The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

PART 3 Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)

Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products)

25.—(1) Regulation 33 is amended as follows.

(2) In paragraph (1)(a)—

(a) for “Article 15(1) of Regulation 1394/2007” substitute “paragraph 8 of Schedule 6”; and

(b) for “Article 15(4) of that Regulation” substitute “paragraph 9 of that Schedule”.

(3) In paragraph (1)(b), for “Article 15(1)” substitute “paragraph 8”.

(4) In paragraph (2) for “Article 15(4)” substitute “paragraph 9”.