The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

PART 3 U.K. AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

Amendments to clinical trial authorisation U.K.

22.  Subject to regulation 30, an amendment to a clinical trial authorisation may be made—

(a) by the licensing authority, in accordance with regulation 23; or

(b) by the sponsor, in accordance with regulation 24 or 25.