The Human Medicines Regulations 2012

General requirements U.K.

294.—(1) This regulation applies to an advertisement that—

(a) relates to a medicinal product; and

(b) is wholly or mainly directed at persons qualified to prescribe or supply such products.

(2) A person may not publish an advertisement to which this regulation applies unless—

(a) subject to [F1 paragraphs (2C) and (3),] it contains the particulars set out in paragraphs 1 to 8 of Schedule 30; and

(b) in the case of a written advertisement, it is in accordance with paragraph 9 of that Schedule.

[F2 (2A) By way of an exception to paragraph (2), in the case of an advertisement that relates to a pharmacy medicine or a medicinal product subject to general sale, a person may publish the advertisement if it contains—

(a) the particulars set out in paragraphs 2 to 6 of Schedule 30; and

(b) the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by

(c) a website address that corresponds to that statement.

(2B) The website at the address mentioned in paragraph (2A)(c) must make available—

(a) the particulars set out in paragraphs 1 to 8 of Schedule 30; or

(b) a copy of the summary of the product characteristics.]

[F3 (2C) Paragraph 1 of Schedule 30 does not apply in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174.]

(3) In the case of an advertisement that is not a written advertisement, those particulars may alternatively be made available in written form to all persons to whom the advertisement is made available.

(4) This regulation—

(a) does not apply to an advertisement to which regulation 295 (abbreviated advertisements) applies;

(b) does not apply to oral representations made by medical sales representatives to which regulation 299 (medical sales representatives) applies; and

(c) is subject to regulations 296 (exception for advertisements intended as a reminder) and 301 (advertisements for registered homoeopathic medicinal products).

[F4 (5) In the case of an advertisement which relates to a medicinal product for sale or supply—

(a) in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,

(b) in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and

(c) in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—

(i) the product for sale or supply in Great Britain, and

(ii) the product for sale or supply in Northern Ireland.]

Textual Amendments

F1 Words in reg. 294(2)(a) substituted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 26(2) and words in reg. 294(2)(a) substituted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 26(2)

F2 Reg. 294(2A)(2B) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 24(2) and reg. 294(2A)(2B) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 24(2)

F3 Reg. 294(2C) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 26(3) and reg. 294(2C) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 26(3)

F4 Reg. 294(5) inserted (31.12.20200 by S.I. 2019/775, reg. 214A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 172)