13 Medicated animal feeding stuffs.U.K.
(1)For section 40 of the M1Medicines Act 1968 (medicated animal feeding stuffs) there is substituted—
“40 Medicated animal feeding stuffs
(1)The Agriculture Ministers may by regulations prohibit the incorporation by any person, in the course of a business carried on by him, of a medicinal product of any description in an animal feeding stuff unless such of the conditions mentioned in subsection (2) of this section as may be specified in the regulations are satisfied.
(2)The conditions referred to in subsection (1) of this section are—
(a)that it is incorporated in accordance with provisions relating to the incorporation of the medicinal product in animal feeding stuffs contained in a product licence or animal test certificate (whether held by him or by another person);
(b)that it is incorporated in accordance with a written direction given by a veterinary surgeon or veterinary practitioner, being a written direction complying with such requirements as may be specified in the regulations;
(c)that the person concerned is for the time being entered in a register kept for the purposes of the regulations by the registrar or the Northern Ireland enforcement authority.
(3)A condition imposed by virtue of subsection (2)(a) of this section shall be taken to be satisfied if the person incorporating the medicinal product in the animal feeding stuff—
(a)is not the holder of a product licence or animal test certificate containing such provisions as are mentioned in that paragraph, but
(b)believes, on reasonable grounds, that another person is the holder of such a licence or certificate containing such provisions and that the medicinal product is incorporated in accordance with those provisions.
(4)The Agriculture Ministers may by regulations prohibit—
(a)the sale, offer for sale, supply or export by any person in the course of a business carried on by him of any animal feeding stuff in which a medicinal product has been incorporated, or
(b)the importation by any person of any animal feeding stuff in which a medicinal product has been incorporated,
unless such of the conditions mentioned in subsection (5) of this section as may be specified in the regulations are satisfied.
(5)The conditions referred to in subsection (4) of this section are—
(a)that the medicinal product was not incorporated in the animal feeding stuff in contravention of any prohibition imposed by virtue of subsection (1) of this section;
(b)that the feeding stuff is sold, offered for sale, supplied, exported or imported (as the case may be) in accordance with a written direction given by a veterinary surgeon or veterinary practitioner, being a written direction complying with such requirements as may be specified in the regulations;
(c)that the person concerned is for the time being entered in a register kept for the purposes of the regulations by the registrar or the Northern Ireland enforcement authority.
(6)A condition imposed by virtue of subsection (5)(a) of this section shall be taken to be satisfied if the person selling, offering for sale, supplying, exporting or importing the animal feeding stuff—
(a)did not incorporate the medicinal product in it, and
(b)had no reasonable grounds to believe that it was incorporated in contravention of any prohibition imposed by virtue of subsection (1) of this section.
(7)Regulations under this section may impose such conditions as the Agriculture Ministers think fit in respect of the inclusion or retention of persons in a register kept for the purposes of the regulations, including conditions requiring the payment to the registrar or the Northern Ireland enforcement authority of fees of such amounts as the Agriculture Ministers may with the consent of the Treasury determine.
(8)In determining any such fees, the Agriculture Ministers may have regard to—
(a)any costs incurred or to be incurred by the Pharmaceutical Society or the Northern Ireland enforcement authority in connection with any duty to enforce any provision of regulations under this section, and
(b)any costs incurred or to be incurred by any other person for the purpose of maintaining or improving standards among those engaged in the activities referred to in subsections (1) and (4) of this section.
(9)Any fees received by virtue of this section for the inclusion or retention of any person in a register kept for the purposes of the regulations shall, if the Agriculture Ministers so determine, be applied to such extent and in such manner as they may determine towards meeting any costs falling within subsection (8)(b) of this section; subject to that, any such fees received by the registrar shall be applicable for the purposes of the Pharmaceutical Society.
(10)A person contravenes this section if he contravenes any prohibition imposed by virtue of subsection (1) or (4) of this section.
(11)References in this Act to the incorporation of a medicinal product in an animal feeding stuff do not include a reference to it being so incorporated in the course of making a medicinal product; but, subject to that, they include a reference to the incorporation—
(a)for a medicinal purpose of a substance or article other than a medicinal product, or
(b)of a substance in which a medicinal product has been incorporated,
in an animal feeding stuff.
(12)In this section— “the Northern Ireland enforcement authority” means any Northern Ireland Department having a duty to enforce any provision of this section or of regulations under it; and “the registrar” means any person appointed under section 1 of the Pharmacy Act 1954 as registrar for the purposes of that Act.”
(2)In section 130 of the M2Medicines Act 1968 (meaning of medicinal product and related expressions) after subsection (3) there is inserted—
“(3A)An order made by the Agriculture Ministers may provide that, for the purposes of this Act, any specified description or class of medicated feeding stuff—
(a)is to be treated as a medicinal product (subject to the following provisions of this section), or
(b)is not to be so treated (notwithstanding anything in subsection (1) of this section).
(3B)In subsection (3A) of this section ”medicated feeding stuff’ means any substance which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say—
(a)use by being fed to one or more animals for a medicinal purpose or for purposes that include that purpose, or
(b)use as an ingredient in the preparation of a substance which is to be fed to one or more animals for a medicinal purpose or for purposes that include that purpose.
(3C)No order shall be made under subsection (3A) of this section unless a draft of the order has been laid before Parliament and approved by resolution of each House of Parliament.”
(3)In section 132(1) of the M3Medicines Act 1968 (interpretation), after the definition of “animal” there is inserted—
““animal feeding stuff” means any substance which is intended for use either by being fed to one or more animals or as an ingredient in the preparation of such a substance, not being in either case a medicinal product”.