[F1Advice in relation to intended clinical investigationsN.I.
17A.—(1) A manufacturer or sponsor may request a meeting with the Secretary of State in advance of an application being submitted under Article 70(1) in order to—
(a)obtain advice on regulatory requirements relating to an intended clinical investigation; or
(b)obtain a statistical review in relation to an intended clinical investigation.
(2) A person who requests a meeting with the Secretary of State under paragraph (1), must pay the following fees in advance of that meeting—
(a)£906 for a regulatory advice meeting under paragraph (1)(a); and
(b)£782 for a statistical review meeting under paragraph (1)(b).
(3) In this regulation, “statistical review” means a review of the statistical sections of the application which a sponsor intends to submit to the Secretary of State under Article 70(1) in respect of an intended clinical investigation.]
Textual Amendments