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

Amendment to regulation 13

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)—

regulation 13 3 a + (a)in sub-paragraph (aa), for “Article 13 of the Directive” substitute “Article 62 of the EU Regulation”;

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