Medicines Act 1968

31 Clinical trials. U.K.

(1) In this Act “clinical trial” means an investigation or series of investigations consisting of the administration of one or more medicinal products of a particular description—

(a) by, or under the direction of, a doctor or dentist to one or more patients of his, or

(b) by, or under the direction of, two or more doctors or dentists, each product being administered by, or under the direction of, one or other of those doctors or dentists to one or more patients of his,

where (in any such case) there is evidence that medicinal products of that description have effects which may be beneficial to the patient or patients in question and the administration of the product or products is for the purpose of ascertaining whether, or to what extent, the product has, or the products have, those or any other effects, whether beneficial or harmful.

(2) Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him,—

(a) sell or supply any medicinal product for the purposes of a clinical trial, or

(b) procure the sale or supply of any medicinal product for the purposes of a clinical trial, or

(c) procure the manufacture or assembly of any medicinal product for sale or supply for the purposes of a clinical trial,

unless one or other of the conditions specified in the next following subsection is fulfilled.

(3) Those conditions, in relation to a person doing any of the things specified in the preceding subsection, are—

(a) that he is the holder of a product licence which authorises the clinical trial in question, or does it to the order of the holder of such a licence, and (in either case) he does it in accordance with that licence;

(b) that a certificate for the purposes of this section (in this Act referred to as a “clinical trial certificate") has been issued certifying that, subject to the provisions of the certificate, the licensing authority have consented to the clinical trial in question and that certificate is for the time being in force and the trial is to be carried out in accordance with that certificate.

(4) Subject to the following provisions of this Act, no person shall import any medicinal product for the purposes of a clinical trial unless either—

(a) he is the holder of a product licence which authorises that clinical trial or imports the product to the order of the holder of such a licence, and (in either case) he imports it in accordance with that licence, or

(b) a clinical trial certificate has been issued certifying as mentioned in subsection (3)(b) of this section and that certificate is for the time being in force and the trial is to be carried out in accordance with that certificate.

(5) Subject to the next following subsection, the restrictions imposed by the preceding provisions of this section do not apply to a doctor or dentist in respect of his selling or supplying, or procuring the sale or supply of, a medicinal product, or procuring the manufacture or assembly of a medicinal product specially prepared to his order, or specially importing a medicinal product, where (in any such case) he is, or acts at the request of, the doctor or dentist by whom, or under whose direction, the product is to be administered.

(6) The exemptions conferred by the last preceding subsection do not apply in a case where the clinical trial in question is to be carried out under arrangements made by, or at the request of, a third party (that is to say, a person who is not the doctor or dentist, or one of the doctors or dentists, by whom, or under whose direction, one or more medicinal products are to be administered in that trial).

(7) The restrictions imposed by subsection (2) of this section do not apply to anything which is done in a registered pharmacy, a hospital or a health centre and is done there by or under the supervision of a pharmacist in accordance with a prescription given by a doctor or dentist; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a doctor or dentist, or of procuring the assembly of a medicinal product.

(8) The restrictions imposed by subsection (2) of this section also do not apply to anything done in relation to a medicinal product where—

(a) it is done by the person who, in the course of a business carried on by him, has manufactured or assembled the product, where he has manufactured or assembled it to the order of a doctor or dentist who has stated that it is required for administration to a patient of his or is required, at the request of another doctor or dentist, for administration to a patient of that other doctor or dentist, or

(b) it is done by the person who, in the course of a business carried on by him, has manufactured or assembled the product to the order of a pharmacist in accordance with a prescription given by a practitioner, or

(c) consists of selling the product by way of wholesale dealing where it has been manufactured or assembled in the circumstances specified in paragraph (a) or paragraph (b) of this subsection.

(9) For the purposes of this section a product licence shall be taken to be a licence which authorises a particular clinical trial if—

(a) the trial is to be a trial of medicinal products of a description to which the licence relates, and

(b) the uses of medicinal products of that description which are referred to in the licence are such as to include their use for the purposes of that trial.

(10) A clinical trial certificate may certify as mentioned in subsection (3)(b) of this section without specifying the doctor or dentist (or, if there is to be more than one, any of the doctors or dentists) by whom, or under whose direction, any medicinal product is to be administered, or the patient or patients to whom any medicinal product is to be administered.

Modifications etc. (not altering text)

C1 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2 S. 31(2) restricted (8.12.1995) by S.I. 1995/2809, art. 2

S. 31 amended (E.W.S.) (prosp.) by 1954 c. 61, s. 13I(1)(b), (as inserted (prosp.) by 1997 c. 19, ss. 1, 2, Sch. para.2)