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

Reference to the appropriate committee or the Medicines CommissionU.K.

26.—(1) If—

(a)a sponsor has been notified by the licensing authority that—

(i)there are grounds for not accepting a request for authorisation, or

(ii)in accordance with regulation 18(2) or (6), 19(8) or 20(5), the trial is authorised subject to specified conditions;

(b)the licensing authority has amended a clinical trial authorisation under regulation 23; or

(c)the sponsor F1... has been notified by the licensing authority in accordance with regulation [F224(5)] or 25(3) that—

(i)the authority does not accept a proposed, modified or adapted amendment to the clinical trial authorisation, or

(ii)the authority accepts such an amendment subject to conditions,

the sponsor may, within 28 days, or such extended period as the licensing authority may in any particular case allow, of the notice being given, give notice in writing to the licensing authority of his wish to make written or oral representations to the appropriate committee F3....

(2) Schedule 5 shall have effect to regulate the procedure for reference to the appropriate committee F4... following receipt of a notice in accordance with paragraph (1).

Textual Amendments