The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

This section has no associated Explanatory Memorandum

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

I1Sch. 2 para. 33 in force at 31.12.2020 immediately before IP completion day, see reg. 1