Amendment of regulation 15 of the principal Regulations

9.  In regulation 15 of the principal Regulations (ethics committee opinion), in paragraph (5)—

(a) in sub-paragraph (b), for “paragraph 2” substitute “paragraph 10”;

(b) in sub-paragraph (e), after “investigator’s brochure” insert “ or, where the investigational medicinal product has a marketing authorization and the product is to be used in accordance with the terms of that authorization, the summary of product characteristics relating to that product”; and

(c) in sub-paragraph (h)—

(i) after “include” insert “ minors or”, and

(ii) for “Part 5” substitute “Part 4 or Part 5 respectively”.