Part 4Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

Amendment to regulation 13

13.—(1) Regulation 13 (supply of investigational medicinal products for the purpose of clinical trials) is amended as follows.

(2) In paragraph (1)(d), for “subject” substitute “participant”.

(3) In paragraph (2)(b)(ii)(1)—

(a)in sub-paragraph (aa), for “Article 13 of the Directive” substitute “Article 62 of the EU Regulation”;

(b)in sub-paragraph (bb), for “Article 13(3) and (4) of the Directive” substitute “Article 62 of the EU Regulation”.