The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
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Change 1
12 Amendment to regulation 12
(1) Regulation 12 (requirement for authorisation and ethics committee opinion) is amended as follows. (2) In paragraph (2)— (a) in sub-paragraph (a), for “subject” substitute “participant”; (b) in sub-paragraph (b), for “subjects” substitute “participants”. (3) For paragraph (3) substitute— (3) The conditions referred to in paragraphs (1) and (2) are— (a) an ethics committee has given a favourable opinion in relation to the clinical trial; and (b) the clinical trial has been authorised by the licensing authority, in accordance with these Regulations. . (4) Omit paragraph (4).
12 Amendment to regulation 12
(1) Regulation 12 (requirement for authorisation and ethics committee opinion) is amended as follows. (2) In paragraph (2)— (a) in sub-paragraph (a), for “subject” substitute “participant”; (b) in sub-paragraph (b), for “subjects” substitute “participants”. (3) For paragraph (3) substitute— (3) The conditions referred to in paragraphs (1) and (2) are— (a) an ethics committee has given a favourable opinion in relation to the clinical trial; and (b) the clinical trial has been authorised by the licensing authority, in accordance with these Regulations. . (4) Omit paragraph (4).
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