The Human Medicines Regulations 2012

[F1 Wholesale dealing in medicinal products U.K.

18.— (1) A person may not except in accordance with a licence (a “wholesale dealer’s licence”)—

(a) distribute a medicinal product by way of wholesale dealing; F2 ...

(b) possess a medicinal product for the purpose of such [F3 distribution; F4 ...]

[F5 (c) import a medicinal product into Great Britain from an approved country for import] [F6 ; or

(d) supply a listed NIMAR product from Great Britain to Northern Ireland.]

(2) Paragraph (1)—

(a) does not apply—

(i) to anything done in relation to a medicinal product by the holder of a manufacturer’s licence in respect of that product,

(ii) where the product concerned is an investigational medicinal product, or

(iii) if the product is a radiopharmaceutical in which the radionuclide is in the form of a sealed source; and

(b) is subject to regulation 19.

[F7 (2A) Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(2B) For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.]

(3) Distribution of a medicinal product by way of wholesale dealing, or possession for the purpose of such distribution, is not to be taken to be in accordance with a wholesale dealer’s licence unless the distribution is carried on, or as the case may be the product held, at premises located in the UK and specified in the licence.

(4) In these Regulations a reference to distributing a product [F8 (including a listed NIMAR product)] by way of wholesale dealing is a reference to—

(a) selling or supplying it; or

(b) procuring or holding it or exporting it for the purposes of sale or supply,

to a person who receives it for a purpose within paragraph (5).

(5) Those purposes are—

(a) selling or supplying the product; or

(b) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

[F9 (6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—

(a) in the case of a product for sale or supply in Great Britain, a UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration is in force in respect of the product, F10 ...

(b) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration is in force in respect of the product, [F11 or

(c) in the case of a listed NIMAR product, a UKMA(GB) or UKMA(UK) is in force in respect of the product,]

but this is subject to the exceptions in regulation 43(6).]

(7) In [F12 paragraph (6)(b)], “marketing authorisation” means—

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

(b) an EU marketing authorisation.]

Textual Amendments

F1 Reg. 18 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 5

F2 Word in reg. 18(1)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 18(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in reg. 18(1)(b) omitted (1.1.2022) by virtue of The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(a)(i)

F5 Reg. 18(1)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2)(c) (as amended S.I. 2020/1488, reg. 1, Sch. 2 para. 10(a)(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Reg. 18(1)(d) and word inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(a)(ii)

F7 Reg. 18(2A)(2B) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(2A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 10(b)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in reg. 18(4) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(b)

F9 Reg. 18(6) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(3) (as substituted by (S.I. 2020/1488, reg. 1, Sch. 2 para. 10(c)); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in reg. 18(6)(a) omitted (1.1.2022) by virtue of The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(c)(i)

F11 Reg. 18(6)(c) and word inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 5(c)(ii)

F12 Words in reg. 18(7) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 15(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 10(d)); 2020 c. 1, Sch. 5 para. 1(1)