The Human Medicines Regulations 2012

Requirement for authorisation U.K.

46.—(1) A person may not sell or supply, or offer to sell or supply, an unauthorised medicinal product.

(2) A person may not sell or supply, or offer to sell or supply, a medicinal product otherwise than in accordance with the terms of—

(a) a [F1 UK] marketing authorisation;

F2 (aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a certificate of registration;

(c) a traditional herbal registration; or

(d) an Article 126a authorisation.

(3) A person may not possess an unauthorised medicinal product if the person knows or has reasonable cause to believe that the product is intended to be sold or supplied to another person within the [F3 United Kingdom or the] European Economic Area.

(4) A person may not in the circumstances mentioned in paragraph (5)—

(a) manufacture or assemble a medicinal product; or

(b) procure the sale, supply, manufacture or assembly of a medicinal product.

(5) Those circumstances are that the person knows or has reasonable cause to believe that the medicinal product has been or is intended to be sold or supplied contrary to paragraph (1).

(6) For the purposes of this regulation a medicinal product is unauthorised if none of the following is in force for the product [F4 in the country in which the product is intended to be sold or supplied, or offered for sale or supply]—

(a) a [F5 UK] marketing authorisation;

F6 (aa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a certificate of registration;

(c) a traditional herbal registration; or

(d) an Article 126a authorisation.

(7) This regulation is subject to—

(a) Part 10 (exceptions to requirement for marketing authorisation etc); and

(b) Article 83 of Regulation (EC) No 726/2004 (authorisation of placing on the market of medicinal product for compassionate reasons).

(8) A medicinal product is not unauthorised for the purposes of this regulation if—

(a) it is sold or supplied, or offered for sale or supply, for export to an EEA State; and

(b) the product may lawfully be sold or supplied in that state by virtue of legislation adopted by that state in compliance with the 2001 Directive.

(9) Paragraphs (1) and (2) do not apply to the sale, supply, or offer for sale or supply, of a medicinal product to a person outside the [F7 United Kingdom or the] European Economic Area.

(10) Paragraphs (1) and (2) do not apply to the sale, supply, or offer for sale or supply, of an investigational medicinal product to a person specified in regulation 13(1) of the Clinical Trials Regulations for the purposes of administering that product in a clinical trial, provided that the conditions specified in regulation 13(2) of those Regulations are satisfied.

(11) Paragraph (3) does not apply to possession of an investigational medicinal product by a person who knows or has reasonable cause to believe—

(a) that the investigational medicinal product is intended to be sold or supplied within the [F8 United Kingdom or the] European Economic Area; and

(b) that paragraph (10) will apply to the sale or supply.

Textual Amendments

F1 Word in reg. 46(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 46(2)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 24(a)

F3 Words in reg. 46(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(3); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 46(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(4)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in reg. 46(6)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Reg. 46(6)(aa) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 24(b)

F7 Words in reg. 46(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(6); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in reg. 46(11)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(7); 2020 c. 1, Sch. 5 para. 1(1)