The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

SCHEDULE 2 U.K. Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 13 U.K. Amendment of Part 14 (amendment of Part 13 (packaging and leaflets))

157.  In regulation 203 (amendment of regulation 260 (package leaflets))— U.K.

(a) in paragraph (2), in the inserted paragraph (1A), after the first reference to “advanced therapy medicinal product” insert “ for sale or supply in Great Britain only ”;

(b) in paragraph (3), in the inserted text, after “advanced therapy medicinal product,” insert “ for sale or supply in Great Britain only ”;

(c) in paragraph (4)—

(i) omit “, Article 126a authorisation”;

(ii) after “UK marketing authorisation” insert “ , EU marketing authorisation, ”.

Commencement Information

I1 Sch. 2 para. 157 in force at 31.12.2020 immediately before IP completion day, see reg. 1