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PART 10U.K.Exceptions to requirement for marketing authorisation etc

ExceptionsU.K.

Supply to fulfil special patient needsU.K.

167.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product (a “special medicinal product”) if—

(a)the medicinal product is supplied in response to an unsolicited order;

(b)the medicinal product is manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

(c)the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and

(d)the following conditions are met.

(2) Condition A is that the medicinal product is supplied—

(a)to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or

(b)for use under the supervision of a pharmacist in a registered pharmacy, a hospital or a health centre.

(3) Condition B is that no advertisement relating to the medicinal product is published by any person.

(4) Condition C is that—

(a)the manufacture and assembly of the medicinal product are carried out under such supervision; and

(b)such precautions are taken,

as are adequate to ensure that the medicinal product meets the specification of the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber who requires it.

(5) Condition D is that written records of the manufacture or assembly of the medicinal product in accordance with condition C are maintained and are available to the licensing authority or to the enforcement authority on request.

(6) Condition E is that if the medicinal product is manufactured or assembled in the United Kingdom [F1, imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland]—

(a)it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products; or

(b)it is manufactured, assembled or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the licensing authority for the purposes of regulation 36 of the Clinical Trials Regulations.

(7) Condition F is that if the product is [F2imported into Northern Ireland from an EEA State or imported into Great Britain from a country other than an approved country for import]—

[F3(a)it is manufactured or assembled in that State or country (as appropriate) by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i)in the case of a product for sale or supply in Northern Ireland, the provisions of the 2001 Directive as implemented in that State, and

(ii)in the case of a product for sale or supply in Great Britain, in accordance with the provisions applicable in that country; or]

[F4(b)it is manufactured or assembled as an investigational medicinal product in that State or country (as appropriate) by the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i)in the case of a product for sale or supply in Northern Ireland, Article 13 of the Clinical Trials Directive as implemented in that State, and

(ii)in the case of a product for sale or supply in Great Britain, regulations 13 and 43 of the Clinical Trials Regulations,]

[F5and it is imported by the holder of a wholesale dealer’s licence in relation to the product in question.]

(8) Condition G is that if the product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product in accordance with paragraph (6)(a) or (7)(a), P must be the holder of a wholesale dealer's licence in relation to the product in question.

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Textual Amendments

F5Words in reg. 167(7)(b) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 5(2)(b) and words in reg. 167(7)(b) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 5(2)(b)

Use of non-prescription medicines in the course of a businessU.K.

168.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to anything done in relation to a medicinal product if the following conditions are met.

(2) Condition A is that the medicinal product is not a prescription only medicine.

(3) Condition B is that the medicinal product is sold or supplied to a person who is a health care professional (“P”) exclusively for use by P—

(a)in the course of a business carried on by P, and

(b)for the purposes of administering it or causing it to be administered otherwise than by selling it.

(4) Condition C is that the medicinal product is—

(a)manufactured and assembled in accordance with the specification of P; and

(b)for use by a patient for whose treatment P is directly responsible in order to fulfil the special needs of that patient

(5) Condition D is that if sold or supplied through the holder of a wholesale dealer's licence the medicinal product is sold or supplied to such a person and for such use as mentioned in condition B.

(6) Condition E is that no advertisement relating to the medicinal product is published by any person.

(7) Condition F is that the sale or supply of the medicinal product is in response to an unsolicited order.

[F6(8) Condition G is that if the medicinal product is—

(a)manufactured or assembled in the United Kingdom or imported into the United Kingdom from—

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

(ii)in the case of a product for sale or supply in Great Britain, a country other than an approved country for import,

it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products, or

(b)imported into—

(i)Northern Ireland from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii)Great Britain from an approved country for import—

(aa)it is manufactured or assembled in that country by a person who is the holder of an authorisation in that country in relation to its manufacture or assembly, and

(bb)it is imported by the holder of a wholesale dealer's licence under Part 3 that includes the import of a medicinal product from such a country.]

(9) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

Textual Amendments

Mixing of general sale medicinal productsU.K.

169.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to a medicinal product (“the product”) in respect of which the following conditions are met.

(2) Condition A is that the product is manufactured by the mixing of authorised medicinal products with other authorised medicinal products, or with substances that are not medicinal products.

(3) Condition B is that any authorised medicinal product that is so mixed is subject to general sale.

(4) Condition C is that the product is manufactured by a person (“H”) who is the holder of a manufacturer's licence that—

(a)relates specifically to the manufacture of medicinal products in accordance with this regulation; and

(b)was granted or renewed not more than five years before the date on which the product is sold or supplied in accordance with paragraphs (5) and (6),

and that the product is manufactured in accordance with the terms of that licence.

(5) Condition D is that the product is sold or supplied by H to a person (“P”) for administration to P or to a member of P's household.

(6) Condition E is that P is present and asks H to use H's judgment as to the treatment required.

(7) Condition F is that no advertisement relating to the product is published by any person.

(8) Condition G is that written records of the manufacture of the product and of the sale or supply of the product are maintained and are made available to the licensing authority or to the enforcement authority on request.

(9) In this regulation, “authorised medicinal product” means a medicinal product that is the subject of—

(a)a [F7UK marketing authorisation or EU marketing authorisation];

(b)a certificate of registration; or

(c)a traditional herbal registration.

Textual Amendments

Record-keeping requirementsU.K.

170.—(1) Where the sale or supply of a medicinal product relies on the exemptions under regulations 167, 168 or, subject to paragraph (4), 169, the person who sells or supplies the product must maintain for at least five years a record showing—

(a)the source from which and the date on which the person obtained the product;

(b)the person to whom and the date on which the sale or supply was made;

(c)the quantity of the sale or supply;

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

(e)details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

(2) The person must make the records available for inspection by the licensing authority on request.

(3) The person must notify the licensing authority of any suspected adverse reaction to the medicinal product which is a serious adverse reaction.

(4) In the case of a medicinal product that is sold or supplied in reliance on the exemption in regulation 169—

(a)the reference in paragraph (1)(a) to “the product” means all the medicinal products that were mixed in the course of the manufacture of the product; and

(b)paragraph (1)(d) shall not apply.

Exempt advanced therapy medicinal productsU.K.

171.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an advanced therapy medicinal product (an “exempt advanced therapy medicinal product”) if the following conditions are met.

(2) Condition A is that the product is prepared—

(a)on a non-routine basis;

(b)in the United Kingdom; and

(c)according to specific quality standards equivalent to those provided for advanced therapy medicinal products authorised under [F8—

(i)in the case of a product for sale or supply in Northern Ireland, Regulation (EC) No 726/2004, and

(ii)in the case of a product for sale or supply in Great Britain, regulation 49(1).]

(3) Condition B is that the product is used—

(a)in a hospital in the United Kingdom;

(b)under the exclusive professional responsibility of a doctor; and

(c)in order to comply with an individual medical prescription for a product made to order for an individual patient.

(4) Condition C is that no advertisement relating to the medicinal product is published by any person.

(5) Condition D is that the sale or supply of the medicinal product is in response to an unsolicited order.

(6) In this regulation “publish” has the meaning given in regulation 277(1) (interpretation Part 14 advertising).

Textual Amendments

F8Reg. 171(2)(c)(i)(ii) substituted for words in reg. 171(2)(c) (31.12.2020) by S.I. 2019/775, reg. 137 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 105); 2020 c. 1, Sch. 5 para. 1(1)

Parallel import licencesU.K.

172.—(1) The prohibitions in regulation 46 (requirement for authorisation) do not prevent—

(a)the holder of a parallel import licence from placing the medicinal product to which the licence relates on the market; or

(b)the sale or supply, or offer for sale or supply, of a medicinal product to which a parallel import licence relates, in accordance with the terms of that licence.

[F9(2) In this regulation “parallel import licence” has the same meaning as in regulation 48(2).]

Textual Amendments

Exemption for certain radiopharmaceuticalsU.K.

173.  Regulation 46 (requirement for authorisation) does not apply where a radiopharmaceutical is prepared—

(a)at the time when it is intended to be administered;

(b)in accordance with the manufacturer's instructions and by the person by whom it is to be administered;

(c)from radionuclide generators, radionuclide kits and radionuclide precursors in respect of which a [F10UK marketing authorisation or EU marketing authorisation] is in force; and

[F11(d)for administration—

(i)in England and Wales and Scotland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(ii)in Northern Ireland in accordance with a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.]

Textual Amendments

Supply in response to spread of pathogenic agents etcU.K.

174.  The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—

(a)pathogenic agents;

(b)toxins;

(c)chemical agents; or

(d)nuclear radiation,

which may cause harm to human beings.

[F12Conditions of temporary authorisations under regulation 174U.K.

174A.—(1) Where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis under regulation 174, the licensing authority may attach conditions to that authorisation, those being conditions to which the following are subject—

(a)its recommendation or requirement as to the use of that product for the purposes of regulation 345; and

(b)its authorisation of the sale or supply of that product.

(2) The sale or supply of that medicinal product is not authorised by the licensing authority for the purposes of regulation 174 if—

(a)the sale or supply is for the purpose of any use other than the recommended or required use, as mentioned in paragraph (1)(a); or

(b)a condition attached in accordance with paragraph (1) to the authorisation of the sale or supply is breached.

(3) The use of that medicinal product is not in accordance with a recommendation or requirement of the licensing authority for the purposes of regulation 345 if—

(a)a condition attached in accordance with paragraph (1) to the authorisation of its sale or supply is breached; and

(b)any risk of death or personal injury that is wholly or partly attributable to that breach is such that a reasonable person with relevant expertise in the subject matter of the breach would regard the breach as sufficiently serious to justify the licensing authority setting aside the recommendation or requirement.

(4) Notwithstanding paragraph (3), the persons mentioned in regulation 345(3) are not subject to any civil liability resulting from a use of that medicinal product that was (but for the operation of that paragraph) in accordance with the recommendation or requirement of the licensing authority, if those persons were not wholly or partly responsible for the breach in question.

(5) As soon as is reasonably practical after the end of one year beginning on the day on which the first conditions are attached in accordance with paragraph (1), the Secretary of State must—

(a)review the operation of this regulation with a view to evaluating whether there have been any adverse consequences for the market in medicines or for patient safety as a consequence of the operation of this regulation;

(b)set out the conclusions of the review in a report; and

(c)publish the report.]

Textual Amendments