Point in time view as at 06/11/2023.
The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 4 is up to date with all changes known to be in force on or before 04 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
[F14.—(1) Subject to sub-paragraph (2), the applicant or holder to whom notice is given under paragraph 2 may, within the time allowed after the notification was given—U.K.
(a)notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision; or
(b)make representations in writing to the licensing authority with respect to the decision referred to in the notice.
(2) If the applicant or holder to whom notice is given under paragraph 2 makes written representations in accordance with sub-paragraph (1)(b), the licensing authority shall take those representations into account before deciding whether to—
(a)grant the authorisation,
(b)revoke, vary or suspend the authorisation, or
(c)confirm or alter their decision,
as the case may be.]
Textual Amendments
F1Sch. 8 paras. 4, 5 substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 3 para. 6
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