sample was obtained by the sampling officer at the request or with the consent of a purchaser, the sampling officer must supply one part of the sample to the seller.U.K.

7.  If, in a case not falling within any of paragraphs 3 to 6 of this Schedule, the sample was taken in transit, the sampling officer must supply one part of the sample to the consignor.U.K.

8.  In any case not falling within any of paragraphs 3 to 7 of this Schedule, the sampling officer must supply one part of the sample to the person appearing to the sampling officer to be the owner of the substance or article from which the sample was taken.U.K.

9.  In every case falling within any of paragraphs 3 to 8 of this Schedule, the sampling officer must inform the person to whom the part of the sample in question is supplied that the sample has been obtained for the purpose of analysis or other examination.U.K.

10.  Unless the sampling officer decides not to submit the sample for analysis or other examination the sampling officer must—U.K.

(a)retain one of the two remaining parts for future comparison; and

(b)submit the other part for analysis or examination in accordance with the following provisions of this Schedule.

11.  If a sample consists of substances or articles in unopened containers, the sampling officer may divide the sample into parts by dividing the containers into three lots without opening them if it appears to the sampling officer that—U.K.

(a)it is not reasonably practicable to open the containers and divide the contents into parts; or

(b)opening the containers and dividing the contents into parts might affect the composition or impede the analysis or other examination of the contents.

12.  Regulation 343(1)(a) to (d) has effect in relation to supplying a part of a sample in pursuance of the preceding paragraphs as it has effect in relation to the service of a document.U.K.

13.  If after reasonable inquiry the sampling officer is unable to ascertain the name of a person to whom, or the address at which, a part of a sample should be supplied, the sampling officer may retain that part of the sample.U.K.

Notice to person named on containerU.K.

14.—(1) This paragraph applies where the sampling officer has obtained a sample of a substance or article and it appears to the sampling officer that—U.K.

(a)the substance or article was manufactured in the United Kingdom by a person (“M”) whose name and address in the United Kingdom are stated on its container or packaging; and

(b)M is not a person to whom a part of the sample must be supplied under the preceding provisions of this Schedule.

(2) Unless the sampling officer decides not to submit the sample for analysis or other examination, the sampling officer must give notice to M—

(a)stating that the sample has been obtained; and

(b)specifying the person from whom the sampling officer purchased it or, if it was obtained otherwise than by purchase, the place from which the sampling officer obtained it.

(3) Notice under sub-paragraph (2) must be given to M within the period of three days beginning immediately after the day on which the sample was obtained.

Analysis or other examinationU.K.

15.  Where the enforcing authority that authorises the sampling officer is the Secretary of State or the Minister for Health, Social Services and Public Safety, if the sampling officer decides to submit the sample for analysis the officer must do so—U.K.

(a)to a medicines control laboratory; or

(b)to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

16.  Where any other enforcing authority authorises the sampling officer, if the sampling officer decides to submit the sample for analysis the officer must do so to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.U.K.

17.—(1) Arrangements of the kind mentioned in paragraphs 15(b) and 16 made by an enforcement authority in England, Wales or Scotland other than the Secretary of State must be approved by the Secretary of State.U.K.

(2) Arrangements of the kind mentioned in paragraph 15(b) made by a district council in Northern Ireland must be approved by the Minister for Health, Social Services and Public Safety.

18.  A laboratory to which a sample is submitted under paragraph 15 or 16 must analyse or examine the sample as soon as practicable,U.K.

19.  A laboratory that has analysed or examined a sample submitted under the preceding provisions of this Schedule must issue and send to the sampling officer a certificate specifying the result of the analysis or examination.U.K.

20.  A person to whom a part of the sample is to be supplied in accordance with paragraphs 2 to 8 is entitled, on payment of the required fee, to be given a copy of any certificate as to the result of an analysis or examination which is sent to the sampling officer under paragraph 19.U.K.

Provisions as to evidenceU.K.

21.—(1) In proceedings for an offence under these Regulations, a document produced by one of the parties to the proceedings and purporting to be a certificate issued under paragraph 19 is to be sufficient evidence of the facts stated in the document unless sub-paragraph (2) applies.U.K.

(2) A party to proceedings, other than the party who produced the document mentioned in paragraph (1), may require that the person who issued the certificate be called as a witness.

(3) In proceedings in Scotland, if the person who issued the certificate is called as a witness, that person's evidence is to be sufficient evidence of the facts stated in the certificate.

22.  In proceedings for an offence under these Regulations, a document produced by one of the parties to the proceedings which has been supplied by another party to the proceedings as a copy of a certificate issued under paragraph 19 is to be sufficient evidence of the facts stated in the document.U.K.

23.—(1) If, in proceedings before a magistrates' court for an offence under these Regulations, a defendant intends to produce a certificate issued under paragraph 19, or to require that the person by whom a certificate was issued be called as a witness, the defendant must give notice of that intention and (where a certificate is to be produced) a copy of the certificate to the other party at least three clear days before the day on which the summons is returnable.U.K.

(2) If sub-paragraph (1) is not complied with the court may adjourn the hearing on such terms as it thinks fit.

(3) In Scotland, if in proceedings in the sheriff court for an offence under these Regulations the accused intends to produce a certificate under paragraph 19, or to require that the person by whom a certificate was issued be called as a witness, the accused must give notice of that intention and (where a certificate is to be produced) a copy of the certificate to the procurator fiscal at least three clear days before the day on which the case proceeds to trial.

(4) If sub-paragraph (3) is not complied with the sheriff may adjourn the diet on such terms as the sheriff thinks fit.

Analysis under direction of courtU.K.

24.—(1) This paragraph applies where proceedings for an offence under these Regulations relate to a substance or article of which a sample has been taken as mentioned in paragraph 1 of this Schedule.U.K.

(2) Where this paragraph applies, the part of the sample retained in pursuance of paragraph 10(a) is to be produced as evidence.

(3) The court must, if requested by a party to the proceedings, and may, in the absence of such a request, cause that part of the sample to be sent for analysis to the Government Chemist (or, in Northern Ireland, to the Government Chemist in Northern Ireland) or to be sent for other examination to a laboratory specified by the court.

(4) If, in a case where an appeal is brought, no action has been taken under sub-paragraph (3), that sub-paragraph applies to the court by which the appeal is heard.

(5) A person or laboratory to whom or to which a part of a sample is sent under this paragraph for analysis or other examination must—

(a)analyse or examine it; and

(b)issue and give to the court a certificate specifying the results of the analysis or examination.

(6) A certificate under sub-paragraph (5)(b) is to be evidence (and, in Scotland, is to be sufficient evidence) of the facts stated in the certificate unless a party to the proceedings requires that the person by whom it was issued be called as a witness.

(7) In Scotland, if the person by whom a certificate is issued is called as a witness that person's evidence is sufficient evidence of the facts stated in the certificate.

25.  The costs of analysis or examination under paragraph 24 are to be paid by the prosecutor or the defendant (or, in Scotland, the accused) as the court may order.U.K.

Proof by written statementU.K.

26.—(1) In relation to England and Wales section 9 of the Criminal Justice Act 1967 M22 does not have effect with respect to a document produced as mentioned in paragraph 21 or 22, or with respect to any certificate transmitted to a court under paragraph 24.U.K.

(2) In relation to Northern Ireland any enactment corresponding to section 9 of the Criminal Justice Act 1967 does not have effect with respect to a document produced as mentioned in paragraph 21 or 22, or with respect to any certificate transmitted to a court under paragraph 24.

Marginal Citations

Payment for sample taken under compulsory powersU.K.

27.—(1) Where a sampling officer takes a sample in the exercise of a power conferred by regulation 327, the officer must, if payment is required, pay the value of the sample to the person to whom a part of the sample is required to be supplied under paragraph 5, 7 or 8 (as the case may be) of this Schedule.U.K.

(2) If the sampling officer and the person mentioned in sub-paragraph (1) are unable to agree, the value of the sample is to be determined—

(a)by the arbitration of a single arbitrator appointed by the sampling officer and the other person in question; or

(b)if they are unable to agree on an arbitrator, by the county court for the district (or in Northern Ireland the division) in which the sample was taken.

(3) In the application of this paragraph to Scotland for references to the county court there is to be substituted a reference to the sheriff.

Regulation 347

SCHEDULE 32U.K.Transitional provisions and savings

Continuity of the lawU.K.

1.—(1) This paragraph applies where any provision of these Regulations re-enacts (with or without modification) an enactment or instrument repealed or revoked by these Regulations.U.K.

(2) The repeal and re-enactment do not affect the continuity of the law.

(3) Anything done, or having effect as if done, under or for the purposes of the repealed provision that could have been done under or for the purposes of the corresponding provision of these Regulations, if in force or effective immediately before the commencement of that corresponding provision, has effect thereafter as if done under or for the purposes of that corresponding provision.

(4) Any reference (express or implied) in these Regulations or any other enactment, instrument or document to a provision of these Regulations is to be construed (so far as the context permits) as including, as respects times, circumstances or purposes in relation to which the corresponding repealed provision had effect, a reference to that corresponding provision.

(5) Any reference (express or implied) in any enactment, instrument or document to a repealed provision is to be construed (so far as the context permits), as respects times, circumstances and purposes in relation to which the corresponding provision of these Regulations has effect, as being or (according to the context) including a reference to the corresponding provision of these Regulations.

(6) This paragraph has effect subject to any specific transitional provision or saving in this Schedule.

Product licencesU.K.

2.—(1) This paragraph applies to a marketing authorisation that—U.K.

(a)became a marketing authorisation on 1st January 1995 by virtue of paragraph 1 of Schedule 6 M23 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (conversion of existing product licences); and

(b)by virtue of paragraph 1 of this Schedule, has effect from the coming into force of these Regulations as a marketing authorisation granted under these Regulations.

(2) The following provisions do not apply in relation to the marketing authorisation—

(a)regulation 68(7) (revocation etc of marketing authorisation because the holder has ceased to be established in the EU); and

(b)regulation 258 (packaging requirements: specific provisions).

(3) Paragraph (4) applies if the marketing authorisation has not been renewed in the period beginning with 1st January 1995 and ending when these Regulations come into force.

(4) The Medicines (Labelling) Regulations 1976 M24 and the Medicines (Leaflets) Regulations 1977 M25 (and subsequent regulations amending those regulations) in so far as they relate to medicinal products continue to have effect in relation to the product to which the marketing authorisation relates until the marketing authorisation is renewed.

Marginal Citations

M23S.I. 1994/3144, as amended by S.I. 2004/3224 and S.I. 2005/2759. There are other amendments to those regulations that are not relevant to this paragraph..

Product licences of rightU.K.

3.—(1) This paragraph applies to a product licence of right.U.K.

(2) In this paragraph, “product licence of right” means a licence of right within the meaning of section 25(4) of the Medicines Act 1968 that—

(a)has been issued in relation to the requirements to hold a product licence contained in section 7(2) of that Act; and

(b)is in force immediately before the coming into force of these Regulations.

(3) A product licence of right shall continue in force, subject to the following sub-paragraphs.

(4) Parts 4 to 11, 13 and 14 of these Regulations shall not apply in relation to a medicinal product that is the subject of a product licence of right, except as provided in the following sub-paragraphs.

(5) A medicinal product to which a product licence of right relates shall—

(a)continue to be classified as a prescription only medicine, a medicinal product not subject to general sale, or a medicinal product subject to general sale, as the case may be, in accordance with the provisions of the Medicines Act 1968 and any statutory instrument made under that Act that was in force immediately before the coming into force of these regulations; and

(b)shall be treated as a prescription only medicine, a pharmacy medicine not subject to general sale, or a medicine subject to general sale respectively, as the case may be, for the purposes of Part 12 of these Regulations.

(6) The provisions listed in sub-paragraph (7), and any provisions to which they refer, shall continue to have effect as they did immediately before the coming into force of these Regulations in relation to a product licence of right and to the product to which it relates.

(7) Those provisions are—

(a)section 28(1), (2) and (3)(a) to (e) and (g) to (j) (general power to suspend, revoke or vary licences) of the Medicines Act 1968 M26;

(b)the Medicines (Advertising of Medicinal Products) (No. 2) Regulations 1975 M27;

(c)the Medicines (Labelling) Regulations 1976 M28;

(d)the Medicines (Leaflets) Regulations 1977 M29; and

(e)the Medicines (Labelling and Advertising to the Public) Regulations 1978 M30.

(8) Part 1 of Schedule 11 (advice and representations) shall have effect where the licensing authority proposes to exercise any power conferred by section 28 of the Medicines Act referred to in sub-paragraph 7(a) in relation to a product licence of right, as if that proposal concerned the suspension, revocation or variation of a UK marketing authorisation, certificate of registration or traditional herbal registration under these Regulations.

(9) Without prejudice to any requirement of Part 1 of Schedule 11 as to the service of notices, where in the exercise of any such power the licensing authority suspends, revokes or varies a product licence of right, it must serve a notice on the holder a notice giving particulars of the suspension, revocation or variation and of the reasons for its decision to suspend, vary or revoke the product licence of right.

(10) Regulations [F227268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)] and 271 (offences: penalties) shall have effect in relation to the provisions in sub-paragraph (7)(d) as if—

(a)references to the holder of a marketing authorisation included reference to the holder of a product licence of right; and

(b)the provisions in sub-paragraph (7)(d) were requirements of Part 13.

(11) A product licence of right shall cease to be in force at the same time that a marketing authorisation, certificate of registration or traditional herbal registration is granted in respect of the product to which the product licence of right relates.

Textual Amendments

Marginal Citations

M26Section 28(3) was amended by Schedule 1 to the Animal Health and Welfare Act 1984 (1984 c.40), regulation 4(5) of S.I. 1977/1050, regulation 2(2) of S.I. 1975/1169, regulation 6(2) of S.I. 1994/276, regulation 2(a)(iii) of S.I. 2002/236 and paragraph 14 of Schedule 8 to S.I. 2006/2407.

Classification of UK marketing authorisation and certificate of registrationU.K.

4.—(1) Sub-paragraph (3) applies to a UK marketing authorisation granted before 1st April 2002 if—U.K.

(a)the authorisation contains a statement that the product to which the authorisation relates is to be available on one or more of the bases set out in paragraph (2); or

(b)the product to which the authorisation relates is to be available on one or more of the bases set out in paragraph (2) by virtue of any enactment in force immediately before the coming into force of these Regulations.

(2) Those bases are that the product is to be available—

(a)only on prescription;

(b)only from a pharmacy; or

(c)on general sale.

(3) It is a condition of the UK marketing authorisation that the product is only to be available on that basis or those bases.

Advanced therapy medicinal productsU.K.

5.  No provision of these Regulations that applies only to advanced therapy medicinal products shall apply until 30th December 2012 to advanced therapy medicinal products which—U.K.

(a)are tissue engineered products; and

(b)were legally on the market in the United Kingdom in accordance with United Kingdom or European Union legislation on 30th December 2008.

Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)U.K.

6.  Regulation 9 (amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004) of the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 M31 remains in force.U.K.

Marginal Citations

Section 60 of the Medicines Act 1968 etcU.K.

7.—(1) Section 60 of the Medicines Act 1968 (“the Act”) shall continue to have effect insofar as it relates to the making of, and continued operation of, the Medicines (Administration of Radioactive Substances) Regulations 1978 M32 (“the 1978 Regulations”).U.K.

(2) The following provisions of the Act shall continue to have effect as they did immediately before the coming into force of these Regulations in relation to the following provisions of the 1978 Regulations—

(a)section 22A(2) to (9) and 10(b) (hearing before person appointed) of the Act, in relation to regulation 7 (hearings and written representations) of the 1978 Regulations;

(b)section 67(2) and (4) (offences under Part III) of the Act, as they relate to section 60 of the Act, in relation to regulation 8 (application of provisions of the Act) of the 1978 Regulations; and

(c)paragraphs 7, 8, 9(3) and 10 to 12 of Schedule 1A (provisions relating to Commission and committees) to the Act M33, in relation to the committee established under regulation 3 (advisory committee) of the 1978 Regulations.

Marginal Citations

M331968 c.67. Schedule 1A was inserted by regulation 7(2) of S.I. 2005/1094.

Regulation 212

SCHEDULE 33U.K.Transitional arrangements: pharmacovigilance

Pharmacovigilance system master fileU.K.

F2281.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2292.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

Post-authorisation safety studiesU.K.

3.  Regulations 198, 199, 200, 201 and 202 (provisions relating to post authorisation safety studies) do not apply to post authorisation safety studies commenced before 21st July 2012.

4.  Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004) does not apply to post authorisation safety studies commenced before 21stJuly 2012.U.K.

Reporting obligationsU.K.

F2305.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2306.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F2307.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F2308.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

Periodic safety update reportsU.K.

F2309.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F23010.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

Regulation 347A

[F231SCHEDULE 33AU.K.Transitional provision in relation to EU Exit

Textual Amendments

PART 1U.K.Interpretation

1.  In this Schedule—U.K.

“the COMP” means the Committee for Orphan Medicinal Products of the EMA, established under Article 4 of the Orphan Regulation;

“converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2);

“the Paediatric Regulation” means Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, as it has effect in EU law;

“the Paediatric Committee” means the committee of the EMA established under Article 3 of the Paediatric Regulation;

“the Pharmacovigilance Risk Assessment Committee” means the Committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004; and

“Regulation (EC) No 507/2006” means Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council, as it has effect in EU law.

PART 2U.K.Manufacturing, wholesale dealing and brokering

Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion dayU.K.

2.—(1) Subject to sub-paragraphs (2) and (3), a person (“P”) who is the holder of a wholesale dealer's licence which—

(a)was granted before IP completion day by the licensing authority;

(b)was in force immediately before IP completion day and remains in force on IP completion day (whether or not it is suspended); and

(c)was used by P to distribute a medicinal product, which was imported from an EEA State, by way of wholesale dealing, or to possess a medicinal product imported from an EEA State for such a purpose,

is deemed on and after IP completion day to hold a wholesale dealing licence granted under Part 3 (manufacture and distribution of medicinal products and active substances) that permits the operation of importing medicinal products from an approved country for import for the purposes specified in paragraph (c).

(2) After the end of the period of 6 months beginning with IP completion day, P is deemed to continue hold a wholesale dealer's licence that permits the operation of importing medicinal products from an approved country for import by virtue of sub-paragraph (1) only if, before the end of that period, P has notified the licensing authority in writing of—

(a)P's intention to continue to import medicinal products from an approved country for import; and

(b)either—

(i)P's intention to appoint a responsible person (import) who will carry out the functions under regulation 45AA(4) (requirement as to responsible persons where licence holder imports from an approved country for import) in respect of the licence, or

(ii)that P will only import medicinal products from an approved country for import to which an exemption in regulation 45AA(2) applies.

(3) Unless P has notified the licensing authority as provided for in sub-paragraph (2)(b)(ii), after the end of the period of 2 years beginning with IP completion day, P is deemed to continue to hold a wholesale dealer's licence that permits the operation of importing medicinal products from an approved country for import by virtue of sub-paragraph (1) only if, before the end of that period, P has notified the licensing authority in writing of the name, address and qualifications of a person who—

(a)is included in the register under regulation 45AB(1); and

(b)will carry out the functions under regulation 45AA(4) in respect of the licence.

(4) From IP completion day, until the date on which P notifies the licensing authority of the information specified in sub-paragraph (3), the responsible person in respect of that licence under regulation 45 must carry out the functions under regulation 45AA(4).

(5) As soon as reasonably practicable after receipt of the information specified in paragraph (3), the licensing authority must provide P with written notice that the responsible person (import) is named on the licence.

(6) Where P has notified the licensing authority as provided for in sub-paragraph (2)(b)(ii), the licensing authority must, as soon as reasonably practicable, notify P in writing that the wholesale dealer's licence includes import of a medicinal product from an approved country for import limited to medicinal products to which an exemption in regulation 45AA(2) applies.

Approved country for import list on IP completion day (regulation 18A)U.K.

3.—(1) For the purposes of regulation 18A(1) (approved country for import), during the transitional period, the licensing authority must publish an approved country for import list that includes each EEA State in it.

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 18A(3) to remove an EEA State from the approved country for import list.

(3) In this paragraph, “the transitional period” is the period of two years beginning with IP completion day.

Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)U.K.

4.—(1) Sub-paragraph (2) applies to a person who—

(a)is acting as a qualified person immediately before IP completion day; and

(b)satisfies the requirements of Part 1 of Schedule 7 (qualification requirements for qualified persons) immediately before IP completion day as they had effect at that time.

(2) The person is to be treated on and after IP completion day as continuing to satisfy the requirements of Part 1 of Schedule 7 if the person would otherwise fail to do so as a result of amendments made to that Part by the EU Exit Regulations.

(3) For the purposes of paragraph 14(1)(b) of Schedule 7 (obligations of qualified person), for the transitional period, the licensing authority is deemed to have made appropriate arrangements with—

(a)each EEA State;

(b)Australia;

(c)Canada;

(d)Israel;

(e)Japan;

(f)New Zealand;

(g)Switzerland; and

(h)the United States of America,

and the licensing authority must, on IP completion day, publish a list that includes those countries under paragraph 14(3) of Schedule 7.

(4) The licensing authority may, in respect of any country specified in sub-paragraph (3)(b) to (h), include that country in the list subject to a condition or restriction as provided for in paragraph 14(4) of Schedule 7, insofar as that condition or restriction was reflected in the appropriate arrangements that existed immediately before IP completion day under Article 51(2) of the 2001 Directive.

(5) The licensing authority must not, before the end of the transitional period, exercise its powers under paragraph 14(6) of Schedule 7 to remove an EEA State from the list it publishes.

(6) In this regulation, “the transitional period” is the period of two years beginning with IP completion day.

List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))U.K.

5.—(1) For the purposes of regulation 45O(6) (requirements for registration as an importer, manufacturer or distributor of active substances), for the transitional period, the licensing authority must publish a list that includes the following countries—

(a)each EEA State;

(b)Australia;

(c)Brazil;

(d)Israel;

(e)Japan;

(ea)Republic of Korea;

(f)Switzerland; and

(g)the United States of America.

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 45O(9) to remove an EEA State from the list it publishes.

(3) In this paragraph, “the transitional period” is the period of two years beginning with IP completion day.

PART 3U.K.Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day

Conversion of EU marketing authorisations in force before IP completion dayU.K.

6.—(1) This paragraph applies in relation to an EU marketing authorisation which was in force immediately before IP completion day.

(2) An EU marketing authorisation to which this paragraph applies—

(a)insofar as it authorises sale or supply of a medicinal product in Great Britain, has effect on and after IP completion day as a UKMA(GB) granted under regulation 49(1) of these Regulations (but, insofar as it authorises sale or supply of a medicinal product in Northern Ireland, continues to operate in Northern Ireland as an EU marketing authorisation); and

(b)is referred to in this Part as a “converted EU marketing authorisation”.

(3) If the holder of an EU marketing authorisation to which this paragraph applies notifies the licensing authority in writing before the end of the period of 21 days beginning with IP completion day that it does not wish to be the holder of a converted EU marketing authorisation, the licensing authority must revoke the converted EU marketing authorisation with effect from the date of receipt of the notification.

(4) A converted EU marketing authorisation—

(a)is treated as if it had been granted by the licensing authority under regulation 49(1) on the same terms as those on which the EU marketing authorisation was granted, including any conditions or restrictions subject to which the EU marketing authorisation was granted and which remain in force immediately before IP completion day;

(b)is treated, for the purposes of regulations 65 or 65B (validity of UK marketing authorisation), as if it had been granted by the licensing authority on the date that the EU marketing authorisation took effect;

(c)is treated for the purposes of regulation 67(1) (failure to place on the market) as if it had been granted on IP completion day, and the period of three years referred to in regulation 67(2) is treated as having started on IP completion day;

(d)is treated for the purposes of determining the relevant fee period for the purposes of Schedule 4 to the Fees Regulations (periodic fees for marketing authorisations) as if it had been granted by the licensing authority on the date that the EU marketing authorisation took effect;

(e)is treated, for the purposes of the reference to the date of grant in regulation 27A(a) of the Fees Regulations (fees for renewals of a marketing authorisation) as if it had been granted on the date that the EU marketing authorisation took effect;

(f)retains, for the purposes of regulation 51A(1) and (6), the benefit of any remaining periods of data or marketing exclusivity (if any) from which the holder benefitted immediately before IP completion day;

(g)retains the benefit of any decision by the EMA to exempt the holder from Articles 14(4) or (5) of Regulation (EC) No 726/2004 (failure to place on the market), and that decision is treated as if it had been made by the licensing authority under regulation 67(3); and

(h)remains subject to—

(i)any suspension of the EU marketing authorisation that is in force immediately before IP completion day,

(ii)any post-authorisation obligations imposed after it was granted, and which remain in force immediately before IP completion day, and

(iii)any variation to its terms which were granted or accepted before IP completion day.

(5) For the purposes of this paragraph, an EU marketing authorisation is in force, even if that authorisation is suspended immediately before IP completion day.

(6) A converted EU marketing authorisation to which this paragraph applies which—

(a)was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006; and

(b)remains such a conditional marketing authorisation immediately before IP completion day,

has effect on and after IP completion day as a UK marketing authorisation granted under regulation 58F.

(7) A converted EU marketing authorisation to which this paragraph applies which relates to a medicinal product which—

(a)was designated as an orphan medicinal product by the European Commission pursuant to Article 5 of the Orphan Regulation; and

(b)remains in the Community register of Orphan Medicinal Products as referred to in that Article immediately before IP completion day,

has effect on and after IP completion day as a UK marketing authorisation granted under regulation 58C and retains, for the purposes of regulation 58D, the benefit of any period of marketing exclusivity from which the holder benefitted immediately before IP completion day under Article 8 of the Orphan Regulation.

Classification of converted EU marketing authorisationsU.K.

7.  For the purposes of regulation 62 (classification of UK marketing authorisation), it is a term of a converted EU marketing authorisation that the product to which the authorisation relates is to be available—

(a)in a case where the product was classified in its EU marketing authorisation immediately before IP completion day as a prescription only medicine, the product is to be available only on prescription;

(b)in a case where the product was not so classified and the licensing authority has determined that the product should be available on general sale, the product is to be available on general sale; or

(c)in any other case, the product is to be available only from a pharmacy.

Obligations of licensing authority in connection with converted EU marketing authorisationsU.K.

8.—(1) The licensing authority must, before the end of the period of 7 days beginning with IP completion day, notify the holders of converted EU marketing authorisations—

(a)that the EU marketing authorisation is converted to a UK marketing authorisation; and

(b)that the holder may notify the licensing authority in accordance with paragraph 6(3) that it does not wish to be the holder of a UK marketing authorisation.

(2) The licensing authority must, as soon as reasonably practicable after the end of the period referred to in paragraph 6(3), publish a list of converted EU marketing authorisations.

(3) The list mentioned in sub-paragraph (2) must specify which converted EU marketing authorisations have been revoked in accordance with paragraph 6(3).

Obligations of holders of converted EU marketing authorisationsU.K.

9.—(1) A holder of a converted EU marketing authorisation must submit to the licensing authority, before the end of the period of one year beginning with IP completion day, the information described in sub-paragraph (3).

(2) The obligation in sub-paragraph (1) is subject to any requirement imposed by the licensing authority to provide that information before the end of a shorter period specified by the licensing authority under paragraph 10(1).

(3) The information which must be submitted in accordance with sub-paragraph (1) (referred to in this paragraph as the “baseline data”) is—

(a)such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing for this purpose and published by the licensing authority on or before IP completion day;

(b)notification of whether or not the product to which the converted EU marketing authorisation relates—

(i)is on the market in the United Kingdom at the time the notification is given, or

(ii)if not, whether the product has been on the market in the United Kingdom at any time on or after IP completion day and if so, the date on which it was withdrawn from the United Kingdom market.

(4) In this Part, the date on which the holder of a converted EU marketing authorisation complies with the obligation in sub-paragraph (1), or with any requirement imposed by the licensing authority under paragraph 10(1) to provide all of the baseline data before the end of a period shorter than the period of one year beginning with IP completion day, is referred to as “the data submission date”.

Powers of licensing authority in connection with provision of informationU.K.

10.—(1) If the licensing authority requests a holder of a converted EU marketing authorisation to submit all or part of the baseline data at any time before the expiry of the period of one year beginning with IP completion day, the holder must supply the information within the time period specified by the licensing authority in its request.

(2) If the licensing authority requests a holder of a converted EU marketing authorisation to provide any other information relating to the EU marketing authorisation, the holder must supply the information within the time period specified by the licensing authority in its request.

Variations of converted EU marketing authorisations notified or applied for before IP completion dayU.K.

11.—(1) This paragraph applies where, before IP completion day—

(a)a holder of a converted EU marketing authorisation has notified the EMA of, or made an application to the EMA for, a variation of the EU marketing authorisation to which the converted EU marketing authorisation applies under Chapter III of Regulation (EC) No 1234/2008, or has made an application to the EMA for an extension of that EU marketing authorisation in accordance with Article 19 of that Regulation;

(b)the procedures specified in Article 17 of that Regulation (measures to close the procedures of Articles 14 to 16) have not concluded, or, in the case of an extension, no final decision has been made by the European Commission in relation to the application; and

(c)the holder of the converted EU marketing authorisation wishes the variation to be made to the converted EU marketing authorisation.

(2) Where the variation is a minor variation of Type IA—

(a)the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b)the holder of the converted EU marketing authorisation must (subject to paragraph 13), include in the baseline data—

(i)a summary of the variation, and

(ii)if the notification has been rejected by the EMA, an indication of that fact; and

(c)the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing before the end of the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(3) Where the variation is a minor variation of Type IB—

(a)the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b)if the variation has not been rejected by the EMA, the holder of the converted EU marketing authorisation must (subject to paragraph 13) include a copy of the notification in the baseline data; and

(c)the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing before the end of the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(4) Sub-paragraph (5) applies where—

(a)the variation is a major variation of Type II or an extension; and

(b)before IP completion day the Committee for Medicinal Products for Human Use gave a positive final opinion in relation to the application with which the United Kingdom concurred.

(5) Where this sub-paragraph applies—

(a)the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b)the holder of the converted EU marketing authorisation must (subject to paragraph 13) include a copy of the application in the baseline data; and

(c)the licensing authority must either—

(i)treat the variation as accepted, and, if the variation affects the terms of the converted EU marketing authorisation, amend those terms accordingly; or

(ii)notify the holder of the converted EU marketing authorisation before the end of the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(6) Sub-paragraph (7) applies where—

(a)the variation is a major variation of Type II or an extension; and

(b)before IP completion day the Committee for Medicinal Products for Human Use had not given any opinion in relation to the application, or had given a negative final opinion in relation to it, or had given a positive final opinion but the United Kingdom recorded a divergent opinion.

(7) Where this paragraph applies—

(a)the holder of the converted EU marketing authorisation must submit to the licensing authority—

(i)the application for the variation; and

(ii)(subject to paragraph 13) the baseline data; and

(b)the licensing authority must consider the application in accordance with Schedule 10A.

(8) In this paragraph and paragraph 12, “minor variation of Type IA”, “minor variation of Type IB”, “major variation of Type II” and “extension” have the meanings given in paragraph 1 of Schedule 10A.

Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission dateU.K.

12.—(1) This paragraph applies where a holder of a converted EU marketing authorisation—

(a)notifies the EMA of, or applies to the EMA for, a variation of the EU marketing authorisation to which the converted EU marketing authorisation relates during the period beginning with IP completion day and ending on the day before the data submission date; and

(b)wishes the variation to be made in relation to the converted EU marketing authorisation.

(2) Where the variation is a minor variation of Type IA—

(a)the variation may be implemented in relation to the converted EU marketing authorisation at the same time as it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b)the holder of the converted EU marketing authorisation must (subject to paragraph 13), include in the baseline data—

(i)a summary of the variation, and

(ii)if the notification has been rejected by the EMA, an indication of that fact; and

(c)the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(3) Where the variation is a minor variation of Type IB, a major variation of Type II or an extension which has not been rejected by the EMA—

(a)the holder of the converted EU marketing authorisation must submit to the licensing authority—

(i)the notification of, or application for, the variation, and

(ii)(subject to paragraph 13) the baseline data; and

(b)the licensing authority must consider the application in accordance with Schedule 10A.

Variations of converted EU marketing authorisations sought in advance of the data submission dateU.K.

13.—(1) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a notification of, or an application for, a variation to the authorisation before the data submission date, the holder must—

(a)submit the notification or application to the licensing authority; and

(b)unless sub-paragraph (2) applies, provide to the licensing authority at the same time such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a notification of, or an application for, a variation to the authorisation before the data submission date but does not provide the information described in sub-paragraph (1)(b) with the notification or application, the licensing authority may agree to consider the notification or application if it is satisfied that—

(a)the variation may be necessary on urgent safety grounds;

(b)the variation may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(c)there are other good reasons for considering the variation in advance of the submission of the information described in sub-paragraph (1).

(3) Where the licensing authority considers a notification of, or an application for, a variation in advance of the data submission date in accordance with this paragraph, the references in paragraphs 11(2)(c), (3)(c) and (5)(c)(ii) and 12(2)(c) to the data submission date are to be read as references to the date on which—

(a)the notification of, or the application for, the variation is submitted to the licensing authority in accordance with sub-paragraph (1); or

(b)the licensing authority notifies the holder that it will consider the notification or application, in accordance with sub-paragraph (2), without the information referred to in sub-paragraph (2)(b).

Applications for renewals of converted EU marketing authorisations made before IP completion dayU.K.

14.—(1) This paragraph applies where a holder of a converted EU marketing authorisation has, before IP completion day, made an application to the EMA for renewal of the EU marketing authorisation in accordance with Article 14 of Regulation (EC) No 726/2004 but no final decision has been made in relation to that application by the European Commission before IP completion day.

(2) Where this paragraph applies—

(a)the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the application for renewal to the licensing authority with the baseline data; and

(b)the licensing authority must—

(i)where before IP completion day the Committee for Medicinal Products for Human Use has given a positive final opinion in relation to the application with which the United Kingdom concurred, treat the renewal application as accepted for the purposes of regulation 66 (application for renewal of authorisation), or

(ii)where before IP completion day the Committee for Medicinal Products for Human Use has not given any opinion or has given a negative final opinion in relation to the application, or where a positive final opinion has been given but the United Kingdom recorded a divergent opinion, treat the application as an application made in relation to the converted EU marketing authorisation under regulation 66 and consider the application in accordance with that regulation.

Applications for renewals of conditional marketing authorisations made before IP completion dayU.K.

15.—(1) This paragraph applies where before IP completion day—

(a)a holder of a converted EU marketing authorisation which was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006 has made an application to the EMA for renewal of the authorisation in accordance with Article 6 of that Regulation; but

(b)no final decision has been made in relation to that application by the European Commission.

(2) Where this paragraph applies—

(a)the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the application for renewal to the licensing authority with the baseline data; and

(b)the licensing authority must—

(i)where before IP completion day the Committee for Medicinal Products for Human use has given a positive final opinion in relation to the application with which the United Kingdom concurred, treat the renewal application as accepted for the purposes of regulation 66B, or

(ii)where before IP completion day the Committee for Medicinal Products for Human Use has not given any opinion or has given a negative final opinion in relation to the application, or where a positive final opinion has been given but the United Kingdom recorded a divergent opinion, treat the application as an application made in relation to the converted EU marketing authorisation under regulation 66B (renewal of conditional marketing authorisation) and consider the application in accordance with that regulation.

Applications for renewals of converted EU marketing authorisations made after IP completion dayU.K.

16.—(1) This paragraph applies where a holder of a converted EU marketing authorisation is due to make an application for renewal of the authorisation in accordance with regulation 66 (application for renewal of authorisation) during the period of one year beginning with IP completion day.

(2) Where this paragraph applies—

(a)the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the baseline data so that it is received by the licensing authority at the same time as the application for renewal is made;

(b)the licensing authority must consider the renewal application in accordance with regulation 66; and

(c)the converted EU marketing authorisation remains in force until the licensing authority notifies the holder of its decision on the renewal application.

Applications for renewals of conditional marketing authorisations made after IP completion dayU.K.

17.—(1) This paragraph applies where the holder of a converted EU marketing authorisation which was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006 is due to make an application for renewal of the authorisation in accordance with regulation 66B during the period beginning with IP completion day and ending on the data submission date.

(2) Where this paragraph applies—

(a)the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the baseline data so that it is received by the licensing authority at the same time as the application for renewal is made;

(b)the licensing authority must consider the renewal application in accordance with regulation 66B (renewal of conditional marketing authorisation); and

(c)the authorisation remains in force until the licensing authority notifies the holder of its decision on the renewal application.

Renewals of converted EU marketing authorisations sought in advance of the data submission dateU.K.

18.—(1) If a holder of a converted EU marketing authorisation submits an application for renewal in accordance with regulation 66 or 66B before the data submission date, it must, unless sub-paragraph (2) applies, provide to the licensing authority with the application such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a renewal application before the data submission date but does not provide the information described in sub-paragraph (1) with the application, the licensing authority may agree to consider the application if it is satisfied that—

(a)the renewal may be necessary on urgent safety grounds;

(b)the renewal may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(c)there are other good reasons for considering the renewal in advance of the data submission date.

Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisationsU.K.

19.—(1) This paragraph applies where, before IP completion day—

(a)a holder of a converted EU marketing authorisation has, in accordance with Article 61(3) of the 2001 Directive, notified the EMA of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates; but

(b)the period of 90 days referred to in Article 61(3) has not elapsed and the EMA has not objected to the proposed change.

(2) Where this paragraph applies, and where the holder wishes the proposed change to apply in relation to the converted EU marketing authorisation—

(a)the holder may put the change into effect in relation to the converted EU marketing authorisation at the same time as it may be put into effect in relation to the EU marketing authorisation;

(b)the holder must (subject to paragraph 21) include with the baseline data—

(i)a copy of the notification, and

(ii)an indication of whether the EMA has opposed the proposed change; and

(c)the proposed change to the labelling or the package leaflet of the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the proposed change is opposed, in which case the holder must cease to apply the opposed change immediately after receipt of the notification.

Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission dateU.K.

20.—(1) This paragraph applies where, during the period beginning with IP completion day and ending on the day before the data submission date, a holder of a converted EU marketing authorisation notifies the EMA in accordance with Article 61(3) of the 2001 Directive of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates.

(2) Where this paragraph applies, and where the holder wishes the proposed change to apply in relation to the converted EU marketing authorisation—

(a)the holder of the converted EU marketing authorisation may put the change into effect at the same time as it may be put into effect in relation to the EU marketing authorisation;

(b)the holder must (subject to paragraph 21) include with the baseline data—

(i)a copy of the notification, and

(ii)an indication of whether the EMA has opposed the proposed change; and

(c)the proposed change to the labelling or the package leaflet of the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the proposed change is opposed, in which case the holder must cease to apply the opposed change immediately after receipt of the notification.

Article 61(3) notifications sought in advance of the data submission dateU.K.

21.—(1) If a holder of a converted EU marketing authorisation wishes to notify the licensing authority of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates in advance of the data submission date, the holder must—

(a)submit the notification of the proposed change to the licensing authority; and

(b)unless sub-paragraph (2) applies, at the same time provide the licensing authority with such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a proposed change before the data submission date but does not provide the information described in sub-paragraph (1)(b) with the notification, the licensing authority may agree to consider the notification if it is satisfied that—

(a)the proposed change may be necessary on urgent safety grounds;

(b)the proposed change may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(c)there are other good reasons for considering the proposed change in advance of the data submission date.

(3) Where the licensing authority considers a proposed change in accordance with this paragraph, the references in paragraph 19(2)(c) and 20(2)(c) to the data submission date are to be read as references to the date on which—

(a)the proposed change is notified to the licensing authority in accordance with sub-paragraph (1); or

(b)the licensing authority notifies the holder that it will consider the notification, in accordance with sub-paragraph (2), without the information referred to in sub-paragraph (1)(b).

Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion dayU.K.

22.—(1) Subject to sub-paragraph (2), a person who—

(a)holds a converted EU marketing authorisation on IP completion day (whether or not it is suspended); and

(b)was, immediately before IP completion day, established in an EEA State, and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3) or 66(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person after the end of the specified period only if the person has, before the end of that period, notified the licensing authority in writing of—

(a)a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the converted EU marketing authorisation during the transitional period; and

(b)that individual's address, telephone number and email address.

(3) In this paragraph—

“the specified period” means 4 weeks beginning with IP completion day; and

“the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements for converted EU marketing authorisationsU.K.

23.—(1) A holder of a converted EU marketing authorisation does not commit an offence under regulation 268 during the period of 36 months beginning with IP completion day to the extent that—

(a)the packaging and package leaflet do not comply with the requirements of Part 13 by reason only of the fact that the outer or immediate packaging, or the package leaflet, do not include the correct information as to—

(i)the name and address of the holder of the UK marketing authorisation, or, where applicable, the name of the holder's representative,

(ii)the number of the UK marketing authorisation, or

(iii)the name and address of the manufacturer of the product; and

(b)the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i)the number of the marketing authorisation is the number of the EU marketing authorisation to which the converted EU marketing authorisation relates, or

(ii)the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and the information specified in paragraph (a)(i) or (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a)the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b)the holder of the converted EU marketing authorisation, having been notified of the number of the UK marketing authorisation and having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, during the period referred to in sub-paragraph (1).

Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion dayU.K.

24.—(1) Sub-paragraph (2) applies where—

(a)the European Commission has requested the opinion of the EMA in accordance with Article 20(2) of Regulation (EC) No 726/2004 in relation to a specified matter; but

(b)no final decision has been adopted by the European Commission in accordance with Article 20(3) of that Regulation immediately before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 (revocation, variation and suspension of UK marketing authorisation) as soon as reasonably practicable.

(3) In making a decision under regulation 68 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in the procedure under Article 20 of Regulation (EC) No 726/2004;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member State in the making of that decision or agreement, under any procedure provided for in the Council Decision of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the Commission; and

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11.

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use has given a final opinion in relation to the specified matter.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11.

(6) Sub-paragraph (7) applies where—

(a)the European Commission has requested the opinion of the EMA in accordance with Article 20(2) of Regulation (EC) No 726/2004 in relation to a specified matter;

(b)a final decision has been adopted by the European Commission in accordance with Article 20(3) of that Regulation immediately before IP completion day; but

(c)the necessary steps to give effect to the decision referred to in paragraph (b) have not been taken before IP completion day.

(7) Where this sub-paragraph applies, the licensing authority must, where a Commission decision or opinion requires steps to be taken in respect of an EU marketing authorisation that is a converted EU marketing authorisation, take the steps necessary as a result of the decision or opinion to suspend, revoke or vary a converted EU marketing authorisation as soon as reasonably practicable.

(8) In this paragraph, “specified matter” means a matter in relation to which the opinion of the EMA has been requested by the European Commission under Article 20(2) of Regulation (EC) No 726/2004 before IP completion day that might result in the suspension, revocation or variation of an EU marketing authorisation which is a converted EU marketing authorisation.

EnforcementU.K.

25.  If a holder of a converted EU marketing authorisation fails to comply with an obligation imposed on the holder by or under this Part, the licensing authority may suspend the authorisation until the holder complies with the obligation.

PART 4U.K.Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices

Status of certain UK marketing authorisations granted before IP completion dayU.K.

26ZA.—(1) This paragraph applies in relation to a UK marketing authorisation granted by the licensing authority under Chapter 4 of Title III to the 2001 Directive that was in force immediately before IP completion day.

(2) A UK marketing authorisation to which this paragraph applies—

(a)has effect on and after IP completion day as a UKMA(UK) granted under regulation 49(1) of these Regulations; and

(b)is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion dayU.K.

26.—(1) Subject to sub-paragraphs (2) and (3), any person—

(a)who—

(i)holds a UK marketing authorisation immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii)holds a parallel import licence immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(iii)has made an application for, or to renew, a UK marketing authorisation or parallel import licence before IP completion day, which has not been determined before that date,

(iv)makes such an application on or after IP completion day but before the end of the transitional period; or

(v)is deemed to hold a parallel import licence under paragraph 28(2); and

(b)who was, immediately before IP completion day, established in an EEA State and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3), 66(2) or 66A(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person where the UK marketing authorisation or parallel import licence authorises sale or supply of the medicinal product in Great Britain only if the person has notified the licensing authority in writing of—

(a)a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the UK marketing authorisation or parallel import licence, or application for a UK marketing authorisation or parallel import licence (as the case may be), during the transitional period; and

(b)that individual's address, telephone number and email address.

(3) A person must notify the licensing authority under sub-paragraph (2)—

(a)where sub-paragraph (1)(a)(i) to (iii) applies, within the period of 4 weeks beginning with IP completion day; or

(b)where sub-paragraph (1)(a)(iv) applies, at the time of making the application.

(4) This paragraph does not apply to a UK marketing authorisation that is a converted EU marketing authorisation within the meaning of paragraph 6.

(5) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishmentU.K.

27.—(1) Subject to sub-paragraph (2), a person to whom paragraph 26 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a)the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

(i)the name and address of the holder of the UK marketing authorisation, or, where applicable, the name of that holder's representative,

(ii)the number of the UK marketing authorisation, or

(iii)the name and address of the manufacturer of the product; and

(b)the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i)the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and

(ii)the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a)the packaging and package leaflet met the requirements of Part 13 as to the matters specified in paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b)the UK marketing authorisation holder, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

Status of parallel import licences granted before IP completion dayU.K.

27A.—(1) This paragraph applies in relation to a parallel import licence granted by the licensing authority that was in force immediately before IP completion day.

(2) A parallel import licence to which this paragraph applies—

(a)has effect on and after IP completion day as a parallel import licence in force in the whole United Kingdom granted under regulation 49(1) of these Regulations; and

(b)is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

Conversion of parallel distribution notices in to parallel import licencesU.K.

28.—(1) Sub-paragraph (2) applies where—

(a)a person holds a parallel distribution notice, issued by the EMA, for a medicinal product in respect of which there is an EU marketing authorisation;

(b)that distribution notice, and that EU marketing authorisation, are in force immediately before IP completion day; and

(c)that parallel distribution notice specifies the United Kingdom as a member state of destination in respect of that medicinal product.

(2) Subject to sub-paragraph (3), a person who falls within sub-paragraph (1) is deemed, on and after IP completion day, to have a parallel import licence granted under Part 5, in force in Great Britain only, in respect of the medicinal product specified in the parallel distribution notice.

(3) A person who falls within sub-paragraph (1) continues to hold a parallel import licence pursuant to sub-paragraph (2) only if that person notifies the licensing authority—

(a)before the end of the period of 21 days beginning with IP completion day, of each medicinal product, and each country from which it is intended to import that product on or after IP completion day; and

(b)of any other information that the licensing authority requests, within such time period as the licensing authority may specify.

(4) The licensing authority must as soon as reasonably practicable after receipt of the information specified in sub-paragraph (3), issue a parallel import licence to the holder of the parallel distribution notice.

Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A)U.K.

29.—(1) Sub-paragraph (2) applies where—

(a)a marketing authorisation was in force before IP completion day,

(b)that authorisation is in force as a UK marketing authorisation on IP completion day (whether or not it is suspended); and

(c)that authorisation is for a medicinal product of a type that is specified in regulation 60A(2)(a) to (e) (condition as to the submitting of samples and other information to the appropriate authority).

(2) Where this sub-paragraph applies, the UK marketing authorisation is deemed to include the batch testing condition on and after IP completion day.

(3) Sub-paragraph (4) applies where a holder of a UK marketing authorisation has, before IP completion day, submitted to a competent authority of an EEA State samples for testing from a batch of a medicinal product (“the relevant batch”) that—

(a)is the subject of that authorisation; and

(b)is of a type specified in regulation 60A(2)(a) to (e).

(4) Where this sub-paragraph applies, the holder of the UK marketing authorisation is deemed to have satisfied the batch testing condition in respect of the relevant batch if, before IP completion day—

(a)the competent authority of that EEA State examines the sample from the relevant batch; and

(b)that authority declared it to be in conformity with the approved specifications (within the meaning of Article 114 of the 2001 Directive) before IP completion day.

(5) The appropriate authority—

(a)must include each EEA State on the list it publishes under regulation 60A(5) on IP completion day; and

(b)must not, before the end of the transitional period, exercise its powers under regulation 60A(8) to remove an EEA State from the list it publishes under regulation 60A(5).

(6) For the purposes of regulation 60A(9), the appropriate authority must, on IP completion day—

(a)include Switzerland and Israel in the list it publishes under that paragraph; and

(b)include in respect of those countries any conditions or restrictions in the arrangement with those countries that affect the applicability of the batch testing exemption.

(7) In this paragraph—

(a)“the transitional period” means the period of 24 months beginning with IP completion day; and

(b)“the batch testing condition” and “the batch testing exemption” have the same meaning as in regulation 60A.

(8) This paragraph, with the exception of sub-paragraphs (3) and (4), applies equally to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this paragraph (other than in this sub-paragraph) to—

(a)a marketing authorisation or a UK marketing authorisation is to be read as a reference to a parallel import licence for a medicinal product, and

(b)the holder of a UK marketing authorisation is to be read as a reference to the holder of a parallel import licence.

Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B)U.K.

29A.—(1) Sub-paragraph (2) applies where—

(a)an EU marketing authorisation was in force before IP completion day,

(b)that authorisation is in force on IP completion day (whether or not it is suspended); and

(c)that authorisation is for a medicinal product of a type that is specified in regulation 60B(2) (requirement to submit samples and other information to the appropriate authority).

(2) Where this sub-paragraph applies, the EU marketing authorisation is deemed to be subject to the batch testing requirement in regulation 60B on and after IP completion day.

(3) Sub-paragraph (4) applies where a holder of an EU marketing authorisation has, before IP completion day, submitted to a competent authority of an EEA State samples for testing from a batch of a medicinal product (“the relevant batch”) that—

(a)is the subject of that authorisation; and

(b)is of a type specified in regulation 60B(2).

(4) Where this sub-paragraph applies, the holder of the EU marketing authorisation is deemed to have satisfied the batch testing requirement in regulation 60B in respect of the relevant batch if, before IP completion day—

(a)the competent authority of that EEA State examines the sample from the relevant batch; and

(b)that authority declared it to be in conformity with the approved specifications (within the meaning of Article 114 of the 2001 Directive) before IP completion day.

(5) Sub-paragraphs (5) and (6) of paragraph 29 apply in relation to the appropriate authority’s management of the list published under regulation 60A(5) for the purposes of this paragraph and regulation 60B.

Existing data and marketing exclusivity and global marketing authorisationsU.K.

30.—(1) Sub-paragraph (2) applies in relation to a UK marketing authorisation which, immediately before IP completion day, is part of a global marketing authorisation with one or more EU marketing authorisations or marketing authorisations granted by the competent authority of an EEA state.

(2) Where this sub-paragraph applies, the provisions of regulation 48(5) (definitions for Part 5), in so far as they describe a global marketing authorisation by reference to UK marketing authorisations only, do not affect the periods of data and marketing exclusivity to which the holder of a UK marketing authorisation to which this paragraph applies is entitled immediately before IP completion day.

Applications for EU marketing authorisations made before IP completion dayU.K.

31.—(1) Sub-paragraph (2) applies where, before IP completion day—

(a)an application has been made to the EMA for an EU marketing authorisation; but

(b)no final decision has been made by the European Commission in relation to the grant of an EU marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2) Where this sub-paragraph applies, the applicant may apply to the licensing authority for the grant of a UK marketing authorisation by submitting to the licensing authority—

(a)a copy of the application for the EU marketing authorisation; and

(b)if requested by the licensing authority, such material or information that the licensing authority reasonably considers necessary for dealing with the application.

(3) Sub-paragraph (4) applies where, before IP completion day and in relation to an application to which sub-paragraph (2) applies, a final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use and the United Kingdom concurred with that opinion.

(4) Where this sub-paragraph applies, the licensing authority must grant a UK marketing authorisation in response to an application as described in sub-paragraph (2) as soon as reasonably practicable after it is received.

(5) Sub-paragraph (6) applies where before IP completion day, in relation to an application to which sub-paragraph (2) applies—

(a)no final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use; or

(b)such an opinion has been given but the United Kingdom recorded a divergent opinion.

(6) Where this sub-paragraph applies, the licensing authority must consider an application made under sub-paragraph (2) in accordance with Part 5 of these Regulations (marketing authorisations).

Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)U.K.

32.—(1) Subject to sub-paragraph (2), a person—

(a)who applied to the EMA for an EU marketing authorisation before IP completion day;

(b)to whom the licensing authority grants a UK marketing authorisation on or after IP completion day in response to that application in accordance with paragraph 31; and

(c)who was, immediately before IP completion day, established in an EEA State, and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) Sub-paragraph (1) applies to a person only if, when submitting a copy of the application for the EU marketing authorisation to the licensing authority in accordance with paragraph 31, the person notifies the licensing authority in writing of—

(a)a named individual who resides and operates in the United Kingdom whom the licensing authority may contact in respect of any matter relating to the UK marketing authorisation during the transitional period; and

(b)that individual's address, telephone number and email address.

(3) In this paragraph, “the transitional period” means the period which beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 24 months after IP completion day.

Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion dayU.K.

33.—(1) Subject to sub-paragraph (2), a person to whom paragraph 32(1) applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a)the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet, do not include the correct information as to—

(i)the name and address of the holder of the marketing authorisation, or, where applicable, the name of the holder's representative,

(ii)the number of the marketing authorisation, or

(iii)the name and address of the manufacturer of the product; and

(b)the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i)the number of the marketing authorisation is the number of the EU marketing authorisation to which the application for the EU marketing authorisation related, or

(ii)the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and the information specified in paragraph (a)(i) or (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a)the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b)the UK marketing authorisation holder, being aware of the number of the UK marketing authorisation and having established in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph, “the transitional period” means the period beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 36 months after IP completion day.

Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive appliedU.K.

34.—(1) Sub-paragraph (2) applies where an application for a UK marketing authorisation has been made before IP completion day and—

(a)regulation 58(6) and (7) of the 2012 Regulations (applications to be determined under Chapter 4 of Title III of the 2001 Directive) applied to that application before IP completion day; but

(b)a decision as specified in Article 28(5) of the 2001 Directive has not been adopted by the licensing authority before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)where the procedure specified in Article 28(4) of the 2001 Directive has concluded before IP completion day in relation to that application, grant a UK marketing authorisation in respect of that application as soon as reasonably practicable, and in any event before the end of the period of 30 days, beginning with IP completion day; or

(b)where the procedure specified in Article 28(4) of the 2001 Directive has not concluded before IP completion day, determine that application in accordance with Part 5 of these Regulations (marketing authorisations) as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they no longer want the application to proceed.

(3) In making a determination under sub-paragraph (2)(b), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the application as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a reference member state or concerned member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive; and

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) In making a determination under sub-paragraph (2)(b), the licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation in the time period specified in regulation 58(1) (consideration of application) as if it had applied to that application on the date on which the application was submitted.

Transitional provision in respect of Plasma Master FilesU.K.

35.—(1) This paragraph applies in relation to a UK marketing authorisation or EU marketing authorisation—

(a)which was granted before IP completion day;

(b)the application for which made reference to a Plasma Master File within the meaning of paragraph 1.1(a), first indent, of Part III of Annex I to the 2001 Directive which was certified by the EMA in accordance with paragraph 1.1(c) of that Part of the Annex; and

(c)which remains in force as a UK marketing authorisation on and after IP completion day.

(2) A holder of the UK marketing authorisation to which this paragraph applies may, subject to complying with the obligations in sub-paragraph (3), continue to refer to the Plasma Master File as certified by the EMA, notwithstanding the modifications to paragraph 1.1(c) of Part III of Annex I to the 2001 Directive in Schedule 8B, subject which that paragraph is to be read on and after IP completion day.

(3) The holder of a UK marketing authorisation to which this paragraph applies must notify the licensing authority of—

(a)the outcome of the annual update and recertification of the Plasma Master File by the EMA within 4 weeks beginning with the completion of that update and recertification;

(b)any application for changes to the terms of the Plasma Master File which the holder seeks from the EMA, within 4 weeks beginning with the date of the application; and

(c)the outcome of any application referred to in paragraph (b), within 4 weeks beginning with the date on which the holder is notified of that outcome.

(4) The licensing authority may at any time review the terms of a Plasma Master File to which reference is made in accordance with sub-paragraph (2), with a view to exercising its powers under these Regulations in relation to the UK marketing authorisation.

Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004U.K.

36.  Where, immediately before IP completion day, a marketing authorisation, which is a UK marketing authorisation on IP completion day, has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive or Regulation (EC) No 726/2004, the suspension—

(a)continues to have effect on and after IP completion day in accordance with the terms on which it was imposed; and

(b)is to be treated as if it had been imposed by the licensing authority under Part 5 (marketing authorisations).

Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion dayU.K.

37.—(1) Sub-paragraph (2) applies where—

(a)a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day; but

(b)that procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 (revocation, variation and suspension of UK marketing authorisation) as soon as reasonably practicable.

(3) In making a decision under regulation 68 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive; and

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11.

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use or the Co-ordination Group for Mutual Recognition and Decentralised Procedures (as the case may be) has given a final opinion in relation to the matter referred under Article 31 of the 2001 Directive.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11 (advice and representations).

(6) Sub-paragraph (7) applies where—

(a)a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day;

(b)that referral has concluded before IP completion day; but

(c)the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(7) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the UK marketing authorisation—

(a)as soon as reasonably practicable; and

(b)in the case of a UK marketing authorisation that is not a converted EU marketing authorisation, within the period specified in Article 34(3) of the 2001 Directive (if relevant).

(8) In this paragraph—

“concluded before IP completion day”, in relation to an Article 31 referral, means—

(a)

a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or

(b)

an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and

“specified matter” means—

(a)

a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a UK marketing authorisation or an EU marketing authorisation; but

(b)

does not include a referral made under Article 107i of the 2001 Directive.

PART 5U.K.Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations

Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)U.K.

38.—(1) Sub-paragraph (2) applies where—

(a)an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day; but

(b)the procedures specified in Article 13e of that Regulation (measures to close the variation procedures in Chapter IIa of that Regulation) have not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day;

(b)assess the application or notification in accordance with the provisions of that Schedule the authority has determined are relevant to the application, as if the application or notification had been made under them; and

(c)take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

(3) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1)(a) or (b).

Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive)U.K.

39.—(1) This paragraph applies where an application or notification in respect of a variation to a marketing authorisation has been submitted to the licensing authority, as a relevant authority, under Chapter II of Regulation (EC) No 1234/2008 before IP completion day.

(2) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have not concluded before IP completion day, the licensing authority must—

(a)assess the application or notification in accordance with regulation 65C and Schedule 10A to these Regulations, as if the application or notification had been made under those provisions; and

(b)make such an assessment having regard to the matters specified in sub-paragraph (5).

(3) If the procedures specified in Article 11(1) of Regulation (EC) No 1234/2008 have concluded before IP completion day—

(a)the licensing authority must take the steps specified in Article 11(2) of Regulation (EC) No 1234/2008 within the time limit specified in Article 23(1) of that Regulation; and

(b)paragraphs 15 and 16 of Schedule 10A apply to the variation.

(4) In making a determination under sub-paragraph (2), the licensing authority must—

(a)determine which steps of the procedures specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the matters specified in sub-paragraph (5); and

(b)take all reasonable steps to ensure that it assesses the notification or application in accordance with any time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

(5) In making a determination under sub-paragraph (2), the licensing authority must have regard to—

(a)any recommendation in relation to that application or notification given before IP completion day pursuant to Article 5 of Regulation (EC) No 1234/2008;

(b)any relevant information obtained by it before IP completion day, as a relevant authority, in relation to the application or notification by virtue of any procedure provided for in Chapter II of that Regulation; and

(c)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority, including any matter referred under the procedure specified in Article 13 of that Regulation.

Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)U.K.

40.—(1) Sub-paragraph (2) applies where—

(a)an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority, as a relevant authority or the reference authority, under Article 20 of Regulation (EC) No 1234/2008;

(b)the marketing authorisation is one to which Chapter II or IIa of that Regulation applied; and

(c)the procedure in Article 20(8) has not been completed before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Article 20 of Regulation (EC) No 1234/2008 before IP completion day;

(b)assess the application or notification in accordance with the relevant provisions in that Schedule, as if the application or notification had been made under them; and

(c)take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.

(3) In making a determination or assessment under sub-paragraph (2), the licensing authority must have regard to—

(a)any opinion given by the reference authority before IP completion day in relation to that application;

(b)any relevant information obtained by it before IP completion day, as a reference authority or relevant authority, in relation to the application or notification by virtue of any procedure provided for in regulation 20 of Regulation (EC) No 1234/2008; and

(c)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a relevant authority.

(4) Paragraphs 15 and 16 of Schedule 10A apply to any variation that falls under sub-paragraph (1).

PART 6U.K.Transitional provision in relation to the Paediatric Regulation

Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric RegulationU.K.

41.—(1) Where a paediatric investigation plan has been agreed by the EMA in accordance with the Paediatric Regulation before IP completion day, that plan, including any modifications agreed by the EMA before IP completion day, has effect on and after IP completion day as an agreed paediatric investigation plan.

(2) Sub-paragraph (3) applies where—

(a)a paediatric investigation plan has been submitted to the EMA with a request for agreement before IP completion day;

(b)the proposed paediatric plan is valid in accordance with the provisions of Article 15(2) of the Paediatric Regulation; but

(c)the EMA has not adopted a decision to agree the plan before IP completion day.

(3) Where this sub-paragraph applies, the licensing authority must—

(a)where an opinion favourable to agreeing the paediatric investigation plan has been given by the Paediatric Committee before IP completion day, treat the plan as an agreed paediatric investigation plan;

(b)where an opinion against agreeing the paediatric investigation plan has been given by the Paediatric Committee before IP completion day, decide that it cannot agree the plan under regulation 50B(5) (agreement and modification of paediatric investigation plan); or

(c)where before IP completion day no opinion in relation to the paediatric investigation plan has been given by the Paediatric Committee treat it as a request for agreement under regulation 50B(1) and determine that request as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they do not want the application to proceed as a request for agreement of a paediatric investigation plan under these Regulations.

(4) Sub-paragraph (5) applies where—

(a)a paediatric investigation plan has been agreed by the EMA in accordance with the Paediatric Regulation before IP completion day;

(b)the person to whom the EMA's decision to agree the plan was addressed has, before IP completion day, made a proposal under Article 22 of the Paediatric Regulation to modify the plan, or to request a waiver; but

(c)the EMA has not adopted a decision to agree to the modification or waiver before IP completion day.

(5) Where this sub-paragraph applies, the licensing authority must—

(a)where an opinion favourable to agreeing the modification or waiver has been given by the Paediatric Committee before IP completion day, agree to the modification or waiver as if it had been requested under regulation 50B(6);

(b)where an opinion against agreeing the modification or waiver has been given by the Paediatric Committee before IP completion day, decide that it cannot agree to the modification or waiver as if it had been requested under regulation 50B(6); or

(c)where before IP completion day no opinion in relation to the modification or waiver has been given by the Paediatric Committee treat the proposal as one made under regulation 50B(6) and consider it accordingly, unless the applicant notifies the licensing authority in writing that they do not want the proposal to proceed as a proposal under regulation 50B(6).

(6) Where the EMA has adopted a decision to grant, and has not revoked, a waiver of the obligation to produce the information in Article 7(1)(a) of the Paediatric Regulation before IP completion day, that waiver has effect on and after IP completion day as a waiver granted by the licensing authority under regulation 50D (waiver of production of information in a paediatric investigation plan).

(7) Sub-paragraph (8) applies where—

(a)an application has been made to the EMA for a waiver of the obligation to produce the information in Article 7(1)(a) of the Paediatric Regulation before IP completion day;

(b)the application has been accepted as valid by the EMA; but

(c)the EMA has not adopted a decision to grant the waiver before IP completion day.

(8) Where this sub-paragraph applies, the licensing authority must—

(a)where an opinion favourable to agreeing the waiver has been given by the Paediatric Committee before IP completion day, grant the waiver under regulation 50D(2);

(b)where an opinion against agreeing the waiver has been given by the Paediatric Committee before IP completion day, decide that it cannot grant the waiver under regulation 50D(2); or

(c)where before IP completion day no opinion in relation to the waiver has been given by the Paediatric Committee treat the proposal as one made under regulation 50D and consider it accordingly, unless the applicant notifies the licensing authority in writing that they do not want the proposal to proceed as a proposal under regulation 50D.

Transitional provision in relation to global marketing authorisations under the 2001 DirectiveU.K.

41A.  Where a relevant medicinal product is subject to a global marketing authorisation as described in Article 6 of the 2001 Directive before IP completion day, a paediatric investigation plan does not need to be carried out in relation to that product.

PART 8U.K.Transitional provision in respect of homoeopathic medicinal products

List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion dayU.K.

43.—(1) For the purposes of the definition of “homoeopathic medicinal product” in regulation 8 (general interpretation: accepted Pharmacopoeias for homoeopathic manufacturing procedures), during the transitional period, the licensing authority must publish a list of countries that includes each EEA State in it.

(2) The licensing authority must not, before the end of the transitional period, remove an EEA State from the list described in sub-paragraph (1).

(3) In this paragraph, “the transitional period” is the period of two years beginning with IP completion day.

Place of establishment for holders of certificates of registration established in EEA before IP completion dayU.K.

44.—(1) Subject to sub-paragraph (2), any person—

(a)who—

(i)holds a certificate of registration immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii)has made an application for, or to renew, a certificate of registration before IP completion day, which has not been determined by the licensing authority before that date, or

(iii)makes such an application on or after IP completion day but before the end of the transitional period; and

(b)who was, immediately before IP completion day, established in an EEA State and who remains there on and after that day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 103(4) or 108(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person, in relation to a certificate of registration in force in Great Britain, only if the person has notified the licensing authority in writing of—

(a)a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the certificate of registration, or application for a certificate of registration, during the transitional period; and

(b)that individual's address, telephone number and email address.

(3) A person must notify the licensing authority under sub-paragraph (2)—

(a)where sub-paragraph (1)(a)(i) or (ii) applies, within the period of 4 weeks beginning with IP completion day; or

(b)where sub-paragraph (1)(a)(iii) applies, at the time of making the application.

(4) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishmentU.K.

45.—(1) Subject to sub-paragraph (2), a person to whom paragraph 44 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain) during the transitional period in relation to a product to the extent that—

(a)the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

(i)the name and address of the holder of the certificate of registration,

(ii)the number of the certificate of registration, or

(iii)the name and address of the manufacturer of the product if different from the holder of the certificate of registration; and

(b)the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i)the holder of the certificate of registration has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 103(4) or 108(2), and

(ii)the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a)the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b)the certificate of registration holder, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive appliedU.K.

46.—(1) Sub-paragraph (2) applies where an application for a certificate of registration has been made before IP completion day and—

(a)regulation 104(5) and (6) (applications to be determined under Chapter 4 of Title III of the 2001 Directive) applied to that application before IP completion day; but

(b)a decision as specified in Article 28(5) of the 2001 Directive has not been adopted by the licensing authority before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)where the procedure specified in Article 28(4) of the 2001 Directive has concluded before IP completion day in relation to that application, grant a certificate of registration in respect of that application as soon as reasonably practicable, and in any event before the end of the period of 30 days, beginning with IP completion day; or

(b)where the procedure specified in Article 28(4) of the 2001 Directive has not concluded before IP completion day, determine that application in accordance with Part 6 of these Regulations as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they no longer want the application to proceed.

(3) In making a determination under sub-paragraph (2)(b), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the application as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive; and

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a reference member state or concerned member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive.

(4) In making a determination under sub-paragraph (2)(b), the licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a certificate of registration in the time period specified in regulation 104(1) as if it had applied to that application on the date on which the application was submitted.

Suspensions of certificates of registration that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 DirectiveU.K.

47.  Where, immediately before IP completion day, a certificate of registration has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive, the suspension—

(a)continues to have effect on and after IP completion day in accordance with the terms on which it was imposed; and

(b)is to be treated as if it had been imposed by the licensing authority under Part 6 of these Regulations (certification of homoeopathic medicinal products).

Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a certificate of registration that have not concluded before IP completion dayU.K.

48.—(1) Sub-paragraph (2) applies where—

(a)a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day; but

(b)the procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 110 (revocation, variation and suspension of certificate of registration) as soon as reasonably practicable.

(3) In making a decision under regulation 110 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 110 in accordance with sub-paragraph (2) in a case where the Co-ordination Group for Mutual Recognition and Decentralised procedures has given an opinion in relation to the matter under Article 31 of the Directive.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11.

(6) Sub-paragraph (7) applies where—

(a)a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day;

(b)the referral has concluded before IP completion day; but

(c)the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(7) The licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the certificate of registration within the time period specified in Article 34(3) of the 2001 Directive where the decision or opinion requires steps to be taken in relation to a certificate of registration.

(8) In this paragraph—

“concluded before IP completion day”, in relation to an Article 31 referral, means—

(a)

a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or

(b)

an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day;

“specified matter” means—

(a)

a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a certificate of registration; but

(b)

does not include a referral made under Article 107i of the 2001 Directive.

PART 9U.K.Transitional provision in respect of traditional herbal registrations

Place of establishment for holders of traditional herbal registrations established in EEA before IP completion dayU.K.

49.—(1) Subject to sub-paragraph (2), any person—

(a)who—

(i)holds a traditional herbal registration immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii)has made an application for, or to renew, a traditional herbal registration before IP completion day, which has not been determined by the licensing authority before that date, or

(iii)makes such an application on or after IP completion day but before the end of the transitional period; and

(b)who was, immediately before IP completion day, established in an EEA State and who remains there on and after that day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 127(3) or 133(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person, only in relation to a registration in force in Great Britain, and only if the person notifies the licensing authority in writing of—

(a)a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the traditional herbal registration, or application for a traditional herbal registration, during the transitional period; and

(b)that individual's address, telephone number and email address.

(3) A person must notify the licensing authority under sub-paragraph (2)—

(a)where sub-paragraph (1)(a)(i) or (ii) applies, within the period of 4 weeks beginning with IP completion day; or

(b)where sub-paragraph (1)(a)(iii) applies, at the time of making the application.

(4) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishmentU.K.

50.—(1) Subject to sub-paragraph (2), a person to whom paragraph 49 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain) during the transitional period in relation to a product to the extent that—

(a)the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

(i)the name and address of the holder of the traditional herbal registration, or, if applicable, the holder's representative,

(ii)the number of the traditional herbal registration, or

(iii)the name and address of the manufacturer of the product; and

(b)the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i)the holder of the traditional herbal registration has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 127(3) or 133(2), and

(ii)the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a)the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b)the holder of the traditional herbal registration, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

List of approved countries for traditional use of a herbal medicinal product on IP completion dayU.K.

51.—(1) For the purpose of regulation 125A (list of approved countries for traditional use of a herbal medicinal product), the licensing authority must, for the transitional period, include each EEA State in the list it publishes under regulation 125A(1).

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 125A(3) to remove an EEA State from the list.

(3) In this paragraph, the transitional period is two years beginning with IP completion day.

Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive appliedU.K.

52.—(1) Sub-paragraph (2) applies where an application for a traditional herbal registration to be in force in Great Britain only has been made before IP completion day and—

(a)regulation 130(12) and (13) (applications to be determined under Chapter 4 of Title III of the 2001 Directive) applied to that application before IP completion day; but

(b)a decision as specified in Article 28(5) of the 2001 Directive has not been adopted by the licensing authority before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must—

(a)where the procedure specified in Article 28(4) of the 2001 Directive has concluded before IP completion day in relation to that application, grant a traditional herbal registration in respect of that application as soon as reasonably practicable, and in any event before the end of the period of 30 days, beginning with IP completion day; or

(b)where the procedure specified in Article 28(4) of the 2001 Directive has not concluded before IP completion day, determine that application in accordance with Part 7 of these Regulations as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they no longer want the application to proceed.

(3) In making a determination under sub-paragraph (2)(b), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the application as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a reference member state or concerned member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) In making a determination under sub-paragraph (2)(b), the licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a traditional herbal registration in the time period specified in regulation 130(1) as if it had applied to that application on the date on which the application was submitted.

Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 DirectiveU.K.

53.  Where, immediately before IP completion day, a traditional herbal registration in force in Great Britain only has been suspended pursuant to the procedures in Chapter IV of Title III of 2001 Directive, the suspension—

(a)continues to have effect on and after IP completion day in accordance with the terms on which it was imposed; and

(b)is to be treated as if it had been imposed by the licensing authority under Part 7 of these Regulations (traditional herbal registrations).

Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion dayU.K.

54.—(1) Sub-paragraph (2) applies where—

(a)a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day; but

(b)the procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 135 (revocation, variation and suspension of traditional herbal registration) as soon as reasonably practicable.

(3) In making a decision under regulation 135 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Chapter 4 of Title III of the 2001 Directive;

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 135 of these Regulations in accordance with sub-paragraph (2) in a case where the Co-ordination Group for Mutual Recognition and Decentralised procedures has given an opinion in relation to the matter under Article 31 of the Directive.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11.

(6) Sub-paragraph (7) applies where—

(a)a specified matter has been referred under Article 31 of the 2001 Directive before IP completion day;

(b)the referral has concluded before IP completion day; but

(c)the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(7) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the traditional herbal registration within the time period specified in Article 34(3) of the 2001 Directive where the decision or opinion requires steps to be taken in relation to a traditional herbal registration.

(8) In this paragraph—

“concluded before IP completion day”, in relation to an Article 31 referral, means—

(a)

a Commission decision as provided for in Article 34(3) of the 2001 Directive has been taken before IP completion day; or

(b)

an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 31 referral procedure, has been given before IP completion day; and

“specified matter” means—

(a)

a matter referred under Article 31 of the 2001 Directive before IP completion day that concerns a proposal to suspend, revoke or otherwise vary a traditional herbal registration; but

(b)

does not include a referral made under Article 107i of the 2001 Directive.

Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion dayU.K.

55.—(1) This paragraph applies where—

(a)the licensing authority has proposed to refer an application for a traditional herbal registration to be in force in Great Britain only to the Committee on Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive before IP completion day; but

(b)that application has not been determined in accordance with Part 7 of these Regulations before IP completion day.

(2) Where the licensing authority has received an opinion of the Committee for Herbal Medicinal Products before IP completion day in relation to the application, it must take that decision in to account and determine that application.

(3) Where the licensing authority has not received an opinion of the Committee for Herbal Medicinal Products before IP completion day, notwithstanding the amendments made to Part 3 of Schedule 11 by the EU Exit Regulations, it may—

(a)proceed to determine the application, taking into account any proceedings that took place before IP completion day under Part 3 of Schedule 11 (prior to its amendment by the EU Exit Regulations), or any opinion of the Committee on Herbal Medicinal Products in relation to the application that is given on or after IP completion day; or

(b)it may refer the matter under regulation 130A in order to obtain the findings and advice of the appropriate committee before determining the application.

PART 10U.K.Transitional provision in respect of pharmacovigilance

Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion dayU.K.

58.—(1) Sub-paragraph (2) applies where—

(a)a specified matter in relation to a UKMA(GB) or a THR(GB) has been referred under Article 107i of the 2001 Directive (urgent Union procedure) before IP completion day; but

(b)that procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 or 135 (revocation, variation and suspension of UKMA(GB) or THR(GB)) as soon as reasonably practicable.

(3) In making a decision under regulation 68 or 135 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for by, or referred to in, Section 4 of Chapter 3 of the 2001 Directive;

(b)any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for by, or referred to in, Section 4 of Chapter 3 of the 2001 Directive; and

(c)any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 or 135 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use or the Co-ordination Group for Mutual Recognition and Decentralised Procedures (as the case may be) has given a final opinion in relation to the matter.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11 (advice and representations).

(6) In making a determination under regulation 68 or 135 in accordance with sub-paragraph (2), the licensing authority may adopt or have regard to any decision made, or agreement reached, in relation to the specified matter under Section 4 of Chapter 3 of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.

(7) Sub-paragraph (8) applies where—

(a)a specified matter in relation to a UKMA(GB) or a THR(GB) has been referred under Article 107i of the 2001 Directive before IP completion day; and

(b)that referral has concluded before IP completion day; but

(c)the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(8) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the UK marketing authorisation or traditional herbal registration—

(a)as soon as reasonably practicable, and, where relevant, within the time period specified in Article 34(3) of the 2001 Directive where a Commission decision requires steps to be taken in relation to a UK marketing authorisation that is not a converted EU marketing authorisation, or traditional herbal registration; or

(b)as soon as reasonably practicable, where a Commission decision or opinion requires steps to be taken in respect of a UK marketing authorisation that is a converted EU marketing authorisation.

(9) In this paragraph—

“concluded before IP completion day”, in relation to an Article 107i referral, means—

(a)

a Commission decision as provided for in Article 107k of the 2001 Directive has been taken before IP completion day; or

(b)

an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 107i referral procedure in accordance with Article 107k(2), has been given before IP completion day;

“specified matter” means a referral made under Article 107i of the 2001 Directive on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities.

Matters on-going at IP completion day in respect of periodic safety update reportsU.K.

59.—(1) Sub-paragraph (2) applies where—

(a)a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

(b)that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive;

(c)the procedure described in Article 107e(3) of the 2001 Directive has been completed before IP completion day; but

(d)the licensing authority has not yet taken the steps described in regulation 194 before IP completion day.

(2) Where this sub-paragraph applies, notwithstanding the amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive) by the EU Exit Regulations, the licensing authority must take the steps specified in regulation 194 in respect of the UKMA(GB) or THR(GB) as soon as reasonably practicable.

(3) Sub-paragraph (4) applies where—

(a)a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

(b)that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive; and

(c)the procedure described in Article 107e(3) of the 2001 Directive has not been completed before IP completion day.

(4) Where this sub-paragraph applies, the licensing authority—

(a)may notify a holder falling within sub-paragraph (3)(a) of the need to provide to it such further information that the licensing authority specifies; and

(b)must, subject to sub-paragraph (5), assess the periodic safety update report in accordance with regulation 195 (obligations on licensing authority to assess PSURs) (as amended by the EU Exit Regulations) as soon as reasonably practicable.

(5) Information required under sub-paragraph (4)(a) must be provided before the end of whatever period the licensing authority may specify.

(6) In making a determination under regulation 195, where sub-paragraph (4) applies, the licensing authority may adopt or have regard to—

(a)any relevant information obtained by it before IP completion day in relation to the periodic safety report and the assessment of that report as a consequence of its involvement in any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

(b)any relevant decision made, or agreement reached, in relation to the periodic safety update report or its assessment before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

(c)any decision made, or agreement reached, in relation to that marketing authorisation or certificate of registration under Section 2 of Chapter III of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.

Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)U.K.

60.—(1) Where the Pharmacovigilance Risk Assessment Committee has, before IP completion day—

(a)issued a letter endorsing a draft study protocol under Article 107n(2)(a) of the 2001 Directive;

(b)informed a holder of a UKMA(GB) or a THR(GB) that the study is a clinical trial under Article 107n(2)(c) of the 2001 Directive; or

(c)informed a holder of its endorsement of a substantial amendment to that protocol under Article 107o of the 2001 Directive,

the licensing authority is deemed to have accepted the draft study protocol, or the amended draft study protocol, or made that decision (as the case may be) under regulation 199(5) (submission of draft study protocols for required studies) or 200(5)(b) (amendment to study protocols for required studies).

(2) Where sub-paragraph (1) applies, the licensing authority may request the holder of a UKMA(GB) or a THR(GB) to provide to it any information in relation to the procedures under Article 107n or 107o of the 2001 Directive within a specified time period, and that holder must provide that information within that time period.

(3) Sub-paragraph (4) applies where, before IP completion day—

(a)a holder of a UKMA(GB) or a THR(GB) is proposing to, or, pursuant to Article 21a or 22a of the 2001 Directive, is under a duty to, undertake a non-interventional post-authorisation safety study; and

(b)the procedure specified in Article 107n or 107o of the 2001 Directive has not concluded before IP completion day.

(4) Where this sub-paragraph applies, on and after IP completion day, the holder must—

(a)submit any further information that has been required of it by the Pharmacovigilance Risk Assessment Committee to the licensing authority; and

(b)submit to the licensing authority such further information that it may request in relation to the procedures under Article 107n or 107o of the 2001 Directive within a time period specified by the licensing authority, whether or not that information has already been submitted to, or received from, that Committee before IP completion day,

and the licensing authority must assess that information in accordance with regulation 199 or 200 (as the case may be).

(5) In this paragraph, “not concluded before IP completion day” means that—

(a)a holder of a UKMA(GB) or a THR(GB) is proposing to, or, pursuant to Article 21a or 22a of the 2001 Directive, is under a duty to, undertake a non-interventional post-authorisation safety study;

(b)the Pharmacovigilance Risk Assessment Committee has not taken any of the steps specified in sub-paragraph (1)(a) to (c).

Matters on-going at IP completion day in respect of the follow up of final study reportsU.K.

61.—(1) Sub-paragraph (2) applies where—

(a)a final study report has been submitted to the Pharmacovigilance Risk Assessment Committee under Article 107p of the 2001 Directive; but

(b)that committee has not, before IP completion day, made recommendations under Article 107q(1) of the 2001 Directive.

(2) Where this sub-paragraph applies—

(a)the licensing authority may, on or after IP completion day, request the holder of a UKMA(GB) or a THR(GB) to submit to it the information specified in regulation 201(2) (submission and evaluation of final study reports for required studies), and such further information relating to the final study report, or the procedure provided for in Chapter 4 of Title IX of the 2001 Directive, as the licensing authority may require; and

(b)that holder of a UKMA(GB) or a THR(GB) must, in any event, undertake the steps specified in regulation 201(5) in respect of that final study report.

(3) Sub-paragraph (4) applies where—

(a)regulation 202(1) (follow-up of final study reports) applied before IP completion day in respect of a final study report; but

(b)the licensing authority has not, before IP completion day, taken the steps specified in regulation 202(2).

(4) Where this paragraph applies, notwithstanding the amendment of regulation 202 by the EU Exit Regulations, the licensing authority must take the steps specified in regulation 202(2) in accordance with the time period specified in that paragraph.

(5) Sub-paragraph (6) applies where—

(a)regulation 202(3) applied before IP completion day; but

(b)the holder of a UKMA(GB) or a THR(GB) has not taken the steps specified in regulation 202(4) before IP completion day.

(6) Where this sub-paragraph applies, notwithstanding the amendment of regulation 202—

(a)the holder of a UKMA(GB) or a THR(GB) must take the steps specified in regulation 202(4); and

(b)the licensing authority must determine that application for a variation in accordance with Part 5 (marketing authorisations) or 7 (traditional herbal registrations).

PART 11U.K.Transitional provision in respect of Part 12

Approved country health professional list on IP completion day (regulation 214(6A))U.K.

62.—(1) For the purposes of regulation 214(6A), for the transitional period, the licensing authority must include on the list published under that paragraph, professions of equivalent professional status to an appropriate practitioner under regulation 214(3) to (5D) in each EEA State.

(2) In this paragraph, “transitional period” is the period of one year beginning with IP completion day.

PART 12U.K.General provision in relation to transitional provisions

Licensing authority power to require informationU.K.

63.—(1) Notwithstanding any other power to require information under this Schedule, the licensing authority may require in writing that a holder of, or an applicant for, a UK marketing authorisation, parallel import licence, manufacturing licence, wholesale dealing licence, certificate of registration or traditional herbal registration provides it with any information which—

(a)is relevant to the exercise of the licensing authority's functions under this Schedule; and

(b)is either in the holder's or applicant's possession or is information which the holder or applicant may reasonably access,

within such time period as the licensing authority specifies in that written request.

(2) If the holder of an authorisation, licence, certificate or registration mentioned in sub-paragraph (1) fails to comply with a request made pursuant to that sub-paragraph, the licensing authority may suspend the authorisation, licence, certificate or registration until the holder complies with the obligation.

(3) Nothing in this Schedule requires a person to supply information in contravention of requirements imposed under the data protection legislation (within the meaning of Part 1 of the Data Protection Act 2018).]

Regulation 348

SCHEDULE 34U.K.Amendments to existing law

PART 1U.K.The Medicines Acts 1968 and 1971

1.  The Medicines Act 1968 is amended as follows.U.K.

2.  For the text of section 1 (Ministers responsible for the administration of Act) substitute—U.K.

In this Act, “the Ministers” has the meaning given by regulation 6(6) to (8) of the 2012 Regulations (but as if references in that regulation to those Regulations were references to this Act).”.

3.  In section 10 M34 (exemptions for pharmacists)—U.K.

(a)in subsection (1) for “a practitioner” substitute “ an appropriate practitioner ”;

(b)in subsections (1) and (4) for “sections 7 and 8 of this Act” substitute “ regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations ”;

(c)in subsection (5) for “section 7 of this Act” substitute “ regulation 46 of the 2012 Regulations ”;

(d)in subsection (6) for “section 8(2) of this Act” substitute “ regulation 17(1) of the 2012 Regulations ”;

(e)omit subsection (7); and

(f)in subsection (8) for the words from “section 92” to the end of the subsection substitute “ regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations ”.

Marginal Citations

M341968, c.67. Section 10(1), 10(3) and 10(7A) were amended and 10(2) repealed by Part 1 paragraphs 1 and 10 of Schedule 8 to S.I. 2006/2407, section 10(1), 10(4) were amended and 10(5) to (7) and 10(8) inserted by article 3 of S.I. 1971/1445, section 10(1) was amended and section 10(9) inserted by paragraph 5 Schedule 1 to the Regulations of Care (Scotland) Act 2001, and section 10(7A) to (7C) were inserted by section 26(1) of the Health Act 2006.

4.  In section 15 (provision for extending or modifying exemptions)—U.K.

(a)omit subsections (1) and (2); and

(b)in subsection (3) M35 for “sections 9 to 14” substitute “ section 10 ”.

Marginal Citations

M35Section 15(3) was amended by paragraphs 1 and 11(b) of Part 1 of Schedule 8 to S.I. 2006/2407.

5.  In section 58 M36 (medicinal products on prescription only)—U.K.

(a)in subsection (1) for the words from the first occurrence of “for the purposes” to the end of the subsection substitute “ as prescription only medicines ”;

(b)omit subsections (1A), (2) and (3);

(c)in the opening words of subsection (4) for “the last preceding subsection” substitute “ regulation 223(1) of the 2012 Regulations ”;

(d)in subsection (4)(a)—

(i)for “paragraph (a) or paragraph (b) of subsection (2) of this section, or both those paragraphs,” substitute “ regulation 214(1) or (2) of the 2012 Regulations ”, and

(ii)for the words from “or, where” to “of this section” substitute “ or, in the case of an appropriate practitioner, other than a doctor or dentist, ”;

(e)in subsection (4)(b) for “paragraph (a) of that subsection” substitute “ regulation 214(1) of the 2012 Regulations ”;

(f)in subsection (4A) for “a person who is an appropriate practitioner by virtue of subsection (1)(d) or (e)” substitute “ an appropriate practitioner, other than a doctor or dentist ”;

(g)in subsection (4C) for “subsection (2)(a) or (b) of this section” substitute “ regulation 214(1) or (2) of the 2012 Regulations ”; and

(h)after subsection (6) insert—

“(7) In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of—

(a)the Commission; or

(b)an expert committee appointed by the Ministers, or by one of them acting alone.”.

Marginal Citations

M36Section 58((1), (4) and (6) was amended by paragraph 29 of Part 1 of Schedule 8 to S.I. 2006/2407. Section 58(4) was amended by paragraph 2(b) of Schedule 5 to S.I. 2002/53. Section 58(4) was amended by section 63(1 and (4) of, and section 58(4A) and (4C) inserted by section 63(1) and (5) of, the Health and Social Care Act 2001.

6.  In section 58A(1) M37 (requirement to specify certain products as prescription-only products)—U.K.

(a)omit paragraphs (a) and (b) and the word “and” following paragraph (b); and

(b)for the words following paragraph (c) to the end of the subsection substitute “is specified as a prescription only medicine”.

Marginal Citations

M37Section 58A was inserted by regulation 2 of S.I. 1992/3271, and the heading substituted by and subsection (1) amended by paragraph 30 Part 1 of Schedule 8 to S.I. 2006/2407.

7.  In section 62 M38 (prohibition of sale or supply, or importation, of medicinal products of specified description), after subsection (7) add—U.K.

“(8) In this section “the appropriate committee” means whichever the Ministers consider appropriate of—

(a)the Commission; or

(b)an expert committee appointed by the Ministers, or by one of them acting alone.”.

Marginal Citations

M38Section 62(7) was substituted by paragraph 12(5) of Schedule 1 to S.I. 2005/1094.

8.  In section 64(5) (protection for purchasers of medicinal products) for “a practitioner” substitute “ an appropriate practitioner ”.U.K.

9.—(1) Section 67 M39 (offences under Part III) is amended as follows.U.K.

(2) In subsection (1B)(a) for “by virtue of provision made under section 58(1) of this Act” substitute “ within the meaning of regulation 214 of the 2012 Regulations ”;

(3) in subsection (2)—

(a)for “52, 58, 63, 64 and 65”, substitute “ 63 and 64 ”; and

(b)omit “any regulations made under section 60 or section 61 or”.

(4) Omit subsection (3A).

(5) In subsection (4) for “subsection (1A), (1B), (2), (3) or (3A)” substitute “ subsection (1A), (1B), (2) or (3) ”.

(6) Omit subsections (5) and (6).

Marginal Citations

M39Section 67(1B) was inserted by section 63(7) of the Health and Social Care Act 2001, and section 67(3A) inserted and section 67(4) amended by paragraph 8 of Schedule 5 to S.I. 2005/2789

10.  In section 72 (representative of pharmacist in case of death or disability)—U.K.

(a)in paragraph (1)(c) M40, for the words from “a committee” to the end of paragraph (c) substitute “a controller is appointed in his case under the Mental Health (Northern Ireland) Order 1986 M41 ”; and

(b)in paragraph (4)(c) for “committee” substitute “ controller ”.

Marginal Citations

M40Section 72(1)(c) was amended by paragraph 12(a) of Schedule 5 to the Adults with Incapacity (Scotland) Act 2000 and paragraph 14(a) of Schedule 6 to the Mental Capacity Act 2005, and section 72(4)(c) by paragraph 14(d) of Schedule 6 to the Mental Capacity Act 2005.

11.  In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical Society” substitute—U.K.

(a)in the first place it appears, “General Pharmaceutical Council or, in Northern Ireland, the Pharmaceutical Society of Northern Ireland”; and

(b)in the second place it appears, “Council or the Society”.

12.  In section 87 M42 (requirements as to containers)—U.K.

(a)in subsection (1) for “section 85(2) of this Act” substitute “ subsection (3) ”; and

(b)after subsection (2) insert—

“(3) The purposes mentioned in subsection (1) are—

(a)securing that medicinal products are correctly described and readily identifiable;

(b)securing that any appropriate warning or other appropriate instruction or information is given, and that false or misleading information is not given, with respect to medicinal products;

(c)promoting safety in relation to medicinal products.”

Marginal Citations

M42Section 87(1) was amended by paragraph 44 of Part 1 of Schedule 8 to S.I. 2006/2407.

13.  In section 88(1) M43 (distinctive colours, shapes and markings of medicinal products) for “section 85(2)” substitute “ section 87(3) ”.U.K.

Marginal Citations

M43Section 88(1) was amended by paragraph 45 of Part 1 of Schedule 8 to S.I. 2006/2407.

14.  In section 91 M44 (offences under Part V, and supplementary provisions)—U.K.

(a)omit subsection (1);

(b)in subsection (2) omit “section 85(3), section 86(2) or”; and

(c)in subsection (3) for “sections 85 to” substitute “ section ”.

Marginal Citations

M44Section 91(2) and (3) was amended by paragraph 48(b) and (c) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 91(2) was amended by section 32(2) of the Magistrates' Courts Act 1980.

15.  In section 104 (application of Act to certain articles and substances)—U.K.

(a)in the heading to the section for “Act” substitute “ the 2012 Regulations ”; and

(b)in paragraph (1) for “this Act” substitute “ the 2012 Regulations ”.

16.  In section 105 (application of Act to certain other substances which are not medicinal products)—U.K.

(a)in the heading to the section for “Act” substitute “ the 2012 Regulations ”; and

(b)in paragraph (1) for “this Act” substitute “ the 2012 Regulations ”.

17.  In section 107 (validity of decisions and proceedings relating thereto)—U.K.

(a)in subsection (1)—

(i)omit “of the licensing authority under Part II of this Act or”, and

(ii)for “licence or certificate granted or issued” substitute “ certificate issued ”;

(b)in subsection (4)—

(i)for “grant a licence or certificate” substitute “ issue a certificate ”,

(ii)for “licence or certificate granted” substitute “ certificate issued ”, and

(iii)for “grant of the licence or” substitute “ issue of the ”;

(c)in subsection (6) omit “of Justice”.

18.—(1) Section 108 M45 (enforcement in England and Wales) is amended as follows.U.K.

(2) In subsection (2)—

(a)in paragraph (a) for the words from “sections 64” to “and 89(2)” substitute “ section 64 and sections 87(2) and 88(3) ”;

(b)omit paragraphs (b) and (c); and

(c)in the words following those paragraphs—

(i)for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”,

(ii)for “the Society” substitute “ the Council ”,

(iii)for “that Society” substitute “ that Council ”

(iv)for “paragraphs (a) and (b)” substitute “ paragraph (a) ”,

(v)for “those paragraphs” substitute “ that paragraph ”, and

(vi)omit the words from “, and the provisions” to the end of the subsection.

(3) Omit subsections (3) to (5).

(4) In subsection (6)—

(a)for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”;

(b)omit paragraph (a); and

(c)in paragraph (b) omit “or section 61”.

(5) In subsections (6A) and (6B) for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”.

(6) Omit subsection (7).

(7) In subsection (9) for “(7)” substitute “ (6D) ”.

(8) In subsection (10)—

(i)for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”, and

(ii)for the words from “or any” to “that duty” substitute “ has in relation to any matter failed to perform a duty imposed on it by subsections (6A) or (6B) to enforce any provisions mentioned in those subsections ”.

(9) In subsection (12) for paragraphs (a) and (b) substitute—

“(a)in relation to an area in England other than the City of London, the council of a non-metropolitan county, metropolitan district or London borough;

(b)in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London; and

(c)in relation to an area in Wales, the council of a county or county borough.”.

Marginal Citations

M45Section 108(2) was amended and 108(12) inserted by paragraph 8 of Schedule 3 to the Food Safety Act 1990, section 108(6A) to (6D) was inserted and section 108(9) and (10) amended by section 31(1) of the Health Act 2006, section 108(9) was amended by paragraph 56(c), section 108(10) by paragraph 56(d) and section 108(11) by paragraph 56(e) of Part 1 of Schedule 8 to S.I. 2006/2407, and section . 108(12) was amended by paragraph 33 of Schedule 16 to the Local Government (Wales) Act 1994.

19.  In section 109 M46 (enforcement in Scotland)—U.K.

(a)in subsection (2)—

(i)for the words from “(2)” to “(10)” substitute “ (2), (6) to (6D), (9) and (10) ”, and

(ii)in paragraph (a) omit the words from “or” to “jointly”; and

(b)omit subsection (3).

Marginal Citations

M46Section 109(2)(c) was repealed by paragraph 9(a) of Schedule 3 to the Food Safety Act 1990, and section 109(2)(d) was repealed by paragraph 57 of Part 1 of Schedule 8 to S.I. 2006/2407.

20.  In section 110 M47 (enforcement in Northern Ireland)—U.K.

(a)in subsection (1), for “Minister of Health and Social Services for Northern Ireland” substitute “ Minister for Health, Social Services and Public Safety ”;

(b)in subsection (2)—

(i)for “paragraphs (a) and (b)” substitute “ paragraph (a) ” in both places where it occurs,

(ii)for the words from “those paragraphs” to “subsection” substitute “ that paragraph ”,

(iii)for “area” substitute “ district ”M48 ,

(iv)for “health authority” in both places where it occurs substitute “ district council ”,

(v)omit the words “and the provisions and regulations specified in the said paragraph (c)”;

(c)omit subsection (3);

(d)in subsections (3A) and (3B), after “the Pharmaceutical Society” insert “ of Northern Ireland ”;

(e)in subsection (5)—

(i)for “Subsections (9) and (10)” substitute “ Subsection (9) ”,

(ii)in paragraph (a) for “(2) to (7)” substitute “ (2) to (6D) ”, and

(iii)omit paragraph (b) and the word “and” preceding that paragraph;

(f)omit subsections (6) and (7); and

(g)for subsection (8) substitute—

“(8) In this section “district council” means a council established under the Local Government Act (Northern Ireland) 1972 M49.”.

Marginal Citations

M47Section 110(1) was amended by paragraph 58(a) and section 110(5)(a) was amended by paragraph 58(c)(i) of Part 1 of Schedule 8 to S.I. 2006/2407, and section 110(3A) and (3B) were inserted by section 31(3)(b) and section 110(5)(a) amended by section 31(3)(c) of the Health Act 2006. In relation to Northern Ireland,

M48The amendments in paragraph 19(b)(iii) and (iv), (f) and (g) reproduce amendments already made with effect in Northern Ireland by article 2 and the Schedule to S.R. (NI) 1973 No 211.

21.  In section 111 M50 (rights of entry)—U.K.

(a)in subsection (1) omit paragraph (aa) except for the word “or”;

(b)in subsection (2) omit paragraph (a);

(c)omit subsection (3);

(d)in subsection (6) omit—

(i)“aircraft,” in both places where it occurs, and

(ii)“, commander”; and

(e)for subsection (9) substitute—

“(9) References in this section to a justice of the peace—

(a)in relation to England, include a reference to a district judge (magistrates' courts);

(b)in relation to Scotland, are to be read as references to a sheriff, stipendiary magistrate or justice of the peace, and

(c)in relation to Northern Ireland, are to be read as references to a lay magistrate or a district judge (magistrates' courts).”.

Marginal Citations

M50Section 111(1)(aa) was inserted by paragraph 9 of Schedule 5 to S.I. 2005/2789.

22.  In section 113(1) (application of sampling procedure to substance or article seized under section 112), omit the words from “(including” to the end of the subsection.U.K.

23.  In section 114(1) (supplementary provisions as to rights of entry and related rights), omit—U.K.

(a)“aircraft,” in both places where it occurs; and

(b)“, commander”.

24.  In section 121(4) M51 (contravention due to default of other person), for the words from “63” to “96” substitute “ 63, 64, 87 and 88 ”.U.K.

Marginal Citations

M51Section 121(4) was amended by paragraph 61 of Part 1 of Schedule 8 to S.I. 2006/2407.

25.  In section 122(2) M52 (warranty as defence), for the words “section 63(b), sections 64 and 65, sections 85 to 88” substitute “ sections 63(b), 64, 87 and 88 ”.U.K.

Marginal Citations

M52Section 122(2) was amended by paragraph 62 of Part 1 of Schedule 8 to S.I. 2006/2407.

26.  In section 123(1)(b) (offences in relation to warranties and certificates of analysis), omit “section 115 of this Act, or under”.U.K.

27.  In section 125 M53 (prosecutions)—U.K.

(a)in subsection (4)—

(i)for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council ”, and

(ii)for “that Society” substitute “ the Council ”;

(b)in subsections (6) and (7) for “Minister of Health and Social Services for Northern Ireland” substitute “ Minister for Health, Social Services and Public Safety ”.

Marginal Citations

M53Section 125(4) was amended by paragraph 63 of Part 1 of Schedule 8 to S.I. 2006/2407.

28.  In section 126 M54 (presumptions)—U.K.

(a)in subsection (1), omit paragraph (b) and the word “or” following it;

(b)in subsection (3), omit “subsections (3) and (5) of section 85,”; and

(c)omit subsection (4).

Marginal Citations

M54Section 126(3) was amended by paragraph 64(c) of Part 1 of Schedule 8 to S.I. 2006/2407.

29.  In section 128 (financial provisions)—U.K.

(a)in subsection (1), for the words from “any of” to “section 1(1) of this Act” substitute “ either of the Ministers ”;

(b)in subsections (4) and (5), for “the Pharmaceutical Society” substitute “ the General Pharmaceutical Council or (as the case may be) the Pharmaceutical Society of Northern Ireland ”;

(c)in subsection (5), for “a Minister” substitute “ either of the Ministers ”; and

(d)in subsection (6), for the words from “any of the Ministers” to “Ireland” substitute “ the Secretary of State ”.

30.  In section 129 M55 (orders and regulations)—U.K.

(a)in subsection (2), omit the words from “or any regulations” to “section 120 of this Act”;

(b)in subsection (3)—

(i)in paragraph (a), for the words from “13” to “and 130(5)(c)” substitute “ 58, 62, 79 and 106 ”, and

(ii)omit paragraph (b);

(c)in subsection (4) omit the words from “, other” to “69(3),”, and

(d)in subsection (7)—

(i)omit “Part V or Part VI”, and

(ii)for the words “a committee established under section 4 of this Act” substitute “ an expert committee appointed by themselves, or by one of them acting alone ”.

Marginal Citations

M55Section 129(2) was amended by paragraph 65(a) of and section 129(3) was amended by paragraph 65(b) of Part 1 of Schedule 8 to S.I. 2006/2407.

31.  In section 130 M56 (meaning of medicinal product and related expressions)—U.K.

(a)for subsection (1) substitute—

“(1) In this Act, “medicinal product” has the meaning given by regulation 2 of the 2012 Regulations.”; and

(b)omit subsections (2) to (8) and (10).

Marginal Citations

M56Section 130(1) was amended by paragraph 66(a) of Part 1 of Schedule 8 to S.I. 2006/2407.

32.  In section 131(5) M57 (meaning of “wholesale dealing”, “retail sale” and related expressions) for “or the Health and Personal Social Services (Northern Ireland) Order1972” substitute “ , the Health and Personal Social Services (Northern Ireland) Order 1972 or the Health and Social Care (Reform) Act (Northern Ireland) 2009 ”.U.K.

Marginal Citations

M57Section 131(5) was amended by paragraphs 43 and 44 of Schedule 1 to the National Health Service (Consequential Provisions) Act 2006, paragraph 30 of Schedule 16 to the National Health Service (Scotland) Act 1978 and paragraph 128(2) of Schedule 4 to the National Health Service Reorganisation Act 1973.

33.  In section 132 (general interpretation provisions)—U.K.

(a)for subsection (1) substitute—

“(1) In this Act—

(a)unless the context otherwise requires, any expression defined by any provision of the 2012 Regulations, and not defined in this Act, has the same meaning as it has for the purposes of those Regulations; and

(b)“the 2012 Regulations” means the Human Medicines Regulations 2012.”;

(b)omit subsections (2) and (3);

(c)in subsection (4) omit “licence or” in each place it appears; and

(d)omit subsection (5).

34.  In Schedule 3 M58 (sampling)—U.K.

(a)omit paragraphs 5 to 7;

(b)in paragraph 8 for “3 to 7” substitute “ 3 or 4 ”;

(c)in paragraph 9 for “3 to 8” substitute “ 3, 4, or 8 ”; and

(d)in paragraph 17, in the words following paragraph (c)—

(i)for the words “a health authority” substitute “ the Pharmaceutical Society of Northern Ireland ”, and

(ii)for “the Minister of Health and Social Services for Northern Ireland” substitute “ the Minister for Health, Social Services and Public Safety ”.

Marginal Citations

M58Paragraph 17 of Schedule 3 was amended by paragraph 66 of Part 1 of Schedule 8 to S.I. 2006/2407.

35.  In Schedule 4 M59 (provisions relating to Northern Ireland)—U.K.

(a)for every reference to “the Minister of Health and Social Services for Northern Ireland” substitute “ the Minister for Health, Social Services and Public Safety ”;

(b)in paragraph 6 omit the words from “(except” to “Act)”;

(c)in paragraph 8 omit the words from “, and every regulation made solely” to “this Act,”; and

(d)in paragraph 10 for “the Ministry of Health and Social Services for Northern Ireland” substitute “ the Department of Health, Social Services and Public Safety ”.

Marginal Citations

M59Paragraphs 2 to 5, 7 and 9(b) and (c) and following words of Schedule 4 were omitted by paragraphs 69(a), (c) and (e)(iii) and (iv) of Part 1 of Schedule 8 to S.I. 2006/2407. Paragraph 6 was amended by paragraph 69(b), paragraph 8 by paragraph 69(d), paragraph 9 by paragraph 69(e) and paragraph 10 by paragraph 69(f) of that Part.

Medicines Act 1971U.K.

36.—(1) The Medicines Act 1971 M60 shall have effect as follows.U.K.

(2) In section 1 (fees)—

(a)in subsection (1), the reference to any application in pursuance of the Medicines Act 1968 for a licence or certificate under Part II of that Act, or for the variation or renewal of such a licence or certificate, shall have effect as a reference to any application under Parts 3 to 8 of these Regulations for the grant, variation or renewal of—

(i)a manufacturer's licence,

(ii)a wholesale dealer's licence,

(iii)a marketing authorisation,

(iv)a certificate of registration,

(v)a traditional herbal registration, or

(vi)an Article 126a authorisation; and

(b)in subsection (2)(b), the reference to any licence or certificate under the Medicines Act 1968 shall have effect as a reference to a manufacturer's licence, a wholesale dealer's licence, a marketing authorisation, a certificate of registration, a traditional herbal registration, or an Article 126a authorisation under these Regulations.

(3) Paragraph (2) has effect in relation to references of the kind mentioned in that paragraph in regulations made under section 1.

Marginal Citations

PART 2U.K.Other primary legislation

Trade Descriptions Act 1968U.K.

37.  In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act 1968 M61 for the words from “made under Part V” to “that Act)” substitute “ of Chapter 1 of Part 13 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M611968 c.29. Paragraph (b) of section 2(5) was inserted by paragraph 16 of Schedule 5 to the Medicines Act 1968.

House of Commons Disqualification Act 1975U.K.

38.  In Part II (bodies of which all members are disqualified) of Schedule 1 to the House of Commons Disqualification Act 1975 M62 for the entry for the Commission for Human Medicines and any committee established under section 4 of the Medicines Act 1968 substitute—U.K.

“The Commission on Human Medicines.”.

Marginal Citations

Northern Ireland Assembly Disqualification Act 1975U.K.

39.  In Part II (bodies of which all members are disqualified) of Schedule 1 to the Northern Ireland Assembly Disqualification Act 1975 M63 for the entry for the Commission for Human Medicines and any committee established under section 4 of the Medicines Act 1968 substitute—U.K.

“The Commission on Human Medicines.”.

Marginal Citations

Consumer Protection Act 1987U.K.

40.  Section 19(1) (interpretation of Part II) of the Consumer Protection Act 1987 M64 shall have effect as if, in the definition “licensed medicinal product”, the reference to any medicinal product within the meaning of the Medicines Act 1968, in respect of which a product licence within the meaning of that Act is for the time being in force, included a reference to a medicinal product, in respect of which a marketing authorisation or a traditional herbal registration within the meaning of these Regulations is for the time being in force.U.K.

Marginal Citations

M641987 c.43. Section 19(1) was amended by paragraph 7 of Part 1 of Schedule 9 to S.I. 2006/2407; there are other amendments to that subsection, but none is relevant.

Environmental Protection Act 1990U.K.

41.  In section 142(7) (powers to obtain information about potentially hazardous substances) of the Environmental Protection Act 1990 M65, for the entry relating to the Medicines Act 1968 substitute “ Parts 3 to 8 and 16 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M651990 c.43. Section 142(7) was amended by paragraph 8 of Schedule 4 to the Radioactive Substances Act 1993 (1993 c.12), in relation to England and Wales by paragraph 5(1) and (12) of Part 1 of Schedule 26 to S.I. 2010/675, and by paragraph 8 of Part 1 of Schedule 9 to S.I. 2006/2407.

Value Added Tax Act 1994U.K.

42.  In Part II of Schedule 8 (zero-rating) to the Value Added Tax Act 1994 M66—U.K.

(a)in note (2B) to Group 12 (drugs, medicines, aids for the handicapped etc) for the words “article 1(2) of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”; and

(b)in note (11) to Group 15 (charities etc)—

(i)for paragraph (a) substitute—

“(a)“medicinal product” has the meaning assigned to it by regulation 2(1) of the Human Medicines Regulations 2012;”, and

(ii)omit paragraphs (b) and (c).

Marginal Citations

M661994 c.23. In Part II of Schedule 8, note (2B) to Group 12 was inserted by S.I. 2009/2972, and note (11)(a) to Group 15 was amended by paragraph 10(a), and (11)(d) inserted by paragraph 10(b), of Schedule 9 to S.I. 2006/2407.

Health Act 1999U.K.

43.  In section 60(2A)(c) (regulation of health care and associated professions) of the Health Act 1999 M67, after “that Act” insert “ or the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M671999 c.8. Subsection (2A) was inserted by paragraph 1 of Schedule 8 to the Health and Social Care Act 2008 (2008 c.14).

Communications Act 2003U.K.

44.  In section 368R(1) (interpretation of Part 4A) of the Communications Act 2003 M68, for the definition “prescription-only medicine” substitute the following definition—U.K.

““prescription-only medicine” means a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations 2012;”.

Marginal Citations

M682003 c.21. Section 368R was inserted by regulation 2 of S.I. 2009/2979.

Christmas Day and New Year's Day Trading (Scotland) Act 2007U.K.

45.  In section 7 (interpretation) of the Christmas Day and New Year's Day Trading (Scotland) Act 2007 M69—U.K.

(a)omit the definition “appropriate person”; and

(b)for the definition “on prescription” substitute the following definition—

““on prescription” means in accordance with a prescription given by an appropriate practitioner, within the meaning of regulation 214(1) and (3) to (6) (sale or supply of prescription only medicines) of the Human Medicines Regulations 2012;”.

Marginal Citations

PART 3U.K.Northern Ireland Orders in Council

Health and Personal Social Services (Northern Ireland) Order 1972U.K.

46.  The Health and Personal Social Services (Northern Ireland) Order 1972 M70 is amended as follows—U.K.

(a)in article 2(2), in the definition “pharmacist” for “Medicines Act 1968” substitute “ Human Medicines Regulations 2012 ”; and

(b)in article 57D—

(i)in paragraphs (3) and (5) for “Community” substitute “ EU ”, and

(ii)in paragraph (5) for “regulation 1 of the Medicines for Human Use (Marketing Authorisations etc Regulations 1997” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Marginal Citations

Pharmacy (Northern Ireland) Order 1976U.K.

47.  In article 2(2) of the Pharmacy (Northern Ireland) Order 1976 M71, in the definition “retail pharmacy business” for “section 132(1) of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

Poisons (Northern Ireland) Order 1976U.K.

48.  In article 2(2) of the Pharmacy (Northern Ireland) Order 1976 M72—U.K.

(a)in the definition “pharmacist” after “Medicines Act” insert “ or the Human Medicines Regulations 2012 ”; and

(b)in the definition “retail pharmacy business” for “section 132(1) of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Marginal Citations

Diseases of Animals (Northern Ireland) Order 1981U.K.

49.  In article 38 of the Diseases of Animals (Northern Ireland) Order 1981 M73 in the definition “retail pharmacy business” for “section 132(1) of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

Waste and Contaminated Land (Northern Ireland) Order 1997U.K.

50.  In article 33(6) of the Waste and Contaminated Land (Northern Ireland) Order 1997 M74 for the entry relating to the Medicines Act 1968 substitute “ Parts 3 to 8, 12 and 16 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M74S.I. 1997/2778 (N.I. 19). Article 33(6) was amended by S.R. (NI) 2006 No 45.

Shops (Sunday Trading &c.) (Northern Ireland) Order 1997U.K.

51.  In article 4(3) of the Shops (Sunday Trading &c.) (Northern Ireland) Order 1997 M75 for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

PART 4U.K.The Medicines for Human Use (Clinical Trials) Regulations 2004

52.  The Medicines for Human Use (Clinical Trials) Regulations 2004 M76 are amended as follows.U.K.

Marginal Citations

M76S.I. 2004/1031, as amended by S.I. 2005/2754. There are other amendments, but none is relevant.

53.  In regulation 2(1) (interpretation)—U.K.

(a)before the definition “the Act” insert the following definition—

““the 2012 Regulations” means the Human Medicines Regulations 2012;”;

(b)for the definition “appropriate committee” substitute—

““appropriate committee” for the purposes of any provision of these Regulations under which a function falls to be performed means whichever the licensing authority considers to be appropriate of—

(a)

the Commission on Human Medicines; or

(b)

an expert committee appointed by the licensing authority;”;

(c)insert in the appropriate position in alphabetical order the following definition—

““the Commission on Human Medicines” means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;”;

(d)in the definition “licensing authority” for “section 6 of the Act” substitute “ regulation 6 of the 2012 Regulations ”;

(e)for sub-paragraph (a) of the definition “marketing authorisation” substitute—

“(a)a UK marketing authorisation granted by the licensing authority under the 2012 Regulations,”; and

(f)for the definition “medicinal product” substitute—

““medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.”

54.  In regulation 4(3) (responsibility for functions under the Directive) for “the Act” substitute “ the 2012 Regulations ”.U.K.

55.  In regulation 19(10) (authorisation procedure for clinical trials involving medicinal products for gene therapy etc) omit “established by section 2A of the Act”.U.K.

56.  In regulation 46(2)(c) (labelling) for words from “Schedule 5” to the end of the sub-paragraph substitute “ Part 13 of the 2012 Regulations that apply in relation to medicinal products sold or supplied in accordance with a prescription given by a person who is an appropriate practitioner within the meaning of regulation 214(3) to (6) of those Regulations ”.U.K.

57.  In regulation 47 (application of enforcement provisions of the Act)—U.K.

(a)for “the Act” in the heading substitute “ the 2012 Regulations ”; and

(b)for paragraph (1) substitute—

“(1) Regulations 2, 8(1), 322, 323(1), 324(1), 325 to 330, 332 to 339, 343 and Schedule 31 of the 2012 Regulations (“those provisions”) shall apply for the purposes of these Regulations as they apply for the purposes of the 2012 Regulations, but with the modifications specified in Schedule 9, and any reference in those provisions to the 2012 Regulations includes a reference to these Regulations.”; and

(c)after paragraph (2) insert the following paragraph—

“(3) In those provisions as applying by virtue of paragraph (1), any reference to, or relating to, a requirement, a power, a function, a right, a duty, an entitlement, or a protection shall be read as a reference to, or relating to, that requirement, power, function, right, duty, entitlement, or protection as applied by this regulation.”.

58.  In regulation 48(5) (infringement notices) for “sections 108 to 110 of the Act” substitute “ regulation 323(1) or 324(1) of the 2012 Regulations ”.U.K.

59.  In regulation 49(5) (offences) for “the Act” substitute “ the 2012 Regulations ”.U.K.

60.  In regulation 53(3) (construction of references to specified publications) for “section 103(1) of the Act” substitute “ regulation 321(1) of the 2012 Regulations ”.U.K.

61.  In paragraph 4(2) of Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials)—U.K.

(a)in sub-paragraph (a), for paragraphs (i) to (iii) substitute—

“(i)the Commission on Human Medicines,

(ii)an expert committee appointed by the licensing authority,

(iii)an expert advisory group within the meaning of regulation 14 of the 2012 Regulations,

(iv)the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees,

(v)the Medicines Commission formerly established under section 2 of the Act, or any of its committees,

(vi)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or

(vii)the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and”; and

(b)in sub-paragraph (b) after “Crown” insert “ , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister ”.

62.  In Schedule 7 (standard provisions for manufacturing authorisations)—U.K.

(a)in Part 2—

(i)in paragraph 5 for “the Act” substitute “ the 2012 Regulations ”,

(ii)in paragraph 9 for “the Act or any regulations under the Act” substitute “ or the 2012 Regulations ”, and

(iii)in paragraph 13—

(aa)for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb)for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”; and

(b)in Part 3—

(i)in paragraph 6 for “the Act” in the first place where it occurs substitute “ the 2012 Regulations ”, and

(ii)in paragraph 8—

(aa)for “Part II of the Act” substitute “ Parts 3 to 8 of the 2012 Regulations ”, and

(bb)for “the Act” in the second place where it occurs substitute “ the 2012 Regulations ”.

63.  In paragraph 5(2) of Schedule 8 (procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations)—U.K.

(a)in sub-paragraph (a), for paragraphs (i) to (iii) substitute—

“(i)the Commission on Human Medicines,

(ii)an expert committee appointed by the licensing authority,

(iii)an expert advisory group within the meaning of regulation 14 of the 2012 Regulations,

(iv)the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees,

(v)the Medicines Commission formerly established under section 2 of the Act, or any of its committees,

(vi)the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or

(vii)the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and”; and

(b)in sub-paragraph (b) after “Crown” insert “ , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister ”.

64.  For Schedule 9 substitute the following Schedule—U.K.

Regulation 47(1)

“SCHEDULE 9U.K.MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE 2012 REGULATIONS SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

1.  The modifications of the 2012 Regulations mentioned in regulation 47 are as follows.

2.  In regulation 2 (medicinal products)—

(a)at the beginning of paragraph (1) insert “ Subject to paragraph (3), ”; and

(b)after paragraph (2) insert the following paragraph—

“(3) “Medicinal product” includes any investigational medicinal product.”.

2.  In regulation 8(1) (interpretation)—

(a)the definition “assemble” is substituted by the definition of that expression in regulation 2(1) of these Regulations; and

(b)there is inserted in the appropriate position in alphabetical order a definition “container” in the same terms as the definition of that expression in regulation 2(1) of these Regulations; and

(c)the definition “qualified person” is substituted by the definition of that expression in regulation 2(1) of these Regulations.

3.  In regulation 322(1) (validity of decisions and proceedings) omit “or” and insert a comma before “ 8 (Article 126a authorisations) ”, and after those words insert “ or the Clinical Trials Regulations ”.

4.  In regulation 325(1) (rights of entry) insert after sub-paragraph (b) the following sub-paragraph—

“(ba)in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations;”.

5.—(1) Regulation 327 (powers of inspection, sampling and seizure) is amended as follows.

(2) In paragraph (1)—

(a)after sub-paragraph (b) omit “; or”;

(b)after sub-paragraph (c) insert “ ; or ” and the following sub-paragraph—

“(d)in order to verify any statement contained in an application or request for an authorisation under the Clinical Trials Regulations.”.

(3) After paragraph (2)(g) insert the following sub-paragraph—

“(h)information and documents relating to clinical trials”.

(4) In paragraph (3)—

(a)omit “or” following sub-paragraph (a); and

(b)following paragraph (b) insert “ ; or ” and the following sub-paragraph—

“(c)a medicinal product used, or intended to be used, in a clinical trial”.

(5) In paragraph (4)—

(a)after “require” insert “ — (a) ”; and

(b)after “control” insert “ ; or ” and the following sub-paragraph—

“(b)a person associated with a clinical trial to produce information or documents relating to the clinical trial which are in the person's possession or under the person's control”.

(6) In paragraph (5)(a) for “(2)(f) or (g)” substitute “ (2)(f), (g) or (h) ”.

(7) After paragraph (9) insert the following paragraph—

“(10) In this regulation, “a person associated with a clinical trial means any of the following—

(a)the sponsor of a clinical trial (within the meaning of regulation 3 of the Clinical Trials Regulations);

(b)any person who, under arrangements made with the sponsor of a clinical trial, carries out functions of the sponsor of the trial;

(c)in investigator for a clinical trial (within the meaning of regulation 2(1) of the Clinical Trials Regulations);

(d)any person, other than an investigator, who conducts a clinical trial;

(e)any person occupying premises at which a clinical trial is being conducted; or

(f)any person who, in the course of employment with a person listed in any of sub-paragraphs (a) to (e), undertakes activities in connection with a clinical trial.”.

(8) In regulation 335(6) (contravention due to fault of another person) omit “and” after sub-paragraph (e) and after sub-paragraph (f) insert “ ; and ” and the following sub-paragraph—

“(g)any obligation or prohibition under the Clinical Trials Regulations”.

(9) In regulation 336(3) (warranty as defence) omit “and” after sub-paragraph (c) and after sub-paragraph (d) insert “ ; and ” and the following sub-paragraph—

“(e)regulation 46 of the Clinical Trials Regulations (labelling)”.”

PART 5U.K.Other United Kingdom, Scotland and Wales Secondary legislation

Medicines (Administration of Radioactive Substances) Regulations 1978U.K.

65.  In regulation 8(1) of the Medicines (Administration of Radioactive Substances) Regulations 1978 M77—U.K.

(a)for “Section 6(2) of the Act” substitute “Regulation 6(3) of the Human Medicines Regulations 2012 (“the 2012 Regulations”); and

(b)for “by or under the Act” substitute “ by the 2012 Regulations ”.

Marginal Citations

M77S.I. 1978/1006, as amended by S.I. 1995/2147 and S.I. 2006/2407. There are other amendments, but none is relevant.

Importation of Animal Products and Poultry Products Order 1980U.K.

66.  In the Schedule to the Importation of Animal Products and Poultry Products Order 1980 M78, for “or the Medicines for Human Use (Marketing Authorisations Etc. Regulations) 1994” substitute “ or the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986U.K.

67.  In rule 2 of The Medicines Act (Hearings by Persons Appointed) Rules 1986 M79—U.K.

(a)in the definition “applicant” omit the words “a licence or certificate under Part II or a direction under section 47(6) (application for a direction concerning incorporation of standard conditions into a licence or certificate) or”;

(b)in the definition “person appointed” omit—

(i)sub-paragraphs (i), (ii), (iii), (v) and (vi), and

(ii)the words following sub-paragraph (vii), from “including” until the end of the definition; and

(c)in the definition “relevant Minister”—

(i)omit sub-paragraph (i), and

(ii)in sub-paragraph (ii) for “the appropriate Ministers as defined in section 1(2)” substitute “ the Ministers as defined in regulation 6(6) and (7) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012 ”.

Marginal Citations

M79S.I. 1986/1700. There are amendments, but none is relevant.

Medicines Act (Hearings by Persons Appointed) Rules 1986U.K.

68.  In rule 2 of The Medicines Act (Hearings by Persons Appointed) Rules 1986 M80—U.K.

(a)in the definition “applicant” omit the words “a licence or certificate under Part II or a direction under section 47(6) (application for a direction concerning incorporation of standard conditions into a licence or certificate) or”;

(b)in the definition “person appointed” omit—

(i)sub-paragraphs (i), (ii), (iii), (v) and (vi), and

(ii)the words following sub-paragraph (vii), from “including” until the end of the definition; and

(c)in the definition “relevant Minister”—

(i)omit sub-paragraph (i), and

(ii)in sub-paragraph (ii) for “section 1(1)” substitute “ regulation 6(6) and (7) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012 ”.

Marginal Citations

M80S.I. 1986/1761, as amended by S.I. 2006/2407. There are other amendments, but none is relevant.

Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989U.K.

69.—(1) The Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 M81 is amended as follows.U.K.

(2) In article 1(2) insert after the definition “ the 1987 Act ” the following definition—

““the 2012 Regulations” means the Human Medicines Regulations 2012;”.

(3) In Schedule 1—

(a)in paragraph 1 omit “, II” and “, VI”;

(b)after paragraph 1 insert the following paragraph—

“1A.  Functions of the Ministers under the 2012 Regulations (except those under Part 15 (British Pharmacopeia) of those Regulations), subject to paragraph 11 below.”.

(c)in paragraph 2 for “Part II of the 1968 Act “ substitute “Parts 3 to 8 of the 2012 Regulations”;

(d)for paragraph 3 substitute—

“3.  Functions of the Commission on Human Medicines, whose continuation is provided for in regulation 9 of the 2012 Regulations (except those under Part 15 (British Pharmacopoeia) of those Regulations).”;

(e)for paragraph 4 substitute—

“4.  Functions of any expert committee appointed by the licensing authority under the 2012 Regulations.”.

(f)for paragraph 8 substitute—

“8.  Functions of reviewers appointed under the 2012 Regulations.”.

(g)omit paragraphs 9A, 9C and 9D;

(h)in paragraph 10(c) for “and of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ and of the 2012 Regulations ” and

(i)in paragraph 11—

(i)after “Paragraphs 1” insert “ , 1A ”, and

(ii)after “under it” insert “ or under the 2012 Regulations ”.

Marginal Citations

M81S.I. 1989/684, as amended by S.I. 1995/871, S.I. 2004/1031 and S.I. 2005/2754. There are other amendments, but none is relevant.

Medical Devices (Consultation Requirements) (Fees) Regulations 1995U.K.

70.  In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 M82—U.K.

(a)in the definition “authorised medicinal product”—

(i)in sub-paragraph (b) before “under” insert “ the Human Medicines Regulations 2012 or ”, and

(ii)in sub-paragraph (c) for “those” substitute “ the latter ”; and

(b)in the definition “product licence of right” for “section 25(4) of that Act” substitute “ paragraph 3(2) of Schedule 32 to the Human Medicines Regulations 2012 ”.

Marginal Citations

Prescription Only Medicines (Human Use) Order 1997U.K.

71.—(1) The Prescription Only Medicines (Human Use) Order 1997 M83 is amended as follows.U.K.

(2) In article 1—

(a)in paragraph (2) omit all the defined expressions except “inhaler” and “maximum strength”;

(b)for paragraph (2A) substitute—

“(2A) In this Order, unless the context otherwise requires, any expression defined by any provision of the Human Medicines Regulations 2012 has the same meaning as it has for the purposes of those Regulations.”;

(c)in paragraph (5) for “Schedules 1, 2, 3A and 5” substitute “ Schedules 1 and 2 ”; and

(d)omit paragraphs (6) to (9).

(3) In article 5(1) for the words from the beginning of the paragraph until sub-paragraph (a) substitute “A medicinal product that is not the subject of a marketing authorisation is a prescription only medicine for the purposes of the Human Medicines Regulations 2012 if it, or a substance in it, is listed in column 1 of Schedule 1, unless there”.

(4) In paragraphs (1) and (2) of article 10 for the words “The restrictions” to “administration of” substitute “ A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is ”.

Marginal Citations

General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999U.K.

72.  In rule 7B(b) of the Schedule to the General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999 M84, for the words from “article” to the end of the paragraph substitute “ regulation 215 (prescribing and administration by supplementary prescribers) ” of the Human Medicines Regulations 2012.U.K.

Marginal Citations

M84S.I. 1999/3267, as amended by S.I. 2005/1476. There are other amendments, but none is relevant.

National Health Service (Charges for Drugs and Appliances) Regulations 2000U.K.

73.  The National Health Service (Charges for Drugs and Appliances) Regulations 2000 M85 are amended as follows—U.K.

F232(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)in regulation 6A(6) for the words from “the Medicines” to the end of the paragraph substitute “ the Human Medicines Regulations 2012 ”.

Textual Amendments

Marginal Citations

M85S.I. 2000/620, as amended by S.I. 2000/3189 and S.I. 2009/1166. There are other amendments, but none is relevant.

Biocidal Products Regulations 2001U.K.

74.  In Schedule 2 to the Biocidal Products Regulations 2001 M86—U.K.

(a)omit entry (f); and

(b)for entry (i) substitute—

“(i)the Human Medicines Regulations 2012;”.

Marginal Citations

M86S.I. 2001/880, as amended by S.I. 2010/745. There are other amendments, but none is relevant.

Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001U.K.

75.  In article 4(4) of the Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001 M87, for the words following “marketing authorisation” to the end of the paragraph substitute “ , certificate of registration, traditional herbal registration or Article 126a authorisation within the meaning of the Human Medicines Regulations 2012. ”U.K.

Marginal Citations

Misuse of Drugs Regulations 2001U.K.

76.  In regulation 2(1) of the Misuse of Drugs Regulations 2001 M88—U.K.

(a)in the definitions “clinical management plan”, “nurse independent prescriber”, “patient group direction”, “pharmacist independent prescriber”, “registered chiropodist”, “registered midwife”, “registered nurse”, “registered occupational therapist”, “registered optometrist”, “registered orthoptist”, “registered orthotist and prosthetist”, “registered paramedic”, “registered physiotherapist”, “registered radiographer” and “supplementary prescriber”, for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”; and

(b)in the definitions “pharmacist” and “registered pharmacy” for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

Marginal Citations

M88S.I. 2001/3998, as amended by S.I. 2003/2429, S.I. 2005/271, S.I. 2006/986, S.I. 2006/1450, S.I. 2007/2154 and 2012/973. There are other amendments, but none is relevant.

Medicines for Human Use (Kava-kava) (Prohibition Order) 2002U.K.

77.  In paragraph (d) of article 3 of the Medicines for Human Use (Kava-kava) (Prohibition Order) 2002 M89, for the words following “subject” to the end of the article substitute “ of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation within the meaning of the Human Medicines Regulations 2012. ”.U.K.

Marginal Citations

Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003U.K.

F23378.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003U.K.

79.  In the column “specified UK laws” of the Schedule to the Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003 M90 for “the Medicines (Advertising) Regulations 1994” substitute “ Chapters 1 and 2 of Part 14 (advertising) of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M90S.I. 2003/1374. There are amendments, but none is relevant.

Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003U.K.

80.  In the Schedule to the Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003 M91—U.K.

(a)in the first column, insert in the appropriate position in alphabetical order “ Human Medicines Regulations 2012 ”;

(b)in the second column, insert adjacent to the entry “ Human Medicines Regulations 2012 ” in the first column “regulation 303 (advertising offences)”; and

(c)omit “Medicines (Advertising) Regulations 1994” in the first column and the adjacent entry “regulation 23 (offences)” in the second column.

Marginal Citations

M91S.I. 2003/1376. There are amendments, but none is relevant.

Health Professions (Parts of and Entries in the Register) Order of Council 2003U.K.

81.  In article 6 of the Health Professions (Parts of and Entries in the Register) Order of Council 2003 M92—U.K.

(a)for sub-paragraph (b) of paragraph (2), up to and including the word “analgesics”, substitute—

“(b)referred to in the following provisions of Schedule 17 (exemption for sale, supply or administration by certain persons) to the Human Medicines Regulations 2012 —

(i)in Part 1 (exemption from restrictions on sale or supply of prescription only medicines), paragraph 11 (certificate of competence in the use of specified medicines), or

(ii)in Part 3 (exemptions from the restriction on administration of prescription only medicines), paragraph 1 (certificate in the use of analgesics),”; and

(b)in paragraph (3) for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”.

Marginal Citations

M92S.I. 2003/1571, as amended by S.I. 2006/1996. There are other amendments, but none is relevant.

Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003U.K.

82.—(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003 M93 (interpretation) are amended as follows.U.K.

(2) In regulation 1(2)—

(a)omit the following definitions—

(i)“the 1994 Regulations”, and

(ii)“herbal remedy”;

(b)before the definition of “the appropriate committee” insert—

““the 2012 Regulations” means the Human Medicines Regulations 2012;”.

(c)for the definition of “the appropriate committee” substitute—

““the appropriate committee” means whichever the appropriate Minister considers to be the appropriate body of the following—

(a)

the Commission; or

(b)

an expert committee appointed by the appropriate Minister, or by the appropriate Ministers for Great Britain and for Northern Ireland acting jointly;”;

(d)after the definition of “the appropriate Minister” insert—

““the Commission” means the Commission on Human Medicines continued in existence by regulation 9 of the 2012 Regulations;”;

(e)for the definition of “excluded medicine” substitute—

““excluded medicine” means a medicinal product to which the restrictions in regulation 46 (requirement for authorisation) of the 2012 Regulations do not apply by virtue of regulation 3(6) (scope of these Regulations: special provisions) or 4(1) (special provisions for pharmacies etc) of those Regulations;”;

(f)in the definition of “market” for the words from “have the same meaning” to the end substitute “ are to be construed in accordance with the 2012 Regulations; ”;

(g)for the definition of “medicinal product” substitute—

““medicinal product” has the meaning given by regulation 2 of the 2012 Regulations;”; and

(h)in the definition of “unlicensed product”—

(i)in paragraph (a)(i), for “the 1994 Regulations” substitute “ the 2012 Regulations ”,

(ii)omit paragraph (b) and the word “or” following it,

(iii)for paragraph (c) substitute—

“(c)no traditional herbal registration has been granted by the licensing authority under the 2012 Regulations;”, and

(iv)after that paragraph insert the word “ or ” and the following paragraph —

“(d)no Article 126a authorisation has been granted by the licensing authority under those regulations;”.

Marginal Citations

National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004U.K.

83.—(1) The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 M94 are amended as follows.U.K.

(2) In regulation 2(1)—

(a)omit the definition “the POM Order”; and

(b)in the definition “prescription only medicine” for the words from “article” to the end of the definition substitute “ regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012 ”.

(3) In paragraph 41(2)(a) of Schedule 5—

(a)for “article 3B(3) of the POM Order” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(b)for “that Order” substitute “ those Regulations ”.

Marginal Citations

M94S.S.I. 2004/115, as amended by S.S.I. 2005/337. There are other amendments, but none is relevant.

National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004U.K.

84.—(1) The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 M95 are amended as follows.U.K.

(2) In regulation 2(1)—

(a)omit the definition “the POM Order”; and

(b)in the definition “prescription only medicine” for the words from “article” to the end of the definition substitute “ regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012 ”.

(3) In paragraph 13(2)(a) of Schedule 1—

(a)for “article 3B(3) of the POM Order” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(b)for “that Order” substitute “ those Regulations ”.

Marginal Citations

M95S.S.I. 2004/116, as amended by S.S.I. 2005/336. There are other amendments, but none is relevant.

National Health Service (General Medical Services Contracts) Regulations 2004U.K.

F23485.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

National Health Service (General Medical Services Contracts) (Wales) Regulations 2004U.K.

86.—(1) The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004 M96 are amended as follows.U.K.

(2) In regulation 2—

(a)in paragraph (1)—

(i)omit the definition “the POM Order”; and

(ii)in the definition “prescription only medicine” for the words from “article” to the end of the definition substitute “ regulation 5(3) (classification of medicinal products) of the Human Medicines Regulations 2012 ”; and

(b)in paragraph (3) for “the POM Order” substitute “ the Human Medicines Regulations 2012 ”.

(3) In paragraph 43(2)(a) of Schedule 6—

(a)for “article 3B(3) of the POM Order” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(b)for “that Order” substitute “ those Regulations ”.

Marginal Citations

M96S.I. 2004/478, as amended by S.I. 2006/358 and S.I. 2010/1647. There are other amendments, but none is relevant.

National Health Service (Personal Medical Services Agreements) Regulations 2004U.K.

F23587.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004U.K.

88.  In Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004 M97 for “article 12F of the Prescription Only Medicines (Human Use) Order 1997 or article 8 of the Medicines (Pharmacy and General Sale- Exemptions) Order 1980”, in both places where those words occur, substitute “ regulation 247 (exemption for supply in the event or anticipation of pandemic disease) of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M97S.I. 2004/1022, as amended by S.I 2005/366 and S.I. 2009/1977. There are other amendments, but none is relevant.

Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004U.K.

89.—(1) The Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004 M98 is amended as follows.U.K.

(2) In article 2(1)—

(a)omit the definition “the 1994 Regulations”; and

(b)after the definition “the 2003 Act” insert the following definition—

““the 2012 Regulations” means the Human Medicines Regulations 2012;”.

(3) In article 7—

(a)in paragraph (1) for “the 1994 Regulations” substitute “ Chapter 3 (monitoring of advertising) of Part 14 of the 2012 Regulations ”; and

(b)in paragraph (2)—

(i)for “the 1994 Regulations” substitute “ the 2012 Regulations ”, and

(ii)for the words from “the following” to the end of the paragraph substitute “ regulation 314 of the 2012 Regulations ”.

(4) In article 8(3)(d) for “the 1994 Regulations” substitute “ Chapter 3 (monitoring of advertising) of Part 14 of the 2012 Regulations ”.

(5) In article 11—

(a)in paragraph (2) for “the 1994 Regulations” substitute “ the 2012 Regulations ”; and

(b)in paragraph (3)—

(i)for “section 1(1)(a) of the Medicines Act 1968” substitute “ regulation 6(6) of the 2012 Regulations ”, and

(ii)for “the 1994 Regulations” substitute “ Chapter 3 (monitoring of advertising) of Part 14 of the 2012 Regulations ”.

Marginal Citations

General Optical Council (Registration Rules) Order of Council 2005U.K.

90.  In the Table in rule 10 of the Schedule to the General Optical Council (Registration Rules) Order of Council 2005 M99—U.K.

(a)in entry B column 3—

(i)in paragraph (a) for “paragraph 6A of Schedule 5 to the Prescription Only Medicines (Human Use) Order 1997” substitute “ paragraph 8 of Part 1 of Schedule 17 of the Human Medicines Regulations 2012 ”, and

(ii)in paragraph (b) for “6B” substitute “ 9 ”;

(b)in entry C column 3 for “article 3B of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(c)in entry D column 3 for “article 3 of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 5(3) of the Human Medicines Regulations 2012 ”.

Marginal Citations

M99S.I. 2005/1478, as amended by S.I. 2008/1940. There are other amendments, but none is relevant.

National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007U.K.

91.—(1) The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007 M100 are amended as follows.U.K.

(2) In regulation 2(1) omit the definition of “the POM Order”.

(3) In regulation 2(2A) for “the POM Order” substitute “ the Human Medicines Regulations 2012 ”.

(4) In regulation 7(2) for the words from “the Medicines” to the end of the regulation substitute “ the Human Medicines Regulations 2012 ”.

(5) In regulation 7A(1)(b) for the words from “article 12F” to the end of the regulation substitute “ regulation 247 of the Human Medicines Regulations 2012 ”.

Marginal Citations

M100S.I. 2007/121, as amended by S.I. 2009/1175 and S.I. 2010/1647. There are other amendments, but none is relevant.

Human Tissue (Quality and Safety for Human Application) Regulations 2007U.K.

92.  In regulation 2(3) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 M101—U.K.

(a)omit sub-paragraph (a); and

(b)for sub-paragraph (b) substitute—

“(b)the Human Medicines Regulations 2012;”.

Marginal Citations

Legislative and Regulatory Reform (Regulatory Functions) Order 2007U.K.

93.—(1) The Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007 M102 is amended as follows.U.K.

(2) In Part 2 under the heading “Medicines”—

(a)omit the entries—

“Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994”,

“Medicines (Advertising) Regulations 1994”,

“Medicines (Monitoring of Advertising) Regulations 1994”,

“Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994”,

“Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005”, and

“Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005”; and

(b)add the entry—

“Human Medicines Regulations 2012”.

(3) In Part 3 under the heading “Public health and safety”—

(a)omit the entries—

“Medicines (Advertising) Amendment Regulations 2004”, and

“Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005”; and

(b)add the entry—

“Human Medicines Regulations 2012, in relation to Part 7 (traditional herbal registrations) of those Regulations”.

(4) In Part 6—

(a)omit the entry—

“Medicines (Advertising) Regulations 2005”; and

(b)add the entry—

“Human Medicines Regulations 2012, in relation to Chapters 1 and 2 of Part 14 (advertising) of those Regulations”.

(5) In Part 8—

(a)omit the entry—

“Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005”; and

(b)add the entry—

“Human Medicines Regulations 2012, in relation to Part 7 (traditional herbal registrations) of those Regulations”.

(6) In Part 13—

(a)omit the entry—

“Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005”; and

(b)add the entry—

“Human Medicines Regulations 2012, in relation to Part 7 (traditional herbal registrations) of those Regulations”.

Marginal Citations

M102S.I. 2007/3544, as amended by S.I. 2009/2981. There are other amendments, but none is relevant.

Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008U.K.

94.  In paragraph (d) of article 3 of the Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008 M103, for the words following “subject” to the end of the article substitute “ of a marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation within the meaning of the Human Medicines Regulations 2012. ”.U.K.

Marginal Citations

Specified Animal Pathogens Order 2008U.K.

95.  In article 5(2) of the Specified Animal Pathogens Order 2008 M104—U.K.

(a)in sub-paragraph (b) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”; and

(b)omit sub-paragraph (c).

Marginal Citations

M104S.I. 2008/944. There are amendments, but none is relevant.

Specified Animal Pathogens (Wales) Order 2008U.K.

96.  In article 5(2) of the Specified Animal Pathogens (Wales) Order 2008 M105—U.K.

(a)in sub-paragraph (b) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”; and

(b)omit sub-paragraph (c).

Marginal Citations

M105S.I. 2008/1270. There are amendments, but none is relevant.

Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008U.K.

97.  In regulation 1(2) of the Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008 M106 in the definition “prescription only medicine”, for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M106S.I. 2008/3258. There are amendments, but none is relevant.

Specified Animal Pathogens (Scotland) Order 2009U.K.

98.  In article 5(2) of the Specified Animal Pathogens (Scotland) Order 2009 M107—U.K.

(a)in sub-paragraph (b) for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;” substitute “ the Human Medicines Regulations 2012. ”; and

(b)omit sub-paragraph (c).

Marginal Citations

M107S.S.I. 2009/45. There are amendments, but none is relevant.

National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009U.K.

99.—(1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 M108 are amended as follows.U.K.

(2) In regulation 2(1)—

(a)in the definition “clinical management plan” for the words from “article” to the end of the definition substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”;

(b)in the definition “non-proprietary name”—

(i)for “section 103(5) of the 1968 Act” in both places where it occurs substitute “regulation 321(3) of the Human Medicines Regulations 2012, and

(ii)for “section 100 of that Act” substitute “ regulation 318 of those Regulations ”;

(c)in the definition “Patient Group Direction” for the words from “Article” to the end of the definition substitute “ regulation 213 of the Human Medicines Regulations 2012 ”; and

(d)in the definition “supply form” for the words from “Article” to the end of the definition substitute “ regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012 ”.

(3) In Schedule 1—

(a)in paragraph 4—

(i)in sub-paragraph (23) for “Article 12C of the Prescription Only Medicines (Human Use) Order 1997 (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction)” substitute “ regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012 ”; and

(ii)in sub-paragraph (29) for “paragraph (4) of article 8 of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 225 (emergency sale etc by pharmacist: at patient's request) of the Human Medicines Regulations 2012 ”; and

(b)in paragraph 10(8) for “article 12C of the Prescription Only Medicines (Human Use) Order 1997, (exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction)” substitute “ regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012, ”.

Marginal Citations

Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009U.K.

100.—(1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009 M109 is amended as follows.U.K.

(2) In Part 1 of Schedule 1, to the entry “Medicines Act 1968 (section 109)” add “or Human Medicines Regulations 2012 (regulation 323)”.

(3) In Part 2 of Schedule 1—

(a)omit the entry—

“Medicines (Advertising) Regulations 1994”; and

(b)add in the appropriate place the entry—

“Human Medicines Regulations 2012, in relation to Chapters 1 and 2 of Part 14 (advertising) of those Regulations”.

(4) In Part 4 of Schedule 1—

(a)omit the entry—

“Medicines (Traditional Herbal Medicinal Products for human use) Regulations 2005”; and

(b)add in the appropriate place the entry—

“Human Medicines Regulations 2012, in relation to Part 7 (traditional herbal registrations) of those Regulations”.

(5) In Part 2 of Schedule 2—

(a)omit the entry—

“Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005”; and

(b)add the entry—

“Human Medicines Regulations 2012, in relation to Part 7 (traditional herbal registrations) of those Regulations”.

Marginal Citations

M109S.I. 2009/669. There are amendments, but none is relevant.

Single Use Carrier Bags Charge (Wales) Regulations 2010U.K.

101.  In Schedule 1(3) to the Single Use Carrier Bags Charge (Wales) Regulations 2010 M110—U.K.

(a)in the definition “EEA health professional” for the words from “1(2)” to the end of the definition substitute “ 213(1) of the Human Medicines Regulations 2012 ”;

(b)in the definition “pharmacy medicine” for the words from “means” to the end of the definition substitute “ has the meaning given in regulation 5(5) of the Human Medicines Regulations 2012 ”;

(c)in the definition “prescription only medicine” for the words from “means” to the end of the definition substitute “ has the meaning given in regulation 5(3) of the Human Medicines Regulations 2012 ”; and

(d)in the definition beginning “supplementary prescriber” for “article 1(2) of the Prescription Only Medicines (Human Use) Order 1997” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.

Marginal Citations

M110S.I. 2010/2880. There are amendments, but none is relevant.

PART 6U.K.Northern Ireland statutory rules

Control of Pesticides Regulations (Northern Ireland) 1987U.K.

102.  For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern Ireland) 1987 M111 substitute—U.K.

“(i)the Human Medicines Regulations 2012;”.

Marginal Citations

M111S.R. (NI) 1987 No 414, as amended by S.R. (NI) 1997 No 469.

Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995U.K.

103.  In rule 4 of the Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995 M112—U.K.

(a)omit the definition “the 1997 Order”;

(b)in the definitions “nurse independent prescriber” and “pharmacist independent prescriber” for “article 1(2) of the 1997 Order” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”; and

(c)in the definition “prescription only medicine” for “article 1(2) of the 1997 Order” substitute “ regulation 5(3) of the Human Medicines Regulations 2012 ”.

Marginal Citations

M112S.R. (NI) 1995 No 8, as amended by S.R. (NI) 2009 No 429. There are other amendments, but none is relevant.

Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996U.K.

104.  In the Schedule to the Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996 M113 for “Medicines Act 1968” substitute “ Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M113S.R. (NI) 1996 No 81.

Pharmaceutical Services Regulations (Northern Ireland) 1997U.K.

105.  In Part 2 of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997 M114, in paragraph 2(12) for the words from “Articles” to the end of the paragraph substitute regulation 224 of the Human Medicines Regulations 2012”.U.K.

Marginal Citations

M114S.R. (NI) 1997 No 381, as amended by S.R. (NI) 1999 No 405. There are other amendments, but none is relevant.

Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998U.K.

106.  In Schedule 1, Chapter 4, Section 4.8, Part C of the Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998 M115, for the words from “means” to the end of the Part substitute “ has the meaning given in regulation 2 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M115S.R. (NI) 1998 No 28.

Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998U.K.

107.  The Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998 M116 are amended as follows—U.K.

(a)in regulation 10(1)(a) for “section 8 of the Medicines Act 1968” substitute “ regulation 17 of the Human Medicines Regulations 2012 ”; and

(b)in regulation 11(1) for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

Marginal Citations

M116S.R. (NI) 1998 No 45, as amended by S.R. (NI) 2011 No 124.

Importation of Animal Pathogens Order (Northern Ireland) 1999U.K.

108.  In article 5(a) of the Importation of Animal Pathogens Order (Northern Ireland) 1999 M117 for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M117S.R. (NI) 1999 No 433.

Biocidal Products Regulations (Northern Ireland) 2001U.K.

109.  In Schedule 2 to the Biocidal Products Regulations (Northern Ireland) 2001 M118—U.K.

(a)omit entry (f); and

(b)for entry (i) substitute—

“(i)the Human Medicines Regulations 2012;”.

Marginal Citations

M118S.R. (NI) 2001 No 422.

Misuse of Drugs Regulations (Northern Ireland) 2002U.K.

110.—(1) The Misuse of Drugs Regulations (Northern Ireland) 2002 M119 are amended as follows.U.K.

(2) In regulation 2(2)—

(a)in the definitions “clinical management plan”, “nurse independent prescriber”, “patient group direction”, “registered chiropodist”, “registered midwife”, “registered nurse”, “registered occupational therapist”, “registered optometrist”, “registered orthoptist”, “registered orthotist and prosthetist”, “registered paramedic”, “registered physiotherapist”, “registered radiographer” and “supplementary prescriber”, for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”; and

(b)in the definition “medicinal product” for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”

(3) In regulation 6A(1)(e) for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

(4) In regulation 8(2)—

(a)in sub-paragraph (h) after the first occurrence of “the Medicines Act 1968” insert “ or of Schedule 31 to the Human Medicines Regulations 2012 ”; and

(b)in sub-paragraph (j) after “the Medicines Act 1968” insert “ or of regulation 324 of the Human Medicines Regulations 2012 ”.

(5) In regulation 9(2)—

(a)in sub-paragraph (f) after “the Medicines Act 1968” insert “ or of Schedule 31 to the Human Medicines Regulations 2012 ”; and

(b)in sub-paragraph (h) after “the Medicines Act 1968” insert “ or of regulation 324 of the Human Medicines Regulations 2012 ”.

(6) In regulation 11(1) for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.

(7) In regulation 17—

(a)after “the Medicines Act 1968” insert “ or of the Human Medicines Regulations 2012 ”; and

(b)after “that Act” insert “ or of those Regulations ”.

(8) In regulation 18 for paragraph (3) substitute—

“(3) In this regulation, “clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2004.”.

Marginal Citations

M119S.R. (NI) 2002 No 1, as amended by S.R. (NI) 2003 No 324, S.R. (NI) 2003 No 420, S.R. (NI) 2005 No 119, S.R. (NI) 2005 No 564, S.R. (NI) 2006 No 214, S.R. (NI) 2006 No 264, and S.R. (NI) 2007 No 348.

Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003U.K.

111.  In regulation 5(2)(c) of the Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003 M120 for “section 58 of the Medicines Act 1968” substitute “ regulation 214 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M120S.R. (NI) 2003 No 34.

Waste Management Licensing Regulations (Northern Ireland) 2003U.K.

112.  In paragraph 2 of Schedule 1 to the Waste Management Licensing Regulations (Northern Ireland) 2003 M121, in the definition “hazardous waste” for the words following “ “medicinal product” means” to the end of the definition substitute “ a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M121S.R. (NI) 2003 No 493.

Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004U.K.

113.—(1) The Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004 M122 are amended as follows.U.K.

(2) In regulation 2—

(a)in the definition “licensing authority” for “section 6(3) of the Medicines Act 1968” substitute “ regulation 6 of the Human Medicines Regulations 2012 ”;

(b)omit the definition “the POM Order” and

(c)in the definition “prescription only medicine” for the words from “referred” to the end of the definition substitute “ within the meaning of regulation 5(3) of the Human Medicines Regulations 2012 ”.

(3) In regulation 47(2) for the words from “Part 3” to the end of the regulation substitute “ Part 12 of the Human Medicines Regulations 2012 ”.

(4) In Schedule 5—

(a)in paragraph 11A(1) in the definition “Patient Group Direction” for “the Prescription Only Medicines (Human Use) Order 1997” substitute “ the Human Medicines Regulations 2012 ”; and

(b)in paragraph 41(2)(a)—

(i)for “article 3B(3) of the POM Order” substitute “ regulation 215 of the Human Medicines Regulations 2012 ”; and

(ii)for “that Order” substitute “ those Regulations ”.

Marginal Citations

M122S.R. (NI) 2004 No 140, as amended by S.R. (NI) 2005 No 368.

Nursing Homes Regulations (Northern Ireland) 2005U.K.

114.  In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland) 2005 M123 for “section 58 of the Medicines Act 1968” substitute “ regulation 214 or 215 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M123S.R. (NI) 2005 No 160.

Residential Care Homes Regulations (Northern Ireland) 2005U.K.

115.  In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland) 2005 M124 for “section 58 of the Medicines Act 1968” substitute “ regulation 214 or 215 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M124S.R. (NI) 2005 No 161.

Children's Homes Regulations (Northern Ireland) 2005U.K.

116.  In regulation 20(4)(b) of the Children's Homes Regulations (Northern Ireland) 2005 M125, for “section 58 of the Medicines Act 1968” substitute “ regulations 214 or 215 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M125S.R. (NI) 2005 No 176.

Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006U.K.

117.  In regulation 3(1) of the Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006 M126 in the definition “Pharmacist” for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M126S.R. (NI) 2006 No 478.

Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007U.K.

118.  In regulation 71(3)(a) of the Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007 M127, for “section 8(2) of the Medicines Act 1968” substitute “ regulation 17 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M127S.R. (NI) 2007 No 68.

Day Care Setting Regulations (Northern Ireland) 2007U.K.

119.  In regulation 13(6)(b) of the Day Care Setting Regulations (Northern Ireland) 2007 M128 for “section 58 of the Medicines Act 1968” substitute “ regulations 214 or 215 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M128S.R. (NI) 2007 No 234.

Residential Family Centres Regulations (Northern Ireland) 2007U.K.

120.  In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern Ireland) 2007 M129 for “section 58 of the Medicines Act 1968” substitute “ regulations 214 or 215 of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M129S.R. (NI) 2007 No 236.

Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007U.K.

121.  In regulation 3(1)(a) of the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007 M130 for “the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M130S.R. (NI) 2007 No 420.

Specified Animal Pathogens Order (Northern Ireland) 2008U.K.

122.  In article 5(2)(b) of the Specified Animal Pathogens Order (Northern Ireland) 2008 M131 for “the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M131S.R. (NI) 2008 No 336.

Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009U.K.

123.  In regulation 2(2) of the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 M132, in the definition “retail pharmacy business” for “section 132 of the Medicines Act 1968” substitute “ regulation 8(1) of the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M132S.R. (NI) 2009 No 225.

Private Water Supplies Regulations (Northern Ireland) 2009U.K.

124.  In regulation 4(b) of the Private Water Supplies Regulations (Northern Ireland) 2009 M133 for “the Medicines Act 1968” substitute “ the Human Medicines Regulations 2012 ”.U.K.

Marginal Citations

M133S.R. (NI) 2009 No 413.

Regulation 349

SCHEDULE 35U.K.Repeals and revocations

Enactment or instrumentExtent of repeal or revocation
Medicines Act 1968 (c. 67)

Sections 2A to 9.

Section 10(7).

Sections 11 to 14.

Section 15(1) and (2).

Sections 16 to 57.

Section 58(1A), (2) and (3).

Sections 59 to 61.

Sections 65 and 66.

Section 67(3A), (5) and (6).

Section 68.

Sections 85 and 86.

Section 89.

Section 91(1).

Sections 92 to 103.

Section 108(3) to (5) and (7).

Section 109(3).

Section 110(3).

Section 111(3).

Section 112(7).

Sections 115 and 116.

Section 126(4).

Section 130(2) to (8) and (10).

Section 132(2), (3) and (5).

Schedules 1A and 2.

In Schedule 3, paragraphs 5 to 7.

Medicines (Extension to Antimicrobial Substances) Order 1973 (S.I. 1973/367)The whole Order.
Medicines (Specified Articles and Substances) Order 1976 (S.I. 1976/968)The whole Order.
Medicines (Fluted Bottles) Regulations 1978 (S.I. 1978/40)The whole of the Regulations.
Medicines (Medicines Act 1968 Amendment) Regulations 1983 (S.I. 1983/1724)The whole of the Regulations.
Medicines (Products Other than Veterinary Drugs) (General Sale List) Amendment Order 1990 (S.I. 1990/1129)The whole Order.
Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 (S.I. 1992/605)The whole of the Regulations.
Medicines Act 1968 (Amendment) Regulations 1993 (S.I. 1993/834)The whole of the Regulations.
Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S.I. 1994/105)The whole of the Regulations.
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994 (S.I. 1994/899)The whole of the Regulations.
Medicines (Advertising) Regulations 1994 (S.I. 1994/1932)The whole of the Regulations.
Medicines (Monitoring of Advertising) Regulations 1994 (S.I. 1994/1933)The whole of the Regulations.
Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144)The whole of the Regulations.
Medicines Act 1968 (Amendment) Regulations 1995 (S.I. 1995/2321)The whole of the Regulations.
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996 (S.I. 1996/482)The whole of the Regulations.
Prescription Only Medicines (Human Use) Order 1997 (S.I. 1997/1830)The whole of the Order except articles 1(1) to (5), 5 and 10 and Schedules 1 and 2.
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 1998 (S.I. 1998/3105)The whole of the Regulations.
Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/267)The whole of the Regulations.
Medicines (Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999/784)The whole of the Regulations.
Medicines (Codification Amendments Etc.) Regulations 2002 (S.I. 2002/236)The whole of the Regulations
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003 (S.I. 2003/1618)The whole of the Regulations.
Medicines (Child Safety) Regulations 2003 (S.I. 2003/2317)The whole of the Regulations.
Medicines (Advertising) Amendment Regulations 2004 (S.I. 2004/1480)The whole of the Regulations.
Medicines for Human Use (Prescribing) Order 2005 (S.I. 2005/765)The whole Order.
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/768)The whole of the Regulations.
Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094)The whole of the Regulations except paragraph 12(1), (4) and (5) of Schedule 1, and regulation 8 as it relates to those paragraphs.
Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1520)The whole of the Regulations.
Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/1710)The whole of the Regulations.
Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750)The whole of the Regulations except paragraph 8(a)(i) and (b) of Schedule 7, and regulation 12 as it relates to those paragraphs.
Medicines (Advisory Bodies) (No 2) Regulations 2005 (S.I. 2005/2754)The whole of the Regulations, except Schedule 3, and regulation 4 as it relates to that Schedule, and paragraphs 3 and 7(1) and (3) of Schedule 4, and regulation 5 as it relates to those paragraphs.
Medicines (Advertising Amendments) Regulations 2005 (S.I. 2005/2787)The whole of the Regulations.
Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789)The whole of the Regulations.
Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006 (S.I. 2006/395)The whole of the Regulations.
Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 (S.I. 2006/1952)The whole of the Regulations.
Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 (S.I. 2008/1692)The whole of the Regulations.
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (S.I. 2008/3097)The whole of the Regulations.
Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 (S.I. 2009/1164)The whole of the Regulations, except regulation 3.
Medicines (Exemptions and Miscellaneous Amendments) Order 2009 (S.I. 2009/3062)The whole Order.
Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)The whole of the Regulations.

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