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

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

This section has no associated Explanatory Memorandum

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

I1Reg. 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