# The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, Regulation 21: Amendment to regulation 31

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

(1) Regulation 31 (suspension or termination of clinical trial) is amended as follows.
(2) In paragraph (1)—
(a) after “clinical trial” insert “or part of a clinical trial”;
(b) in sub-paragraph (a)(ii)—
(i) omit “by the licensing authority”;
(ii) for “regulation 18(2) or (6), 19(8), 20(5), 24(5)” substitute “regulation 18(3), 18B(3), 22A(4), 22C(3)”;
(c) in the words after sub-paragraph (a)(ii), for “site); or” substitute “location);”;
(d) in sub-paragraph (b), for “site,” substitute “location; or”;
(e) after sub-paragraph (b), insert—
(c) the trial has lapsed in accordance with regulation 26 and the sponsor has not notified the licensing authority that the trial has ended,
.
(3) In paragraph (2), for “trial site”, in each place where it occurs, substitute “trial location”.
(4) In paragraph (3)—
(a) in sub-paragraph (a), for “sites” substitute “locations”;
(b) in sub-paragraph (b), after “the trial” insert “in whole or in part, and, if it applies to part of the trial, to which part it applies”;
(c) in sub-paragraph (c)(ii), for “site” substitute “location”.
(5) In paragraph (5)—
(a) for “site”, in both places where it occurs, substitute “location”;
(b) in sub-paragraph (a), after “terminating the trial” insert “(in whole or in part)”.
(6) In paragraph (6), for “subjects” substitute “participants”.

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Source: https://www.legislation.gov.uk/uksi/2025/538/regulation/21 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-21/enacted
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.