The Medicines for Human Use (Clinical Trials) Regulations 2004

2.  Where a direction is given in accordance with paragraph 1(1)(a)—U.K.

(a)the ethics committee which gave the unfavourable opinion shall—

(i)send the application for that opinion, and

(ii)any additional information provided by the chief investigator,

to the ethics committee specified in the direction; and

(b)that committee shall consider the application in accordance with regulation 15.