Control of Clinical Trials Act, 1987

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Restriction on application of Act, etc.

2.—(1) (a) The provisions of this Act shall not apply in respect of any clinical trial which is being conducted at the commencement of this Act.

(b) Where any arrangements to undertake or to conduct a clinical trial were or were being made before the commencement of this Act and where paragraph (a) does not apply, then such arrangements shall, for the purpose of an application under section 3 , be treated as if they had not been made otherwise than in accordance with that section.

(2) Where a person proposes to arrange for the conducting of a clinical trial or to conduct a clinical trial and there is in force in respect of the substance or preparation concerned a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984), then the provisions of sections 3 to 11 shall not apply where—

(a) the National Drugs Advisory Board—

(i) have been notified in writing of the proposal, and

(ii) are satisfied with the composition of a committee appointed to consider the justification for conducting the proposed clinical trial and the circumstances under which the proposed trial is to be conducted, and

(iii) have received such information, evidence, documents, samples or other materials that they may have, not later than 4 weeks after being so notified, requested in relation to the proposed clinical trial,

and

(b) the conditions under which the product authorisation was granted are complied with in respect of the substance or preparation concerned.

(3) Where a person proposes to arrange for the conducting of a clinical trial or to conduct a clinical trial, and

(a) there is in force in respect of the substance or preparation concerned a product authorisation granted under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, and

(b) the purpose of the clinical trial is to determine the effect of a new use for the substance or preparation concerned,

then the provisions of sections 3 to 6 and sections 8 to 11 shall not apply where—

(i) the National Drugs Advisory Board have been notified in writing of the proposal and have, not later than 6 weeks after being so notified, made a recommendation to the Minister on the proposal, and

(ii) the Minister has granted permission for the proposed trial to be undertaken, and

(iii) in respect of the substance or preparation concerned, the conditions relating to dosage form contained in the product authorisation so granted are complied with when the clinical trial is being conducted and the dosage administered in each case does not exceed that specified in the said authorisation.