Animal Remedies Act, 1993
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Regulations as to animal remedies, etc. |
8.—(1) (a) Subject to subsection (6), the Minister may, after consultation with the Consultative Committee, make regulations relating to— | |
(i) animal remedies, | ||
(ii) ingredients for animal remedies, | ||
(iii) machinery, instruments and other things used, or with reasonable cause suspected of being or having been used, in the manufacture, importation, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of animal remedies, | ||
(iv) the advertisement or other promotion of animal remedies or ingredients of animal remedies, | ||
(v) animals treated with animal remedies, or with reasonable cause suspected of having been so treated, | ||
(vi) food derived or to be derived from animals treated with animal remedies or from the carcases of such animals, or with reasonable cause suspected of having been, being or to be so derived, | ||
(vii) the levels or amount (including a zero level or amount) of any specified substance or class of substance, being an animal remedy or ingredient for an animal remedy, which if exceeded in any animal, carcase of any animal or food derived from any animal would render it unsuitable for human consumption or unsuitable for animal consumption, and | ||
(viii) either or both the identification and marking of animals. | ||
(b) Regulations under this section may— | ||
(i) provide that if an animal remedy is a therapeutic substance to which the Therapeutic Substances Act, 1932 , applies, that Act shall cease to apply, either wholly or to a specified extent to the remedy, | ||
(ii) be made in respect of all or any one or more of the matters set out in paragraph (a) or in respect of any class or classes of such matters, | ||
(iii) provide for— | ||
(I) the granting of licences, the issuing of authorisations or the giving of directions by the Minister, or | ||
(II) the granting of licences, the issuing of authorisations, the giving of directions or the provision of services by such other person or persons, or such other class or classes of persons, as may be specified, | ||
in respect of any matter to which regulations under this Act relate, and | ||
(iv) contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purpose of implementing regulations under this section. | ||
(2) (a) In this subsection “control” includes the prohibition or restriction, or the prohibition or restriction save under licence of or under the authority (by way of authorisation) or direction of the Minister or such other person or class of persons as may be specified in regulations made under subsection (1). | ||
(b) Without prejudice to the generality of subsection (1) or section 9 , regulations made under that subsection may provide for— | ||
(i) the control of— | ||
(I) the manufacture, importation, preparation, handling, storage, transport, exportation, distribution, advertisement or other promotion, sale, supply or possession of any animal remedy or any ingredient for an animal remedy, | ||
(II) the administration of an animal remedy or ingredient for an animal remedy to an animal or the use of such animal remedy or ingredient for any other purpose, | ||
(III) the movement to or from any place of any animal to which any animal remedy or ingredient for an animal remedy has been administered or with reasonable cause is suspected of having been so administered, | ||
(IV) the importation, exportation, slaughter, distribution, sale, supply or possession of any animal to which any animal remedy or ingredient for an animal remedy has been administered or with reasonable cause is suspected of having been so administered, | ||
(V) the movement to or from any place of any animal which is not or has not been identified or marked otherwise than in accordance with this Act and the regulations made thereunder (including regulations deemed to have been made or continued in force by virtue of section 8 (8) or 31 (1)), | ||
(ii) the control (including the marking, detention and seizure) of any animal or carcase of any animal in respect of which any animal remedy or ingredient for an animal remedy— | ||
(I) is with reasonable cause suspected of having been administered or used, otherwise than in accordance with this Act and the regulations made thereunder (including regulations deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1)), until it, or a sample therefrom, has been duly inspected, examined, tested or analysed, or | ||
(II) has been administered or used otherwise than in accordance with this Act and the regulations made thereunder (including regulations deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1)), | ||
(iii) subject to subsection (7), the destruction of any animal or carcase of any animal, or of any kind of animal or carcase of such animal, in respect of which any animal remedy or ingredient for an animal remedy has been administered or used, being an animal remedy or ingredient for an animal remedy which is for the time being, or was at the time of such administration or use, prohibited by this Act or the regulations made thereunder (including regulations deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1)) from such administration or use, | ||
(iv) (I) the control (including the marking, labelling, detention, seizure, disposal and destruction) of any animal remedy or ingredient for an animal remedy, or | ||
(II) the detention of anything which, with reasonable cause, is suspected of being an animal remedy or ingredient for an animal remedy until it, or a sample thereof, has been duly inspected, examined, tested or analysed, | ||
which is being or has been manufactured, imported, prepared, handled, stored, transported, exported, distributed, sold, supplied, used or possessed otherwise than in accordance with this Act and the regulations made thereunder (including regulations deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1)), | ||
(v) the control (including the marking and labelling) on— | ||
(I) the transfer, sale or use or the detention of any food until it, or a sample thereof, has been duly inspected, examined, tested or analysed, or | ||
(II) the disposal of such food, | ||
which food is with reasonable cause suspected of having been derived from an animal (including food derived from its carcase), in respect of which— | ||
(A) an animal remedy or ingredient for an animal remedy was suspected of having been administered or used otherwise than in accordance with this Act and the regulations made thereunder (including regulations deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1)), or | ||
(B) the levels or amount of any specified substance or class of substance exceeds that provided for by virtue of regulations made under subsection (1) (a) (vii), | ||
(vi) the control (including the marking, labelling, detention, seizure, disposal and destruction) of any food derived from an animal (including food derived from its carcase) in respect of which— | ||
(I) an animal remedy or ingredient for an animal remedy was administered or used otherwise than in accordance with this Act and the regulations made thereunder (including regulations deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1)), or | ||
(II) the levels or amount of any specified substance or class of substance exceeds that provided for by virtue of regulations made under subsection (1) (a) (vii), | ||
(vii) the inspection, examination or carrying out of tests and analyses— | ||
(I) on any animal, animal carcase or food derived from, or with reasonable cause suspected of having derived from, an animal or an animal carcase, or on any specimen from such animal or animal carcase or sample from such food, | ||
(II) on any substance to establish whether or not such substance is an animal remedy or an ingredient for an animal remedy, or | ||
(III) on any thing to which subsection (1) (a) (iii) relates, | ||
and for the charging of fees or levies on or in respect of either or both such tests and analyses and for the manner of proving in any proceedings of documents certifying the results of any such inspection or examination or of any test or analysis so carried out, | ||
(viii) the specification of methods, processes, safeguards or precautions which are to be observed in respect of any control referred to in this subsection, | ||
(ix) the manner of proving in any proceedings of any document, being a licence, authorisation or direction of the Minister or such other person or class of persons as may be specified by regulations made under subsection (1), and | ||
(x) the purpose of giving effect or further effect to existing or future acts of the institutions of the European Communities which relate to— | ||
(I) veterinary medicinal products, or | ||
(II) residues of veterinary medicinal products in animals or foodstuffs, or | ||
(III) any other matter in respect of which the Minister may make regulations in respect of any other provision specified in this subsection or in subsection (1). | ||
(3) Where the Minister makes regulations under this section which include or are for the purpose of giving effect to an act of one of the institutions of the European Communities then— | ||
(a) that fact, together with the institution and act concerned, shall be specified by the Minister when making those regulations, and | ||
(b) the provisions of section 4 (inserted by the European Communities (Amendment) Act, 1973 ) of the Act of 1972 shall apply to those regulations as if they had been made under section 3 of the Act of 1972. | ||
(4) Subject to subsection (6), the Minister may, after consultation with the Consultative Committee, by regulations specify that some or all of the particulars— | ||
(a) set out in subsection (1) or (5) (b) (ii) of section 4 , or | ||
(b) specified in regulations made under subsection (7) of section 4 , | ||
need not be published in relation to certain types of animal remedies or to certain forms of advertisement or other promotion where the Minister is satisfied that, having regard to the type of animal remedy or to the form of advertisement or other promotion, it would not be reasonable or practicable to require such publication. | ||
(5) The Minister may— | ||
(a) in the case of regulations made under section 14 (as amended by the Misuse of Drugs Act, 1977 ) of the Poisons Act, 1961 , after consultation with the Consultative Committee, Comhairle na Nimheanna, and the Minister for Health, | ||
(b) in the case of regulations made under section 15 of the Poisons Act, 1961 , after consultation with the Consultative Committee and Comhairle na Nimheanna, | ||
provide by regulations that some or all of the provisions required by regulations made under section 14 (as so amended) or 15 of the Poisons Act, 1961 , shall not apply to— | ||
(i) animal remedies or ingredients of animal remedies, | ||
(ii) a specified class or classes of animal remedies or ingredients of animal remedies, or | ||
(iii) a specified animal remedy or ingredient for an animal remedy. | ||
(6) (a) Subject to paragraph (b), regulations under this section which, if made, would have the effect of prohibiting the supply or sale, in any of the circumstances set out in subparagraph (i) or (ii) of paragraph (a) of subsection (5) of section 4 , of all animal remedies or of animal remedies of a particular class or description shall not be made unless— | ||
(i) Dáil Éireann has by resolution consented to such prohibition, or | ||
(ii) the prohibition is necessary for the purpose of enabling section 2 of the Act of 1972 to have full effect. | ||
(b) This subsection shall not apply to any regulation which prohibits generally the sale or supply— | ||
(i) of an animal remedy or an ingredient for an animal remedy, or | ||
(ii) of any class of animal remedy, or any class of ingredient for an animal remedy, or | ||
(iii) except under licence, authorisation or direction, of all or any class of animal remedy or all or any class of ingredient for an animal remedy. | ||
(7) Where regulations to which subsection (2) (b) (iii) relate have been made in respect of animals or any kind of animal whose destruction is provided for under those regulations, the Minister may, subject to such conditions (if any) as the Minister considers appropriate in the circumstances to impose, exempt from such destruction any animal so provided for which is imported into the State and to or in respect of which an animal remedy or ingredient for an animal remedy has been lawfully administered or used outside the State. | ||
(8) (a) The regulations made under the Act of 1972 which are set out in paragraph (b) and the regulations made under the Poisons Act, 1961 , which are set out in paragraph (c) shall, subject to sections 20 (2) and 32 (2) of, and the Schedule to, this Act be deemed to have been made under this section and, in the case of the regulations set out in paragraph (b), the provisions of subsection (3) shall be deemed to have been complied with. | ||
(b) The following are the regulations made under the Act of 1972 to which paragraph (a) relates, that is to say: | ||
(i) the European Communities (Veterinary Medicinal Products) Regulations, 1986; | ||
(ii) the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1988 ( S.I. No. 218 of 1988 ); | ||
(iii) the European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1990 ( S.I. No. 171 of 1990 ). | ||
(c) The following are the regulations made under the Poisons Act, 1961 , to which paragraph (a) relates, that is to say: | ||
(i) the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985 ( S.I. No. 257 of 1985 ); | ||
(ii) the Poisons (Control of Residues in Foods of Animal Origin) (Amendment) Regulations, 1986 ( S.I. No. 236 of 1986 ). | ||
(9) In this section— | ||
“the Act of 1972” means the European Communities Act, 1972 ; | ||
“European Communities” has the same meaning as it has in the Act of 1972. |