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))

27.  In regulation 37 (insertion of new regulations 45AA and 45AB (responsible persons: import)), in the inserted regulation 45AA— U.K.

(a) in paragraph (1), after “this regulation applies” insert “ to a licence holder in Great Britain ”;

(b) omit “and” at the end of paragraph (4)(a);

(c) at the end of paragraph (4)(b) insert—

“; and

(c) ensure that each production batch of a medicinal product that is subject to the batch testing condition and that is imported into Great Britain from an approved country for import has been certified as being in conformity with the approved specifications in the UK marketing authorisation by—

(i) the appropriate authority, or

(ii) where the batch testing exemption applies, a laboratory in a country that has an agreement with the United Kingdom to the effect that the appropriate authority will recognise that certificate in place of the appropriate authority's own examination.”.

Commencement Information

I1 Sch. 2 para. 27 in force at 31.12.2020 immediately before IP completion day, see reg. 1