# The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, Regulation 43: Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

Extent: E+W+S+N.I.

(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”.

---
Source: https://www.legislation.gov.uk/uksi/2025/538/regulation/43 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-43
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.