# The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, Regulation 29: Amendment to regulation 40

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

In regulation 40 (grant or refusal of manufacturing authorisation), in paragraph (1)(a)(ii), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.

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Source: https://www.legislation.gov.uk/uksi/2025/538/regulation/29 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.