The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
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Change 1
43 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
(1) The Medicines (Products for Human Use) (Fees) Regulations 2016 are amended as follows. (2) In regulation 20— (a) in the heading, for “amendments” substitute “modifications”; (b) in paragraph (1)— (i) for “valid notice of amendment under regulation 24 (amendments” substitute “modification request under regulation 22 (modifications”; (ii) for “paragraphs 10 or 11 of Part 2 of Schedule 3 (request for authorisation)” substitute “paragraphs 2 or 5(a) of Part A1 of Schedule 3 (request for approval)”. (3) In Schedule 2, in Part 4, in paragraph 49, for “notice of amendment relating to an amendment” substitute “modification request relating to a modification”.
43 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
(1) The Medicines (Products for Human Use) (Fees) Regulations 2016 are amended as follows. (2) In regulation 20— (a) in the heading, for “amendments” substitute “modifications”; (b) in paragraph (1)— (i) for “valid notice of amendment under regulation 24 (amendments” substitute “modification request under regulation 22 (modifications”; (ii) for “paragraphs 10 or 11 of Part 2 of Schedule 3 (request for authorisation)” substitute “paragraphs 2 or 5(a) of Part A1 of Schedule 3 (request for approval)”. (3) In Schedule 2, in Part 4, in paragraph 49, for “notice of amendment relating to an amendment” substitute “modification request relating to a modification”.
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