# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 1

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

(1) Subject to the following sub-paragraphs, where the United Kingdom Ethics Committee Authority (“the Authority”) receive a notice pursuant to regulation 24(3) that a sponsor wishes to appeal against an ethics committee opinion which is not favourable, the Authority shall, subject to sub-paragraph (2)—
(a) direct that the application for that opinion may be considered by another ethics committee specified in the direction; ...
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) ... The Authority may refuse to give a direction ... pursuant to sub-paragraph (1) where it considers that the grounds for appealing against the opinion are unfounded.
(3) Where the Authority refuse to give a direction ... pursuant to sub-paragraph (1), the Authority shall send a notice to the sponsor setting out their reasons for refusal.
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/4/paragraph/1 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-4/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.