The Human Medicines Regulations 2012

Exemptions from requirement for wholesale dealer's licence U.K.

19.—(1) Regulation 18 does not apply to the sale or offer for sale of a medicinal product by way of wholesale dealing, or possession for the purpose of such sale or offer, where paragraph (2) applies and the person selling or offering the product for sale is—

[F1 (a) the holder of—

(i) in the case of a product for sale or supply in Great Britain [F2 (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)], a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”) which relates to the product, or

(ii) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”) which relates to the product,

including a holder of an authorisation who manufactured or assembled the product; or]

(b) a person who is not the holder of an authorisation in relation to the product but manufactured or assembled the product [F3 in the United Kingdom] to the order of a person who is the holder of an authorisation relating to the product.

(2) This paragraph applies if—

(a) until the sale, the medicinal product has been kept on the premises of the person who manufactured or assembled the product (in this regulation referred to as “authorised premises”); and

(b) those premises are premises authorised for use for manufacture or assembly by that person's manufacturer's licence.

(3) For the purposes of this regulation, a medicinal product is regarded as having been kept on authorised premises at a time when—

(a) it was being moved from one set of authorised premises to another, or from one part of authorised premises to another part; or

(b) it was being moved from authorised premises by way of delivery to a purchaser.

(4) Regulation 18 does not apply to a person who in connection with the importation of a medicinal product—

(a) provides facilities solely for transporting the product; or

(b) acting as an import agent, handles the product where the product is imported solely to the order of another person who intends to sell the product or offer it for sale by way of wholesale dealing or to distribute it in any other way.

[F4 (4A) Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be used for vaccination or immunisation against coronavirus or influenza virus, where the person distributing the medicinal product—

(a) was supplied with the medicinal product for the purposes of the administration of it under relevant arrangements;

(b) is supplying the medicinal product for the purposes of the administration of it by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements; and

(c) is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements.

(4B) Regulation 18 does not apply in connection with the distribution by way of wholesale dealing of a medicinal product to be supplied or administered in accordance with a protocol of the type mentioned in regulation 247, where the person distributing the medicinal product—

(a) was supplied with the medicinal product for the purposes of the supply or administration of it to a patient under relevant arrangements;

(b) is supplying the medicinal product for the purposes of the supply or administration of it to a patient by the person to whom it is being supplied (or by a person employed or engaged by them) under relevant arrangements; and

(c) is authorised by the body making the arrangements to supply the medicinal product as mentioned in sub-paragraph (b) under the relevant arrangements.

(4C) In this regulation, “relevant arrangements” means—

(a) arrangements for the provision of services as part of—

(i) in England, the health service as defined by section 275(1) of the National Health Service Act 2006,

(ii) in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978,

(iii) in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006, and

(iv) in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009; or

(b) arrangements for the provision of services (otherwise than as mentioned in sub-paragraph (a)) as part of the medical services of Her Majesty’s Forces.

(4D) Paragraphs (4A) to (4C) cease to have effect on 1st April [F5 2026].]

F6 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7 (6) Regulation 18 does not apply to a person (“P”) who imports a medicinal product into Great Britain from an approved country for import for administration to P or to any other person who is a member of P’s household.]

Textual Amendments

F1 Reg. 19(1)(a) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 17(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 11(a))

F2 Words in reg. 19(1)(a)(i) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 6

F3 Words in reg. 19(1)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 17(3); 2020 c. 1, Sch. 5 para. 1(1)

F4 Reg. 19(4A)-(4D) inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 4 and reg. 19(4A)-(4D) inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 4

F5 Word in reg. 19(4D) substituted (E.W.S.) (31.3.2024) by The Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024 (S.I. 2024/344), regs. 1(2), 4 and (N.I.) (31.3.2024) by The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024 (S.R. 2024/68), regs. 1(2), 4

F6 Reg. 19(5) omitted (20.8.2013) by virtue of The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 6

F7 Reg. 19(6) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 17(4) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 11(b))