Paragraph 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.”.”.