The Human Medicines Regulations 2012

Special provisions for pharmacies etc U.K.

4.—(1) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) do not apply where any provision of section 10 of the Medicines Act 1968 M1 so provides.

(2) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product, except to the extent set out in paragraph (6), but the requirements of paragraph (5) shall apply.

(3) This paragraph applies in a case where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968.

(4) This paragraph applies in the case of a medicinal product where—

(a) the product is the result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

(b) regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

(c) the process of assembly results in a change in the presentation of the authorised medicinal product; and

(d) by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—

(i) the [F1 UK] marketing authorisation,

[F2 (ia) the EU marketing authorisation,]

(ii) the certificate of registration,

(iii) the traditional herbal registration, or

(iv) the Article 126a authorisation,

that relates to the authorised medicinal product.

(5) The information specified in Part 2 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product.

(6) Regulations [F3 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)] and 271 (offences: penalties) shall have effect in relation to paragraph (5) as if that paragraph were a requirement of Part 13.

Textual Amendments

F1 Word in reg. 4(4)(d)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 6(a)(i) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 3); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 4(4)(d)(ia) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 6(a)(ii) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 3); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 4(6) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 6(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 3); 2020 c. 1, Sch. 5 para. 1(1)

Marginal Citations

M1 Section 10(1) was amended by paragraph 10(a) of Part 1 of Schedule 8 to S.I. 2006/2407, paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001, and article 3 of S.I. 1971/1445. Section 10(2) was repealed by paragraph 10(b) and (3)(b) was repealed by paragraph 10(c) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(4) was amended and section 10(5) and (6) inserted by article 3 of S.I. 1971/1445. Section 10(6A) was repealed by paragraph 10(d) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(7) was inserted by article 3 of S.I. 1971/1445, and amended by regulation 3 of S.I. 1993/834. Section 10(7A) to (7C) was inserted by the Health Act 2006 section 26(1), and section 10(7A) was amended by paragraph 10(e) of Part 1 of Schedule 8 to S.I. 2006/2407. Section 10(8) was inserted by S.I. 1971/1445 article 3. Section 10(9) was inserted by paragraph 5(a) of Schedule 3 to the Regulation of Care (Scotland) Act 2001.