The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 15 Amendment of Part 14 (advertising)

Amendment of regulation 279 (products without a marketing authorisation)

211.  In regulation 279—

(a) in sub-paragraph (a), insert “UK” before “marketing authorisation”;

(b) at the end of sub-paragraph (b), insert “or”; and

(c) omit sub-paragraph (d) (and “or” immediately preceding it).

Amendment of regulation 280 (general principles)

212.  In regulation 280(1)—

(a) for “marketing authorisation,” substitute “UK marketing authorisation or”; and

(b) omit “or Article 126a authorisation”.

Amendment of regulation 281 (duties of authorisation holders and registration holders)

213.  In regulation 281(1)—

(a) in sub-paragraph (a), insert “UK” before “marketing authorisation”;

(b) at the end of sub-paragraph (b) insert “or”; and

(c) omit sub-paragraph (d) (and “or” immediately preceding it).

Amendment of regulation 293 (prohibition of supply to the public for promotional purposes)

214.  In regulation 293(1)—

(a) insert “UK” before “marketing authorisation”;

(b) for “certificate of registration,” substitute “certificate of registration or”; and

(c) omit “or Article 126a authorisation”.

Amendment of regulation 295 (abbreviated advertisements)

215.  In regulation 295(2)(d)—

(a) insert “UK” before “marketing authorisation”;

(b) for “certificate of registration,” substitute “certificate of registration or”; and

(c) omit “or Article 126a authorisation”.

Amendment of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply)

216.  In paragraphs 1, 2 and 6 of Schedule 30(1), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation”, substitute “UK marketing authorisation, certificate of registration or traditional herbal registration”.

Amendment of regulation 299 (medical sales representatives)

217.  In regulation 299(3), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation”, substitute “UK marketing authorisation, certificate of registration or traditional herbal registration”.

(1)

Schedule 30 was amended by S.I. 2014/1878.