The Human Medicines Regulations 2012

General U.K.

Products without a marketing authorisation etc U.K.

[F1 279.— (1) A person may not publish an advertisement in Great Britain for a medicinal product unless one of the following is in force for the product—

(a) a UKMA(GB) or UKMA(UK);

[F2 (aa) an authorisation by the licensing authority on a temporary basis under regulation 174;]

(b) a COR(GB) or COR(UK); or

(c) a THR(GB) or THR(UK).

(2) A person may not publish an advertisement in Northern Ireland for a medicinal product unless one of the following is in force for the product—

(a) a UKMA(NI) or UKMA(UK);

[F3 (aa) an authorisation by the licensing authority on a temporary basis under regulation 174;]

(b) a COR(NI) or COR(UK);

(c) a THR(NI) or THR(UK);

(d) an EU marketing authorisation; or

(e) an Article 126a authorisation.

(3) A person may not publish an advertisement in the whole United Kingdom for a medicinal product unless, in relation to that product—

(a) one of the authorisations or registrations specified in paragraph (1) is in force in Great Britain; and

(b) one of the authorisations or registrations specified in paragraph (2) is in force in Northern Ireland.]

Textual Amendments

F1 Reg. 279 substituted (31.12.2020) by S.I. 2019/775, reg. 211 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 167)

F2 Reg. 279(1)(aa) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 11(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350, regs. 1(3), 11(a)

F3 Reg. 279(2)(aa) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 11(b) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 11(b)

General principles U.K.

280.—(1) A person may not publish an advertisement for a medicinal product with a [F4 UK marketing authorisation, EU marketing authorisation,] traditional herbal registration or Article 126a authorisation unless the advertisement complies with the particulars listed in the summary of the product characteristics.

[F5 (1A) Where an advertisement mentioned in paragraph (1) relates to a product in relation to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or registrations (as the case may be).]

(2) A person may not publish an advertisement for a medicinal product unless the advertisement encourages the rational use of the product by presenting it objectively and without exaggerating its properties.

(3) A person may not publish an advertisement for a medicinal product that is misleading.

[F6 (4) A person may not publish an advertisement for a medicinal product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation [F7 281(1)(a) to (e)]), unless it is published as part of a campaign that has been approved by the Ministers.]

Textual Amendments

F4 Words in reg. 280(1) substituted (31.12.2020) by S.I. 2019/775, reg. 212(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 168(b))

F5 Reg. 280(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 212(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 168(c))

F6 Reg. 280(4) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 18 and reg. 280(4) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 18

F7 Words in reg. 280(4) substituted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 12 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 12

Duties of authorisation holders and registration holders U.K.

281.—(1) This regulation applies to a person who holds—

(a) a [F8 UK] marketing authorisation for a medicinal product;

(b) a certificate of registration for a medicinal product;

(c) a traditional herbal registration for a medicinal product; F9 ...

(d) an Article 126a authorisation for a medicinal product [F10 ; or

(e) an EU marketing authorisation for a medicinal product.]

[F11 (1A) Paragraphs (3) to (5) apply to the holder of a temporary authorisation in relation to a medicinal product.]

(2) The person must establish a scientific service to compile and collate all information relating to the product (whether received from medical sales representatives employed by that person or from any other source).

(3) The person must ensure that any medical sales representative who promotes the product is given sufficient training, and has sufficient scientific knowledge, to enable the representative to provide information about the product that is as precise and complete as possible.

(4) The person must retain—

(a) a sample of any advertisement for which the person is responsible relating to the product; and

(b) a statement indicating the persons to whom the advertisement is addressed, the method of its publication and the date when it was first published.

(5) The person must, if required to do so by notice given to the person by the Ministers, within the period specified in that notice—

(a) provide a copy of the sample and statement mentioned in paragraph (4) to the Ministers;

(b) supply such other information as the Ministers may request for the purposes of their functions under this Part; or

(c) provide such assistance as the Ministers may request for those purposes.

Textual Amendments

F8 Word in reg. 281(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 213(a); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in reg. 281(1)(c) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 213(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 169)

F10 Reg. 281(1)(e) and word inserted (31.12.2020) by S.I. 2019/775, reg. 213(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 169)

F11 Reg. 281(1A) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 19 and reg. 281(1A) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 19