OpenLegislation

Regulation 280 General principles

United Kingdom

(1)

A person may not publish an advertisement for a medicinal product with a F1UK marketing authorisation F2..., traditional herbal registration or Article 126a authorisation unless the advertisement complies with the particulars listed in the summary of the product characteristics.

F3(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to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or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.

F4(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 F5281(1)(a) to (e)), unless it is published as part of a campaign that has been approved by the Ministers.

Annotations

Textual amendments

F1

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))

F2

Words in reg. 280(1) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 122

F3

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))

F4

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

F5

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