Regulation 279 Products without a marketing authorisation etcF1

United Kingdom

(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);

(F2aa)

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);

(F3aa)

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); F4or

F5(d)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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.

Annotations

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)
F4: Word in reg. 279(2)(c) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 121(a)
F5: Reg. 279(2)(d) 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), 121(b)