The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972

Exemptions in respect of clinical trials and medicinal tests on animals

4.—(1) Subject to paragraph (4) of this Article, the restrictions imposed by sections 7, 31(2) and 32 of the Act (restrictions as to dealings with medicinal products for clinical trials or medicinal tests on animals) shall not apply to anything done in relation to a medicinal product when—

(a) it consists of selling or supplying, or procuring the sale or supply of, medicinal products for the purposes of a clinical trial or, as the case may be, a medicinal test on animals, or

(b) it is done by a person in the course of a business carried on by him and consists of administering a medicinal product to an animal by way of a medicinal test on animals, or procuring such medicinal product to be so administered,

provided the conditions specified in paragraph (2) of this Article are satisfied.

(2) The conditions referred to in the preceding paragraph are—

(i) that either (a) the person selling or supplying the medicinal product is selling or supplying that product exclusively for the purposes of a clinical trial or, as the case may be, for a medicinal test on animals, or (b) where he is not selling or supplying that product exclusively as aforesaid, that in so far as he is selling or supplying the product for other purposes, such sale or supply is in accordance with a product licence, or clinical trial or animal test certificate or in circumstances which enable such sale or supply to be carried out otherwise than in accordance with such licence or certificate,

(ii) that, in relation to medicinal tests on animals, the manufacture or assembly of the medicinal product in question is procured by a veterinary surgeon or a veterinary practitioner for the purpose of its being administered to one or more animals which are under his care,

(iii) that the clinical trial or, as the case may be, medicinal test on animals in question is not to be carried out under arrangements made by or on behalf of the person who manufactured that medicinal product, the person responsible for its composition (within the meaning of section 7(6) of the Act) or the person selling or supplying it unless such person is the doctor or dentist or one of the doctors or dentists, by whom, or under whose direction that medicinal product is to be administered in that trial or, as the case may be, the person by whom or under whose direction that medicinal product is to be administered in that test,

(iv) that the doctor or dentist or one of the doctors or dentists by whom or under whose direction the medicinal product is to be administered in the clinical trial or as the case may be, that the person by whom or under whose direction the medicinal product is to be administered in the medicinal test on animals has notified the licensing authority of the trial, or, as the case may be the test, in question, specifying the product and the use of the product that is to be administered and the name and address of the supplier of that product, and

(v) that the licensing authority has not, within the period of 21 days of the date of such notification, or within such extended period as the licensing authority may in a particular case allow, directed that the provisions of this Article shall not apply to the medicinal product in question.

(3) Without prejudice to the preceding paragraphs of this Article, the restrictions imposed by sections 7(3) and 31(4) of the Act (restrictions as to importation of medicinal products for clinical trials) shall not apply to the importation of a medicinal product, exclusively for the purpose of a clinical trial, provided that the conditions specified in sub-paragraph (ii), (iii), (iv) and (v) of the preceding paragraph are satisfied in relation to the medicinal product and the clinical trial in question.

(4) Paragraph (1) of this Article shall not have effect in relation to a veterinary surgeon or veterinary practitioner where the medicinal test in question is to be carried out under arrangements made by, or at the request of, another person, and (where the arrangements are made by the veterinary surgeon or veterinary practitioner and not at the request of any other person) shall not have effect so as to exempt from the restrictions in question anything done—

(a) in relation to a vaccine specially prepared for administration to poultry, or

(b) in relation to any other vaccine, unless the vaccine is specially prepared for administration to the animal from which it is derived, or

(c) in relation to plasma or a serum, unless the plasma or serum is specially prepared for administration to one or more animals in the herd from which it is derived.