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PART IILicences and Certificates Relating to Medicinal Products

Medicated animal feeding stuffs

40General provisions relating to medicated animal feeding stuffs

(1)No person shall, in the course of a business carried on by him, sell, offer for sale, supply or export, or procure the sale, supply or exportation or the manufacture for sale, supply or exportation of, any animal feeding stuff in which a medicinal product has been incorporated, unless—

(a)a product licence or animal test certificate (whether held by him or by another person) is for the time being in force which contains provisions relating to the incorporation of medicinal products in animal feeding stuffs, and the licence or certificate, and those provisions in particular, are applicable to medicinal products of that description, and the product was incorporated in accordance with the licence or certificate, or

(b)the medicinal product was incorporated in the animal feeding stuff in accordance with a prescription given by a veterinary surgeon or veterinary practitioner for the treatment of a particular animal or herd to which the feeding stuff is to be fed and which is under the care of that veterinary surgeon or veterinary practitioner.

(2)No person shall import any animal feeding stuff in which a medicinal product has been incorporated unless the conditions specified in paragraph (a) or paragraph (b) of the preceding subsection are fulfilled.

(3)No person shall, in the course of a business carried on by him, incorporate a medicinal product of any description in any animal feeding stuff unless—

(a)a product licence or animal test certificate (whether held by him or by another person) is for the time being in force which contains provisions relating to the incorporation of medicinal products in animal feeding stuffs, and the licence or certificate, and those provisions in particular, are applicable to medicinal products of that description, and the product is incorporated in accordance with the licence or certificate, or

(b)the medicinal product is incorporated in the animal feeding stuff in accordance with a prescription given by a veterinary surgeon or veterinary practitioner for the treatment of a particular animal or herd to which the feeding stuff is to be fed and which is under the care of that veterinary surgeon or veterinary practitioner.

41Transitional provisions as to restrictions under s. 40

(1)The provisions of section 40 of this Act shall have effect subject to the following provisions of this section.

(2)The restrictions imposed by that section do not apply to anything done before the first appointed day.

(3)The restrictions imposed by subsection (1) of that section do not apply to anything done on or after the first appointed day in relation to any animal feeding stuff in which a medicinal product of any description has been incorporated, and the restrictions imposed by subsection (3) of that section do not apply to anything done on or after that day which consists of incorporating a medicinal product of any description in any animal feeding stuff, if (in either case) it is done—

(a)before the date on which, by virtue of one or more orders under section 17 of this Act, section 16(2) of this Act ceases to have any effect in relation to medicinal products of that description, or

(b)before the end of the period of twelve months beginning with that date.

(4)The restriction imposed by section 40(2) of this Act does not apply to the importation on or after the first appointed day of any animal feeding stuff in which a medicinal product of any description has been incorporated if it is imported—

(a)before the date on which, by virtue of one or more orders under section 17 of this Act, section 16(3) of this Act ceases to have any effect in relation to medicinal products of that description, or

(b)before the end of the period of twelve months beginning with that date.

42Supplementary provisions as to incorporation of substances and articles in animal feeding stuffs

(1)Where in the course of a business carried on by him a person incorporates a substance or article, other than a medicinal product, in any animal feeding stuff with a view to—

(a)feeding it, with the substance or article incorporated in it, to one or more animals, or

(b)selling, supplying or exporting it with the substance or article incorporated in it,

and the substance or article is so incorporated by him for a medicinal purpose, sections 40(3) and 41 of this Act shall have effect in relation to the incorporation of that substance or article as if it were a medicinal product.

(2)Where in the course of a business carried on by him a person proposes—

(a)to sell or supply a substance or article, other than a medicinal product, to persons who for a medicinal purpose may require to incorporate it in animal feeding stuffs to be fed to one or more animals, or

(b)to manufacture a substance or article, other than a medicinal product, for sale or supply as mentioned in the preceding paragraph,

he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to sell or supply it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.

(3)Where a person proposes to sell, supply or manufacture a substance or article, other than a medicinal product, in the circumstances specified in paragraph (a) or paragraph (b) of subsection (2) of this section, any person who proposes, by purchase or otherwise, to obtain from him a supply of the substance or article with a view to incorporating it for a medicinal purpose in any animal feeding stuff may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to procure the sale or supply, or the manufacture for sale or supply, of that product in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended revoked or varied accordingly.

(4)On the grant, renewal or variation (whether by virtue of subsection (2) or subsection (3) of this section or otherwise) of a product licence, in so far as it relates to any substance or article which is to be incorporated in animal feeding stuffs, the licence may (without prejudice to the generality of section 20(1) of this Act) include provisions as to the manner in which the substance or article in question may be so incorporated, whether by the holder of the licence or by any other person to whom those provisions of the licence have been communicated.

(5)Without prejudice to the operation of section 130(7) of this Act, a substance manufactured, sold, supplied or exported as an animal feeding stuff shall not be taken to be a medicinal product for the purposes of this Act by reason only that any of the preceding provisions of this section has effect in relation to a substance or article incorporated in it.

(6)The appropriate Ministers may by order provide that any of the provisions of section 40 of this Act or of subsections (1) to (5) of this section shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

(7)No order shall be made under subsection (6) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.