Regulation 13 Amendment to regulation 13I1

United Kingdom As made

(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)^f1—

(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”.

Annotations