Part II Licences and Certificates Relating to Medicinal Products
Clinical trials and medicinal tests on animals
C2C332 Medicinal tests on animals. C1
1
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 medicinal test on animals, or
b
procure the sale or supply of any medicinal product for the purposes of such a test, or
c
procure the manufacture or assembly of any medicinal product for sale or supply for the purposes of such a test,
unless one or other of the conditions specified in the next following subsection is fulfilled.
2
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 test in question, or he 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 an “animal test certificate") has been issued certifying that, subject to the provisions of the certificate, the licensing authority have consented to the test in question and that certificate is for the time being in force and the test is to be carried out in accordance with that certificate.
3
Subject to the following provisions of this Act, no person shall import any medicinal product for the purposes of a medicinal test on animals unless either—
a
he is the holder of a product licence which authorises that test, 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
an animal test certificate has been issued certifying as mentioned in subsection (2)(b) of this section and that certificate is for the time being in force and the test is to be carried out in accordance with that certificate.
4
Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him, administer any substance or article to an animal by way of a medicinal test on animals, or procure any substance or article to be so administered, unless either—
a
in the case of a medicinal product, there is in force a product licence (whether held by him or by another person) which authorises that test and the product is administered in accordance with that licence or in accordance with any instructions required by the licence to be communicated to the person carrying out the test, or
b
whether the substance or article is a medicinal product or not, an animal test certificate has been issued certifying as mentioned in subsection (2)(b) of this section and that certificate is for the time being in force and the substance or article is administered in accordance with that certificate.
5
For the purposes of this section a product licence shall be taken to be a licence which authorises a particular medicinal test on animals if—
a
the substance or article to be administered in the test is a medicinal product 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 test.
6
In this Act “medicinal test on animals” means an investigation or series of investigations consisting of any of the following, that is to say—
a
the administration of a medicinal product of a particular description to one or more animals, where there is evidence that medicinal products of that description have effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals, and the product is administered for the purpose of ascertaining whether, or to what extent, it has those or any other effects, whether advantageous or otherwise;
b
the administration of a medicinal product to one or more animals in circumstances where there is no such evidence as is mentioned in the preceding paragraph, and the product is administered for the purpose of ascertaining whether, or to what extent, it has any effects relevant to a medicinal purpose;
c
the administration of any substance or article, other than a medicinal product, to one or more animals for the purpose of ascertaining whether it has any effects relevant to a medicinal purpose, whether there is evidence that it has effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals or not.