Control of Clinical Trials Act, 1987
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Grant of, or refusal to grant, permission to undertake clinical trial. |
4.—(1) Where in relation to a proposal to arrange for the conducting of a clinical trial— | |
(a) an application has been made in accordance with section 3 (1), and | ||
(b) any request made under section 3 (2) has been complied with, | ||
then, the Minister, after consultation with the National Drugs Advisory Board, shall, not later than 12 weeks after the application has been so made or such request has been so complied with (whichever is the later)— | ||
(i) grant permission for the proposed clinical trial to be undertaken in accordance with the application, or | ||
(ii) grant permission for the proposed clinical trial to be undertaken in accordance with the application subject to such modifications or conditions as he may specify, or | ||
(iii) refuse to grant permission for the proposed clinical trial to be undertaken. | ||
(2) (a) Where under subsection (1) the Minister grants permission for a proposed clinical trial to be undertaken (with or without modifications or conditions), then the trial shall not be conducted until the ethics committee for the trial has given its approval in accordance with section 8 (2). | ||
(b) Where under subsection (1) the Minister refuses to grant permission for the proposed clinical trial to be undertaken, then the Minister shall, when so refusing, inform the applicant of the grounds for such refusal. |