The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
Write the words of this act the way you think they should read. Solon shows your change as a redline against the published text and pins it to that exact text, so it can never be applied to wording you did not see.
Change 1
4 Amendment to regulation 3
(1) Regulation 3 (sponsor of a clinical trial) is amended as follows. (2) In paragraphs (4) and (5)— (a) for “request for authorisation”, in both places where it occurs, substitute “request for approval”; (b) for “regulation 17”, in both places where it occurs, substitute “regulation 16”. (3) In paragraph (6)— (a) for “authorised by the licensing authority” substitute “approved”; (b) for “, 19 or 20” substitute “or 18A”; (c) for “substantial amendment” substitute “modification of an important detail as defined in Part 3”; (d) for “authorisation” substitute “approval”; (e) for “regulations 24 to 26” substitute “regulation 22”. (4) In paragraph (7)— (a) in sub-paragraph (a), omit “, except regulation 15”; (b) in sub-paragraph (b), omit “Parts 2 to 4 of”; (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)— (a) in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”; (b) in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.
4 Amendment to regulation 3
(1) Regulation 3 (sponsor of a clinical trial) is amended as follows. (2) In paragraphs (4) and (5)— (a) for “request for authorisation”, in both places where it occurs, substitute “request for approval”; (b) for “regulation 17”, in both places where it occurs, substitute “regulation 16”. (3) In paragraph (6)— (a) for “authorised by the licensing authority” substitute “approved”; (b) for “, 19 or 20” substitute “or 18A”; (c) for “substantial amendment” substitute “modification of an important detail as defined in Part 3”; (d) for “authorisation” substitute “approval”; (e) for “regulations 24 to 26” substitute “regulation 22”. (4) In paragraph (7)— (a) in sub-paragraph (a), omit “, except regulation 15”; (b) in sub-paragraph (b), omit “Parts 2 to 4 of”; (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)— (a) in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”; (b) in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.
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