The Medicines for Human Use (Clinical Trials) Regulations 2004

[F1Licensing authority decisionU.K.

2.—(1) In the case of a decision not to accept a request for authorisation to conduct a clinical trial or an amendment to the clinical trial authorisation, the licensing authority shall, after considering the report of the appropriate committee—

(a)confirm that they have grounds for not accepting the request or amendment; or

(b)accept the request for authorisation or amendment to the clinical trial authorisation, subject to such conditions as the licensing authority may consider appropriate.

(2) In the case of a decision to impose a condition following a request for authorisation to conduct a clinical trial or a notice of amendment to a clinical trial authorisation, the licensing authority shall, after considering the report of the appropriate committee—

(a)confirm their decision; or

(b)remove or alter the condition in question.

(3) In the case of a notice to suspend or terminate a trial, the licensing authority shall, after considering the report of the appropriate committee, confirm or revoke the notice.

(4) The licensing authority shall give notice to the sponsor or investigator of—

(a)the findings and advice of the appropriate committee and the reasons for it;

(b)their decision in accordance with sub-paragraph (1), (2) or (3).]

Textual Amendments