Part 2Amendment to Part 1 (Introductory Provisions)

Amendment to regulation 3

regulation 4 + 4.—(1) Regulation 3 (sponsor of a clinical trial) is amended as follows.

(2) In paragraphs (4) and (5)—

regulation 4 2 a + (a)for “request for authorisation”, in both places where it occurs, substitute “request for approval”;

regulation 4 2 b + (b)for “regulation 17”, in both places where it occurs, substitute “regulation 16”.

(3) In paragraph (6)—

regulation 4 3 a + (a)for “authorised by the licensing authority” substitute “approved”;

regulation 4 3 b + (b)for “, 19 or 20” substitute “or 18A”;

regulation 4 3 c + (c)for “substantial amendment” substitute “modification of an important detail as defined in Part 3”;

regulation 4 3 d + (d)for “authorisation” substitute “approval”;

regulation 4 3 e + (e)for “regulations 24 to 26” substitute “regulation 22”.

(4) In paragraph (7)—

regulation 4 4 a + (a)in sub-paragraph (a), omit “, except regulation 15”;

regulation 4 4 b + (b)in sub-paragraph (b), omit “Parts 2 to 4 of”;

regulation 4 4 c + (c)in sub-paragraph (c), omit “, in so far as it relates to decisions of the licensing authority under Part 3”.

(5) In paragraph (10)—

regulation 4 5 a + (a)in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”;

regulation 4 5 b + (b)in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.