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PART 3U.K.[F1Manufacture and distribution of medicinal products and active substances]

Textual Amendments

F1 Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4

[F2CHAPTER 2]U.K.Manufacturing and wholesale dealing

Textual Amendments

Conditions for holding a wholesale dealer's licenceU.K.

Conditions for wholesale dealer's licenceU.K.

42.—(1) Regulations 43 to 45 [F3(not including regulation 43ZA)] [F4(in the case of a wholesale dealer’s licence held in Northern Ireland) or regulations 43 to 45AA [F5(including regulation 43ZA)] (in the case of a wholesale dealer’s licence held in Great Britain)] apply to the holder of a wholesale dealer's licence (referred to in those regulations as “the licence holder”) and have effect as if they were provisions of the licence (but the provisions specified in paragraph (2) do not apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products).

[F6(2) Those provisions are regulations 43(2) and (8) and 44.]

(3) The requirements in Part 2 of Schedule 6 apply to the holder of a wholesale dealer's licence insofar as the licence relates to exempt advanced therapy medicinal products, and have effect as if they were provisions of the licence.

[F7(4) [F8Where a wholesale dealer’s licence relates to wholesale dealings in Northern Ireland, the requirements] and obligations contained in a provision of Commission Regulation 2016/161 listed in paragraph (5) have effect as if they were [F9provisions of that] licence under this Part.

(5) The provisions mentioned in paragraph (4) are—

(a)Article 10 (verification of the safety features) insofar as it relates to wholesalers;

(b)Article 11 (verification of the authenticity of the unique identifier) insofar as it relates to wholesalers;

(c)Article 12 (unique identifiers which have been decommissioned);

(d)Article 13 (reversing the status of a decommissioned unique identifier) insofar as it relates to wholesalers;

(e)Article 20 (verification of the authenticity of the unique identifier), subject to the exemption contained in Article 21 (derogations from Article 20(b));

(f)Article 22 (decommissioning of unique identifiers); and

(g)Article 24 (actions to be taken in case of tampering or suspected falsification).]

[F10(6) Paragraph (4) does not apply in relation to listed NIMAR products in Northern Ireland.]

Textual Amendments

Obligations of licence holderU.K.

43.—[F11(1) The licence holder must comply with the guidelines on good distribution practice—

(a)in the case of a licence holder in Great Britain, published under, or that apply by virtue of, regulation C17;

(b)in the case of a licence holder in Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive.]

(2) The licence holder must ensure, within the limits of the holder's responsibility, the continued supply of medicinal products to pharmacies, and other persons who may lawfully sell medicinal products by retail or supply them in circumstances corresponding to retail sale, so that the needs of patients in the United Kingdom are met.

(3) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of medicinal products under the licence as are necessary—

(a)to maintain the quality of the products; and

(b)to ensure their proper distribution.

(4) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(5) Subject to paragraph (6), the licence holder must not sell or supply a medicinal product, or offer it for sale or supply, unless—

[F12(a)in the case of a product for sale or supply—

(i)in Great Britain, there is a UKMA(GB), UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii)in Northern Ireland, there is a UKMA(NI), UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK), and EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and]

(b)the sale or supply, or offer for sale or supply, is in accordance with the authorisation.

(6) The restriction in paragraph (5) does not apply to—

(a)the sale or supply, or offer for sale or supply, of a special medicinal product [F13in the United Kingdom];

(b)the export [F14from Northern Ireland] to an EEA State, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that State without a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration by virtue of legislation adopted by that State under Article 5(1) of the 2001 Directive; F15...

[F16(ba)the export from Great Britain to an approved country for import, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that country without—

(i)a marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the 2001 Directive, by virtue of legislation adopted by that country under Article 5(1) of that Directive, where the approved country for import is an EEA State, or

(ii)such equivalent authorisation, certificate or registration in the approved country for import, under legislation in that country that makes provision that is equivalent to Article 5(1) of the 2001 Directive, where the approved country for import is not an EEA State.]

(c)the sale or supply, or offer for sale or supply, of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of the product under regulation 174; [F17or

[F18(d)the wholesale distribution of medicinal products—

(i)from Northern Ireland to a person in a country other than Great Britain or a country other than an EEA State; or

(ii)from Great Britain to a person in a country other than Northern Ireland or a country other than an approved country for import.]

(7) The licence holder must—

(a)keep documents relating to the sale or supply of medicinal products under the licence which may facilitate the withdrawal or recall from sale of medicinal products in accordance with paragraph (b);

(b)maintain an emergency plan to ensure effective implementation of the recall from the market of a medicinal product where recall is—

[F19(i)ordered by the licensing authority or—

(aa)in the case of a licence holder in Great Britain, by an appropriate authority for the licensing of medicinal products in an approved country for import;

(bb)in the case of a licence holder in Northern Ireland, by the competent authority of any EEA State, or]

[F20(ii)carried out in co-operation with the manufacturer of, or the holder of—

(aa)in the case of a product for sale or supply in Great Britain, the UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration, or

(bb)in the case of a product for sale or supply in Northern Ireland, the UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and]

[F21(c)keep records in relation to the receipt, dispatch or brokering of medicinal products, of—

(i)the date of receipt,

(ii)the date of despatch,

(iii)the date of brokering,

(iv)the name of the medicinal product,

(v)the quantity of the product received, dispatched or brokered,

(vi)the name and address of the person from whom the products were received or to whom they are dispatched,

(vii)[F22where the receipt, dispatch or brokering of medicinal products takes places in Northern Ireland,] the batch number of medicinal products bearing safety features referred to in point (o) of Article 54 of the 2001 Directive.]

[F21(8) A licence holder [F23in Northern Ireland] (“L”) who imports from another EEA State a medicinal product in relation to which L is not the holder of a marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration shall—

(a)notify the intention to import that product to the holder of the authorisation and—

(i)in the case of a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004, to the EMA; or

(ii)in any other case, the licensing authority; and

(b)pay a fee to the EMA in accordance with Article 76(4) of the 2001 Directive or the licensing authority as the case may be, in accordance with the Fees Regulations,

but this paragraph does not apply in relation to the wholesale distribution of medicinal products to a person in a [F24country other than an EEA State].]

[F25(8A) Paragraph (8B) applies to a person (“P”) who—

(a)imports into Great Britain a medicinal product, other than for the sole purpose of wholesale distribution of that product to a person in a country other than the United Kingdom; but

(b)is not the holder of a UK marketing authorisation, certificate of registration or traditional herbal registration in respect of that product.

(8B) Where this paragraph applies, P must—

(a)notify—

(i)the holder of any authorisation, certificate or registration, granted by an authority in the country from which the product is exported, to sell or supply that product in that country, and

(ii)the licensing authority,

of the intention to import that product; and

(b)pay a fee to the licensing authority in accordance with the Fees Regulations.]

(9) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

[F26(10) The holder [F27of a licence relating to wholesale dealings in Northern Ireland] (“L”) must verify in accordance with paragraph (11) that any medicinal products received by L that are required by Article 54a of the Directive to bear safety features are not falsified but this paragraph does not apply in relation to the distribution of medicinal products received from a third country by a person to a person in a third country.

(11) Verification under this paragraph is carried out by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts adopted under Article 54a(2) of the 2001 Directive.

(12) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(13) The licence holder must immediately inform the licensing authority and, where applicable, the [F28UK marketing authorisation holder or EU marketing authorisation holder], of medicinal products which the licence holder receives or is offered which the licence holder—

(a)knows or suspects; or

(b)has reasonable grounds for knowing or suspecting,

to be falsified.

(14) [F29Where the medicinal product is obtained through brokering—

(a)a licence holder in Great Britain must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b);

(b)a licence holder in Northern Ireland must verify that the broker involved is validly registered with the licensing authority or the competent authority of an EEA State.]

(15) In this regulation [F30as it applies in the case of a product for sale or supply in Northern Ireland], “marketing authorisation” means—

(a)a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; or

(b)an EU marketing authorisation.]]

Textual Amendments

F15Word in reg. 43(6)(b) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 6(2)(a) and word in reg. 43(6)(b) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 6(2)(a)

F17Reg. 43(6)(d) and preceding word inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 6(2)(b) and reg. 43(6)(d) and preceding word inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 6(2)(b)

F26Reg. 43(10)-(15) substituted for reg. 43(10) (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 14(b)

[F31Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern IrelandU.K.

43ZA.—(1) This regulation applies only to licence holders in Great Britain supplying listed NIMAR products to Northern Ireland.

(2) A licence holder must comply with the guidelines on good distribution practice, published under, or that apply by virtue of, regulation C17.

(3) So that the needs of patients in Northern Ireland are met, the licence holder must ensure, within the limits of the holder’s responsibility, the continued supply of listed NIMAR products to—

(a)registered pharmacies in Northern Ireland;

(b)any person who may lawfully sell those products by retail sale or may lawfully supply them in circumstances corresponding to retail sale in Northern Ireland;

(c)any person who may lawfully administer prescription only medicines in Northern Ireland.

(4) The licence holder must provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of listed NIMAR products under the licence as are necessary—

(a)to maintain the quality of the products; and

(b)to ensure their proper distribution.

(5) The licence holder must inform the licensing authority of any proposed structural alteration to, or discontinuance of use of, premises to which the licence relates or which have otherwise been approved by the licensing authority.

(6) The licence holder must not sell or supply, or offer for sale or supply, listed NIMAR products to a person in Northern Ireland, unless—

(a)there is a UKMA(UK) or UKMA(GB) in force in relation to that product; and

(b)the sale or supply is in accordance with that authorisation (except for the fact the product will be in Northern Ireland).

(7) The licence holder must—

(a)keep documents relating to the sale or supply of listed NIMAR products under the licence which may facilitate the withdrawal or recall from sale of such products in accordance with paragraph (b);

(b)maintain an emergency plan to ensure effective implementation of the recall from the market of a listed NIMAR product where recall is—

(i)ordered by the licensing authority or

(ii)carried out in co-operation with the manufacturer of, or the holder of the corresponding UKMA(GB) or UKMA(UK) for the product; and

(c)keep records in relation to the receipt, dispatch or brokering of listed NIMAR products, of—

(i)the date of receipt,

(ii)the date of despatch,

(iii)the date of brokering,

(iv)the name of the listed NIMAR product,

(v)the quantity of the product received, dispatched or brokered,

(vi)the name and address of the person from whom the products were received or to whom they are dispatched; and

(d)provide the records in sub-paragraph (c) to the licensing authority on request.

(8) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority, on production of identification, to carry out any inspection, or to take any samples or copies, which an inspector could carry out or take under Part 16 (enforcement).

(9) The licence holder must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.

(10) The licence holder must immediately inform the licensing authority of medicinal products which the licence holder receives or is offered which the licence holder—

(a)knows or suspects; or

(b)has reasonable grounds for knowing or suspecting,

to be falsified.

(11) Where the listed NIMAR product is obtained through brokering, a licence holder must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b).]

Textual Amendments

[F32Requirement for wholesale dealers to decommission the unique identifierU.K.

43A.—(1) This regulation applies only to medicinal products that are required to bear safety features pursuant to Article 54a of the 2001 Directive.

(2) Before supplying a medicinal product to a person [F33in Northern Ireland] who falls within one of the classes specified in paragraph (3), the licence holder must verify the safety features and decommission the unique identifier of that medicinal product in accordance with the requirements laid down in Commission Regulation 2016/161.

(3) The classes of person mentioned in paragraph (2) are—

(a)persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;

(b)persons who receive the product for the purpose of selling, supplying or administering it as a veterinary medicinal product;

(c)dentists;

(d)registered optometrists or registered dispensing opticians;

(e)registered paramedics;

(f)persons who are members of Her Majesty’s armed forces;

(g)F34... the Police Service of Northern Ireland;

(h)government institutions maintaining stocks of medicinal products for the purposes of civil protection or disaster control;

(i)universities or other institutions concerned with higher education or research, other than healthcare institutions;

(j)a prison service;

(k)persons carrying on the business of a school;

(l)[F35nursing] homes;

(m)hospices.]

Textual Amendments

[F36Requirement for wholesale dealers to deal only with specified personsU.K.

44.—F37(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) [F38The] licence holder must not obtain supplies of medicinal products from anyone except—

(a)the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

(b)the person who holds an authorisation granted by [F39an approved country for import (in the case of a licence holder in Great Britain) or by an EEA State (in the case of a licence holder in Northern Ireland)] authorising the manufacture of products of the description or their distribution by way of wholesale dealing; [F40or]

[F41(c)where the medicinal product is directly received—

(i)in the case of a licence holder in Great Britain, from a country that is not an approved country for import (“A”), for export to a country that is not an approved country for import (“B”), and

(ii)in the case of a licence holder in Northern Ireland, from a country other than an EEA State (“A”) for export to another country other than an EEA State (“B”),

the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A.]

F42(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Where a medicinal product is obtained in accordance with paragraph F43... (2)(a) or (b), the licence holder must verify that—

(a)the wholesale dealer who supplies the product complies with the principles and guidelines of good distribution practices; or

(b)the manufacturer or importer who supplies the product holds a manufacturing authorisation.

F44(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) [F45The] licence holder may distribute medicinal products by way of wholesale dealing only to—

(a)the holder of a wholesale dealer’s licence relating to those products;

[F46(b)the holder of an authorisation granted by—

(i)in the case of a licence holder in Great Britain, the appropriate authority of an approved country for import;

(ii)in the case of a licence holder in Northern Ireland, the competent authority of an EEA State,

that is responsible for authorising the supply of those products by way of wholesale dealing;]

(c)a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale;

(d)a person who may lawfully administer those products; or

[F47(e)in relation to supply—

(i)in the case of a licence holder in Great Britain to persons in countries other than approved countries for import, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country to which the product is supplied;

(ii)in the case of a licence holder in Northern Ireland to persons in a country other than an EEA State, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country other than an EEA State concerned.]

(6) Where a medicinal product is supplied to a person who is authorised or entitled to supply medicinal products to the public in accordance with paragraph F48... (5)(c) or (e), the licence holder must enclose with the product a document stating the—

(a)date on which the supply took place;

(b)name and pharmaceutical form of the product supplied;

(c)quantity of product supplied; [F49and]

(d)name and address of the licence holder; and

(e)batch number of the medicinal products bearing the safety features referred to in point (o) of Article 54 of the 2001 Directive [F50, in the case of a licence holder in Northern Ireland.]

(7) The licence holder must—

(a)keep a record of information supplied in accordance with paragraph (6) for at least five years beginning immediately after the date on which the information is supplied; and

(b)ensure that the record is available to the licensing authority for inspection.]

[F51(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(GB) was granted under the unfettered access route if the product satisfies the definition of qualifying Northern Ireland goods.

(9) Paragraph (2)(c) does not apply to—

(a)in the case of a licence holder in Great Britain, products received from Northern Ireland, and

(b)in the case of a licence holder in Northern Ireland, products received from Great Britain.

(10) Paragraph (5)(e) does not apply to—

(a)in the case of a licence holder in Great Britain, products supplied to Northern Ireland, and

(b)in the case of a licence holder in Northern Ireland, products supplied to Great Britain.]

Textual Amendments

F37Reg. 44(1) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(2) and reg. 44(1) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(2)

F38Word in reg. 44(2) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(a) and word in reg. 44(2) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(a)

F42Reg. 44(2)(d) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(3)(d) and reg. 44(2)(d) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(3)(d)

F43Word in reg. 44(3) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(4) and word in reg. 44(3) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(4)

F44Reg. 44(4) omitted (E.W.S.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(5) and reg. 44(4) omitted (N.I.) (1.10.2015) by virtue of The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(5)

F45Word in reg. 44(5) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 6(6) and word in reg. 44(5) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 6(6)

F48Word in reg. 44(6) omitted (E.W.S.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 7 and word in reg. 44(6) omitted (N.I.) (1.4.2016) by virtue of The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 7

Requirement as to responsible personsU.K.

45.—(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person”) who in the opinion of the licensing authority—

(a)has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and

(b)has adequate experience relating to those activities and procedures.

[F52(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.]

(2) Those functions are—

(a)ensuring that the conditions under which the licence was granted have been, and are being, complied with; and

[F53(b)ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—

(i)in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and

(ii)in the case of a licence holder in Northern Ireland, the marketing authorisations, [F54requirements of regulation 167A,] Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.]

(3) The licence holder must notify the licensing authority of—

(a)any change to the responsible person; and

(b)the name, address, qualifications and experience of the responsible person.

(4) The licence holder must not permit any person to act as a responsible person other than the person named in the licence or another person notified to the licensing authority under paragraph (3).

(5) Paragraph (6) applies if, after giving the licence holder and a person acting as a responsible person the opportunity to make representations (orally or in writing), the licensing authority thinks that the person—

(a)does not satisfy the requirements of paragraph (1) in relation to qualifications or experience; or

(b)is failing to carry out the functions referred to in paragraph (2) adequately or at all.

(6) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a responsible person.

Textual Amendments

[F55Requirement as to responsible persons where licence holder imports from an approved country for importU.K.

45AA.—(1) Subject to paragraph (2), this regulation applies to a licence holder in Great Britain where the licence holder imports a medicinal product from an approved country for import under a wholesale dealer's licence.

(2) The requirements of this regulation do not apply where an unlicensed medicinal product falling under paragraph (1) is imported—

(a)from an approved country for import for the sole purpose of distribution by way of wholesale dealing as a special medicinal product; or

(b)for the sole purpose of wholesale distribution of that product to a person in a country other than an approved country for import.

(3) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person (import)”) whose name is included in the register established under regulation 45AB.

(4) A responsible person (import) must—

(a)carry out the functions under regulation 45(2), unless a responsible person under regulation 45 is performing those functions in respect of the licence; ...

(b)ensure that there is appropriate evidence to confirm that each production batch of a medicine imported from an approved country for import under the licence has been certified as provided for in Article 51 of the 2001 Directive, or such equivalent certification procedure as applies in the approved country for import; and

(c)ensure that each production batch of a medicinal product that is subject to the batch testing condition and that is imported into Great Britain from an approved country for import has been certified as being in conformity with the approved specifications in the UK marketing authorisation by—

(i)the appropriate authority, or

(ii)where the batch testing exemption applies, a laboratory in a country that has an agreement with the United Kingdom to the effect that the appropriate authority will recognise that certificate in place of the appropriate authority’s own examination.

(5) The licensing authority must publish guidance on the documentation that it considers to be appropriate evidence for the purposes of paragraph (4)(b).

(6) Guidance published under paragraph (5) may be taken into account by the licensing authority in determining whether it considers there has been a failure to comply with this regulation.

(7) The licence holder must apply to vary the licence if a change is proposed to the responsible person (import).

(8) The licence holder must not permit any person to act as a responsible person (import) other than the person named in the licence.

(9) Paragraph (10) applies if—

(a)the person acting as responsible person (import) in respect of the licence is no longer included in the register under 45AB;

(b)the licensing authority thinks, after giving the licence holder and a person acting as a responsible person (import) the opportunity to make representations (orally or in writing), that the responsible person (import) is failing to carry out the functions referred to in paragraph (4) adequately or at all.

(10) Where this paragraph applies the licensing authority—

(a)must notify the licence holder in writing that the person is not permitted to act as a responsible person (import) in respect of that licence; and

(b)may, subject to regulation 45AB(3)(b), remove that person's name from the register under regulation 45AB.

(11) In this regulation, “unlicensed medicinal product” means a medicinal product in respect of which—

(a)there is no marketing authorisation, within the meaning of the 2001 Directive, in any EEA State in respect of that product, where the product is imported from an approved country for import that is an EEA State; or

(b)there is no licence or authorisation in respect of that product as regards its sale or supply in the approved country for import, where the product is imported from an approved country for import that is not an EEA State.

Textual Amendments

Register for responsible persons (import)U.K.

45AB.—(1) The licensing authority must maintain a register of persons (“the responsible person (import) register”) who may carry out the role of responsible person (import) under regulation 45AA.

(2) The licensing authority may only include a person's name in the responsible person (import) register if that person—

(a)holds—

(i)a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, or

(ii)such other qualification as the licensing authority is satisfied is equivalent;

(b)is a member of—

(i)the Royal Society of Biology,

(ii)the Royal Pharmaceutical Society,

(iii)the Pharmaceutical Society of Northern Ireland,

(iv)the Royal Society of Chemistry, or

(v)such other body as may be specified by the licensing authority for the purpose of this paragraph; and

(c)has a minimum of 2 years' experience in performing the functions of a responsible person under regulation 45, or in performing such other functions that appear to the licensing authority to be equivalent.

(3) The licensing authority—

(a)may remove a person's name from the responsible person (import) register if it no longer considers that the person satisfies the requirements of paragraph (2); but

(b)it may not exercise that power unless it has given that person the opportunity to make representations to it (orally or in writing).]

Textual Amendments