The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
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Change 1
40 Amendment to Schedule 4
(1) Schedule 4 (appeal against unfavourable ethics committee opinion) is amended as follows. (2) In paragraph 1— (a) in sub-paragraph (1)— (i) for “regulation 16(3), 4(b) or (7)” substitute “regulation 24(3)”; (ii) for “chief investigator” substitute “sponsor”; (iii) omit paragraph (b) and the “or” preceding it; (b) in sub-paragraph (2) omit— (i) “Subject to sub-paragraph (4),”; (ii) “or appoint a panel”; (c) in sub-paragraph (3)— (i) omit “or appoint a panel”; (ii) for “chief investigator” substitute “sponsor”; (d) omit sub-paragraph (4). (3) In paragraph 2— (a) in sub-paragraph (a)— (i) for “ethics committee which gave the unfavourable opinion” substitute “Authority”; (ii) for “chief investigator” substitute “sponsor”; (iii) at the end, omit “and”; (b) in sub-paragraph (b), for “regulation 15,” substitute “regulation 17; and”; (c) after sub-paragraph (b), insert— (c) that committee shall within 30 days beginning with the day on which the application is sent to the committee under paragraph (a), or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion. . (4) Omit paragraphs 3 to 6.
40 Amendment to Schedule 4
(1) Schedule 4 (appeal against unfavourable ethics committee opinion) is amended as follows. (2) In paragraph 1— (a) in sub-paragraph (1)— (i) for “regulation 16(3), 4(b) or (7)” substitute “regulation 24(3)”; (ii) for “chief investigator” substitute “sponsor”; (iii) omit paragraph (b) and the “or” preceding it; (b) in sub-paragraph (2) omit— (i) “Subject to sub-paragraph (4),”; (ii) “or appoint a panel”; (c) in sub-paragraph (3)— (i) omit “or appoint a panel”; (ii) for “chief investigator” substitute “sponsor”; (d) omit sub-paragraph (4). (3) In paragraph 2— (a) in sub-paragraph (a)— (i) for “ethics committee which gave the unfavourable opinion” substitute “Authority”; (ii) for “chief investigator” substitute “sponsor”; (iii) at the end, omit “and”; (b) in sub-paragraph (b), for “regulation 15,” substitute “regulation 17; and”; (c) after sub-paragraph (b), insert— (c) that committee shall within 30 days beginning with the day on which the application is sent to the committee under paragraph (a), or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion. . (4) Omit paragraphs 3 to 6.
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