# The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, Regulation 12: Amendment to regulation 12

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

(1) Regulation 12 (requirement for authorisation and ethics committee opinion) is amended as follows.
(2) In paragraph (2)—
(a) in sub-paragraph (a), for “subject” substitute “participant”;
(b) in sub-paragraph (b), for “subjects” substitute “participants”.
(3) For paragraph (3) substitute—
“(3) The conditions referred to in paragraphs (1) and (2) are—
(a) an ethics committee has given a favourable opinion in relation to the clinical trial; and
(b) the clinical trial has been authorised by the licensing authority,
in accordance with these Regulations.”.
(4) Omit paragraph (4).

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Source: https://www.legislation.gov.uk/uksi/2025/538/regulation/12 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.