The Medicines (Exemption from Licences) (Clinical Trials) Order 1995

Conditions

4.—(1) The exemption conferred by article 3 is subject to the conditions that:

(a) the supplier has given or sent to the licensing authority a notice which states his intention to sell or supply, or procure the sale, supply, manufacture or assembly of, medicinal products of the description in question for the purposes of a clinical trial and which is accompanied by—

(i) the particulars and the summaries specified in Schedule 1 to this Order,

(ii) a certificate signed by a doctor which lists his medical and scientific qualifications and which states that he is a medical adviser in the employment of, or a consultant to, the supplier; that he has satisfied himself as to the accuracy of the summaries specified at paragraph 14 of Schedule 1 to this Order; and that, having regard to the contents of those summaries, he is of the opinion that it is reasonable for the proposed clinical trial to be undertaken, and

(iii) a notice containing the information specified in Schedule 2 to this Order;

(b) the licensing authority have not, before the end of the specified period, given or sent to the supplier a notice stating that the provisions of this Order shall not apply to the activities proposed to be carried out by him in relation to the medicinal product; and

(c) the supplier has given an undertaking to the licensing authority that he will inform them forthwith of—

(i) any adverse reactions associated with the administration of the medicinal product that are both serious and unexpected,

(ii) any other matter coming to his attention which might reasonably cause the licensing authority to think that the medicinal product could no longer be regarded as a product which could safely be administered for the purposes of the clinical trial or as a product which was of satisfactory quality for those purposes,

(iii) any change in respect of any matter specified in Schedule 3 to this Order, and

(iv) any refusal to approve the clinical trial by a committee established or recognised by a health authority constituted under the National Health Service Act 1977(1) or, as the case may be, by a Health Board or a Special Health Board constituted under the National Health Service (Scotland) Act 1978(2) or by a Health and Social Services Board constituted under the Health and Personal Social Services (Northern Ireland) Order 1972(3), to advise on the ethics of research investigations on human beings.

(2) In paragraph (1)(b) and article 5(1), “the specified period” means the period of thirty-five days from the date on which the licensing authority gives or sends the supplier notice that they have received the notice referred to in paragraph (1)(a), or such period extended by the licensing authority by not more than twenty-eight days; and if they so extend such period such licensing authority shall give or send to the supplier, within such period of thirty-five days, a notice stating the duration of the extension.

(1)

1977 c. 49. The definition of “health authority” in section 128(1) of that Act was substituted by the Health and Social Security Act 1984 (c. 48), paragraph 11 of Schedule 3. See also section 2 of the National Health Service and Community Care Act 1990 (c. 19).

(2)

1978 c. 29. Section 2, under which Health Boards are constituted, was amended to permit the creation of Special Health Boards by the National Health Service and Community Care Act 1990, section 28.

(3)

S.I. 1972/1265 (N.I. 14).