PART 14 Amendment of Part 13 (packaging and leaflets)

Amendment of regulation 269 (offences relating to packaging and package leaflets: other persons)

208.—(1) Regulation 269(1) is amended as follows.

(2) In paragraph (1), for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”.

(3) In paragraph (2)(a)—

(a) for “Article 28 or 32 of the Paediatric Regulation” substitute “regulation 50C(4), 50D(8) or 58A(2)(b)”; and

(b) omit “, Article 9 of Commission Regulation 2016/161”.

(1)

Regulation 269 was amended by S.I. 2015/903 and 2019/62.