Part 5Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

Amendment to regulation 29

regulation 18 + 18.—(1) Regulation 29 (conduct of trial in accordance with clinical trial authorisation etc.) is amended as follows.

(2) In paragraphs (a) and (b)—

regulation 18 2 a + (a)for “amended” substitute “modified”;

regulation 18 2 b + (b)for “regulations 22 to 25” substitute “regulations 20 to 22C”.

(3) In paragraph (c)(1)—

regulation 18 3 a + (a)omit “by the licensing authority”;

regulation 18 3 b + (b)for “regulation 18(2) or (6), 19(8), 20(5), 24(5)” substitute “regulation 18(3), 18B(3), 22A(4), 22C(3)”.