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 2 U.K. Amendment of Part 3 (amendment of Part 3 (manufacture and distribution of medicinal products and active substances))

30.  In regulation 41 (amendment of regulation 45F (provision of information)), for the inserted sub-paragraph (b) substitute— U.K.

“(b) in the case of a broker in—

(i) Great Britain, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii) Northern Ireland, either—

(aa) the UK marketing authorisation holder, or

(bb) where applicable, the EU marketing authorisation holder,”.

Commencement Information

I1 Sch. 2 para. 30 in force at 31.12.2020 immediately before IP completion day, see reg. 1