# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 23: Reference to the appropriate committee or the Medicines Commission


(1) This regulation applies where—
(a) a sponsor has been notified under regulation 18(2) or 18B(2) that—
(i) the trial is not approved and the grounds for not approving the trial relate to the licensing authority’s decision on the clinical trial authorisation, or
(ii) the trial is approved subject to specified conditions and those conditions relate to the licensing authority’s decision;
(b) the licensing authority has modified a clinical trial approval under regulation 21; or
(c) the sponsor has been notified under regulation 22A(3) or 22C(2) that—
(i) a proposed substantial modification is not approved and the grounds for not approving the modification relate to the licensing authority’s decision, or
(ii) the proposed substantial modification is approved subject to conditions and those conditions relate to the licensing authority’s decision.
(2) Where this regulation applies, the sponsor may, within the period of 28 days beginning with the day on which notice is given or such extended period as the licensing authority may in any particular case allow, give notice in writing to the licensing authority of the sponsor’s wish to make written or oral representations to the appropriate committee.
(3) Schedule 5 has effect to regulate the procedure for reference to the appropriate committee following receipt of a notice in accordance with paragraph (1).

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/23 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-23
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.