Regulation 297 Written material accompanying promotions

United Kingdom

(1)

A person may not as part of the promotion of a medicinal product send or deliver any written material to a person qualified to prescribe or supply medicinal products unless the material—

(a)

F1subject to paragraph (1A), contains particulars in accordance with all the paragraphs of Schedule 30; and

(b)

states the date on which it was drawn up or last revised.

F2(1A)

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.

(2)

A person may not include any information in written material to which paragraph (1) applies unless it—

(a)

is accurate;

(b)

is up-to-date;

(c)

can be verified; and

(d)

is sufficiently complete to enable the recipient to form an opinion of the therapeutic value of the product to which it relates.

(3)

A person may not include any illustrative material in written material to which paragraph (1) applies unless—

(a)

the illustrative material is accurately reproduced; and

(b)

the written material indicates the precise source of the illustrative material.

(4)

In this regulation “illustrative material” means a quotation, table or any other illustrative material taken from a medical journal or other scientific work.

Annotations

Textual amendments

F1: Words in reg. 297(1)(a) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 28(2) and words in reg. 297(1)(a) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 28(2)
F2: Reg. 297(1A) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 28(3) and reg. 297(1A) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 28(3)