Request for authorisation to conduct a clinical trialU.K.
17.—(1) A request for authorisation to conduct a clinical trial shall be made to the licensing authority by the sponsor of the trial.
(2) A request shall—
(a)be in writing and signed by or on behalf of the sponsor; and
(b)be accompanied by—
(i)the particulars and documents specified in Part 2 of Schedule 3, and
(ii)any fee which may be payable in connection with that application under the Medicines (Products for Human Use—Fees) Regulations 1995 F1.
(3) The request and any accompanying material shall be supplied in the English language.
Textual Amendments