sell or supply any medicinal product for the purposes of a medicinal test on animals, or

procure the sale or supply of any medicinal product for the purposes of such a test, or

procure the manufacture or assembly of any medicinal product for sale or supply for the purposes of such a test,

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;

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.

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

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.

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

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.

the substance or article to be administered in the test is a medicinal product of a description to which the licence relates, and

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.

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;

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;

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.

the test is, or is to be, carried out in circumstances where there is no evidence that the substance or article has effects which may be beneficial to, or otherwise advantageous in relation to, the animal or animals to which it is, or is to be, administered, and

the arrangements for the test are such as to secure that no animal to which the substance or article is administered in the course of the test, and no carcase or part of the carcase or produce of any such animal, will be sold or supplied for human consumption.

selling or supplying, or procuring the sale or supply of, a medicinal product for the purpose of its being administered to one or more animals which are under his care, or

procuring the manufacture or assembly of a medicinal product where the product is specially prepared to his order for the purpose of its being administered to one or more such animals, or

administering a substance or article to an animal which is under his care, or procuring a substance or article to be so administered.

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

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

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.

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 veterinary surgeon or veterinary practitioner who has stated that it is required for administration to an animal or herd which is under his care, or is required, at the request of another veterinary surgeon or veterinary practitioner, for administration to an animal or herd which is under the care of that other veterinary surgeon or veterinary practitioner, or

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

it 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.

in the case of a vaccine, it is specially prepared for administration to the animal from which it is derived, or

in the case of plasma or a serum, it has been specially prepared for administration to one or more animals in the herd from which it is derived.

at the time when the substance or article was so administered there was in force an animal test certificate issued in respect of that test, and

all the provisions of that certificate relating to the carrying out of the test and the disposal of the animal or its carcase or produce are, and have at all material times been, complied with.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

do not apply to the manufacture or assembly of any medicinal product for the sole purpose of its being administered by way of a medicinal test on animals, or of its being sold, supplied or exported for the sole purpose of its being so administered, unless the product falls within a class of medicinal products specified in an order made for the purposes of this paragraph by the Agriculture Ministers.

an animal test certificate has been issued and is for the time being in force in respect of that test, and the test is to be carried out in accordance with that certificate, and;

the product is so manufactured or assembled as to comply with any requirements of the certificate relating to the products to be administered in the F7... test,

the F10... test is, or is to be, carried out under arrangements to which he is not a party, and

he has not been informed of those arrangements.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

that section 32 of this Act shall have effect subject to such exemptions (other than those for the time being having effect by virtue of section 33 of this Act and subsection (4) of this section) as may be so specified.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

substances or articles have been administered by way of a medicinal test on animals,

F21substances or articles specified in the application were administered by way of a medicinal test on animals in the course of a series of investigations as mentioned in subsection (3) of this section, and

that series of investigations was in progress immediately before the first appointed day, and

the certificate is required for the purpose of continuing the series,

any reference in that section to a licence of right were a reference to such a certificate;

for the reference in subsection (2)(a) of that section to the grounds of refusal therein mentioned there were substituted a reference to the grounds that the conditions specified in subsection (4) of this section have not been fulfilled in relation to the application; and

in subsection (6) of that section the reference to sections 25 and 26 of this Act were a reference to subsection (4) of this section;

may renew the certificate, with or without modifications, for such a further period as is mentioned in subsection (2) of this section, or

may issue to the applicant a new F23... animal test certificate containing such provisions as the licensing authority consider appropriate, or

if, having regard to the provisions of this Act, they consider it necessary or expedient to do so, may refuse to renew the certificate or to issue a new certificate.

the certificate shall not cease to be in force by virtue of the preceding provisions of this section before the licensing authority have determined the application, and

if by an interim order made under section 107(3)(a) of this Act the operation of the decision of the licensing authority on the application is suspended, the certificate shall not cease to be in force by virtue of those provisions so long as the operation of the decision continues to be suspended by the order.

that the matters stated in the application on which the certificate was issued were false or incomplete in a material particular;

that any of the provisions of the certificate has to a material extent been contravened;

that medicinal products of any description to which the certificate relates, as sold, supplied, exported, imported, manufactured or assembled for the purposes of the F27... medicinal test on animals to which it relates, fail to a material extent to correspond to the characteristics by reference to which the certificate was issued;

that the holder of the certificate has without reasonable excuse failed to comply with a requirement imposed on him under section 44(2) of this Act to furnish information to the licensing authority with respect to any substances or articles to which the certificate relates;

that any such substances or articles can no longer be regarded as substances or articles which can safely be administered for the purposes of the F28... medicinal test on animals to which the certificate relates;

that the specification and standards to which any such substances or articles are manufactured can no longer be regarded as satisfactory.