# The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, Regulation 36: Amendment to regulation 58

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

In regulation 58 (detailed guidance), in paragraph (c), for “substantial amendment to the clinical trial authorisation” substitute “substantial modification, as defined in regulation 11 (interpretation of Part 3),”.

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Source: https://www.legislation.gov.uk/uksi/2025/538/regulation/36 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-36
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.