The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

SCHEDULE 2 Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 14 Amendment of Part 15 (amendment of Part 14 (advertising))

167.  For regulation 211 (amendment of regulation 279 (products without a marketing authorisation)) substitute—

“211.   For regulation 279 substitute—

“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);

(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);

(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.”.”.