The Medicines for Human Use (Clinical Trials) Regulations 2004

4.—(1) An appeal panel shall consider an ethics committee opinion referred to it in accordance with the following sub-paragraphs. U.K.

(2) The appeal panel shall consider—

(a) the opinion;

(b) the application for that opinion;

(c) the particulars and documents accompanying that application;

(d) the matters specified in regulation 15 [F1 (5)];

(e) any representations set out in the notice to the Authority; and

(f) in a case where the opinion has been confirmed by the Gene Therapy Advisory Committee F2 ... pursuant to regulation 16 [F3 (6)], the reasons given by the Committee for that confirmation.

(3) The panel may, if the chief investigator so requests, hold a hearing to consider the opinion, at which the chief investigator may make oral representations.

(4) The panel shall within 30 days of the opinion being referred to the panel, or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion.

Textual Amendments

F1 Word in Sch. 4 para. 4(2)(d) substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 30(b)(i)

F2 Words in Sch. 4 para. 4(2)(f) omitted (29.8.2006) by virtue of The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 30(b)(ii)(aa)

F3 Word in Sch. 4 para. 4(2)(f) substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 30(b)(ii)(bb)