The Human Medicines Regulations 2012

Scope of these Regulations: special provisions U.K.

3.—(1) Regulation 17(1) (manufacturing of medicinal products: requirement for licence) shall not apply in circumstances where paragraph (4) applies.

(2) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) shall not apply in circumstances where paragraph (5) or (6) applies.

(3) These Regulations do not apply where paragraph (7) applies.

(4) This paragraph applies where a medicinal product is assembled by a registered nurse or a registered midwife if—

(a) the nurse or midwife is acting in the course of his or her profession; and

(b) the conditions in paragraphs (8) and (9) are met.

(5) This paragraph applies where a medicinal product is manufactured or assembled by a doctor or dentist and the conditions in paragraphs (8) and (9) are met.

(6) This paragraph applies where a herbal medicinal product is manufactured or assembled by a person (“A”) if—

(a) the manufacture or assembly takes place on premises occupied by A and from which A can exclude the public;

(b) the product is for administration to a person (“B”) and A has been requested by or on behalf of B, and in B's presence, to use A's judgment as to the treatment required;

(c) the product does not contain a substance specified in Part 1 of Schedule 20;

(d) the product does not contain a substance listed in Part 2 of that Schedule, unless the product is sold or supplied—

(i) in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in column 2 of that Part, or

(ii) in the case of a product for external use only, with a percentage of the substance in the product that does not exceed the percentage specified in column 3 of that Part; and

(e) the condition in paragraph (9) is met.

(7) This paragraph applies where the product is a radionuclide that is in the form of a sealed source.

(8) This condition is that the medicinal product is supplied—

(a) to a patient in the course of the treatment of that patient; or

(b) in a case to which paragraph (5) applies, to a patient of another doctor or dentist who is a member of the same medical or dental practice.

(9) This condition is that the medicinal product is not manufactured or, as the case may be, assembled—

(a) on a large scale; or

(b) by an industrial process.

(10) 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 (11) or (12) applies in relation to the product, except to the extent set out in paragraph (14), but the requirements of paragraph (13) shall apply.

(11) This paragraph applies where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of paragraph (5) or (6).

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

(a) the product is the result of a process of assembly of an authorised medicinal product;

(b) regulation 17(1) does not apply to the process of assembly by virtue of paragraph (4) or (5);

(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.

(13) The information specified in Part 1 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—

(a) where paragraph (11) applies to the product, except in the case of a product manufactured in accordance with paragraph (6); or

(b) where paragraph (12) applies in relation to the product.

(14) Regulations 269 (offences relating to packaging and package leaflets: other persons) and 271 (offences: penalties) shall have effect in relation to paragraph (13) as if that paragraph were a requirement of Part 13.

(15) For the purposes of this regulation and regulation 4 (special provisions for pharmacies etc), a medicinal product is authorised if there is in force for the product—

(a) a [F3 UK] marketing authorisation;

[F4 (aa) an EU marketing authorisation;]

(b) a certificate of registration;

(c) a traditional herbal registration; or

(d) an Article 126a authorisation.

Textual Amendments

F1 Word in reg. 3(12)(d)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 5(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 3(12)(d)(ia) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 5(2)(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 2(a)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in reg. 3(15)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 5(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Reg. 3(15)(aa) inserted (3.8.2021) by The Human Medicines (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/834), regs. 1(2), 2