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 3 U.K. Amendment of Part 4 (amendment of Part 4 (requirement for authorisation))

33.  In regulation 45 (amendment of regulation 46 (requirement for authorisation))— U.K.

(a) for paragraph (2)(b) and (c) substitute—

“(b) after sub-paragraph (a) insert—

“(aa) an EU marketing authorisation;”.”;

(b) for paragraphs (4)(a) to (c) substitute—

“(a) after “in force for the product” insert “ in the country in which the product is intended to be sold or supplied, or offered for sale or supply ”;

(b) in sub-paragraph (a), before “marketing authorisation”, insert “ UK ”; and

(c) after sub-paragraph (a) insert—

“(aa) an EU marketing authorisation;”.”;

(c) omit paragraph (5).

Commencement Information

I1 Sch. 2 para. 33 in force at 31.12.2020 immediately before IP completion day, see reg. 1

34.  In regulation 46 (amendment of regulation 47 (breach of requirement)), omit paragraph (3). U.K.

Commencement Information

I2 Sch. 2 para. 34 in force at 31.12.2020 immediately before IP completion day, see reg. 1