PART 3 U.K. 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) U.K.

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 ”.

Commencement Information

I1 Reg. 25 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1