Animal Remedies Act, 1993
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Disclosure of composition of animal remedies. |
4.—(1) Subject to the provisions of this section, no person shall sell or import an animal remedy unless the container in which it is sold or imported and any outer wrapper bear a notice clearly indicating— | |
(a) (i) the appropriate commercial common name of the remedy or, if it contains more than one ingredient, of each ingredient and the proportion thereof in the remedy, | ||
(ii) if the remedy or any ingredient has not an appropriate commercial common name, the appropriate scientific name of such remedy or ingredient, or | ||
(iii) if the remedy consists solely of a therapeutic substance in respect of which a licence or permit granted under the Therapeutic Substances Act, 1932 , is in force, the name of the substance as stated in the licence or permit and the number of the licence or permit, | ||
(b) the specific remedial property or properties claimed for the remedy, | ||
(c) (i) in a case where the remedy is imported in bulk and packed in the State, the name and address of the importer and packer of the remedy, | ||
(ii) in a case where the remedy is manufactured in the State for and under the control of a person who manufactures the same remedy or causes it to be manufactured outside the State, the name and address of that person and that the remedy is manufactured in the State for and under the control of that person and, where appropriate, the name and address of the packer or, where the remedy is not distributed by the manufacturer or packer, of the distributor of the remedy, or | ||
(iii) in any other case, the name and address of the manufacturer and (where different) the packer of the remedy, | ||
and | ||
(d) such other particulars as may be prescribed from time to time by regulations made by the Minister after consultation with the Consultative Committee. | ||
(2) Subject to the provisions of this section, no person shall publish or cause to be published an advertisement or other promotion for an animal remedy unless such advertisement or other promotion contains the particulars specified in subsection (1) or the particulars provided in lieu of such of those so specified as are provided for by virtue of regulations made under subsection (7). | ||
(3) Subsection (1) shall not apply to the importation in bulk of an animal remedy otherwise than in the container or outer wrapper in which it is intended to be put on sale. | ||
(4) Subsection (2) shall not apply to an advertisement or other promotion published or caused to be published by the Minister or to scientific information published or caused to be published by a university or other third level educational institution or by a professional or scientific institution or association. | ||
(5) (a) Subject to paragraph (b), subsections (1) and (2) shall not apply to an animal remedy which— | ||
(i) is supplied by a registered veterinary surgeon to a person for the treatment of an animal which is owned by or ordinarily in the custody of that person and concerning which that person has consulted the veterinary surgeon in the course of that veterinary surgeon's private and professional practice, or | ||
(ii) is supplied, in accordance with an individual prescription of a registered veterinary surgeon, and is sold by a registered pharmaceutical chemist, a registered druggist or a registered dispensing chemist and druggist to the person named in the prescription, or | ||
(iii) is a medical preparation intended for humans and in respect of which the Minister for Health has granted or renewed a product authorisation under the provisions of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 and 1989, and the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1993 ( S.I. No. 70 of 1993 ). | ||
(b) As respects a veterinary medicinal product (being a veterinary medicinal product to which the European Communities (Veterinary Medicinal Products) Regulations, 1986 ( S.I. No. 22 of 1986 ), relate) for which there is a subsisting product authorisation under those Regulations— | ||
(i) the provisions of paragraphs (a), (b) and (c) of subsection (1) shall not apply, | ||
(ii) the reference in subsection (2) to the particulars specified in subsection (1) shall be construed as a reference to the labelling requirements of Chapter VII of Council Directive No. 81/85I/EEC of 28 September 1981(b) , and | ||
(iii) the provisions of subparagraphs (i) and (ii) of paragraph (a) shall not have effect. | ||
(6) The Minister may require— | ||
(a) any person who sells an animal remedy to satisfy the Minister of the accuracy of any statement on the container or outer wrapper of such remedy or of any other information provided with the intention of being supplied with the remedy, | ||
(b) any person who causes to be published an advertisement or other promotion for an animal remedy to satisfy the Minister of the accuracy of any statement contained in the advertisement or other promotion, | ||
and any such requirement shall be complied with. | ||
(7) In the application of subsection (1) to animal remedies or to any class or classes of animal remedy, the Minister may, in respect of remedies or such class or classes and after consultation with the Consultative Committee, by regulations— | ||
(a) provide for other particulars in lieu of those provided for in paragraphs (a), (b) and (c) of subsection (1), or in lieu of any of them, but only if— | ||
(i) in addition to such other particulars (if any) as the Minister considers appropriate to so provide, the regulations provide that the active ingredients of such class or classes and the indications for use of an animal remedy on such class or classes are indicated, or | ||
(ii) the animal remedies or class or classes of animal remedies to which the regulations relate are for export and the person concerned has been duly licensed so to export, | ||
and | ||
(b) extend such application, or so provide for other particulars in lieu thereof, in respect of any class or classes of remedy which is supplied or sold in accordance with subparagraph (i) or (ii) of paragraph (a) of subsection (5). | ||
(8) Upon the commencement of this section, the regulations then in force under section 8 , or continued in force or deemed to have been made under that section by virtue of section 8 (8) or 31 (1), shall apply to an animal remedy which is sold or imported from an official veterinary research laboratory recognised by the Minister or which is exported from the State. | ||
(9) Without prejudice to the provisions of section 8 , the Minister may, after consultation with the Consultative Committee, make regulations providing for the disclosure of the composition, whether by labelling or by any other means, of— | ||
(a) animal remedies to which subsection (1) does not apply by virtue of subsection (3), or | ||
(b) ingredients for animal remedies. | ||
(10) In this section— | ||
“appropriate scientific name” means— | ||
(a) in a case where the remedy or ingredient is one in respect of which regulations made under section 14 of the Poisons Act, 1961 , declare it to be a poison and for the time being require it to be named in a particular way, the name with which the container of such poison is required to be so labelled, | ||
(b) in a case where the remedy or ingredient is not a poison to which paragraph (a) of this definition applies but is described in any of the monographs contained in the edition of the Irish Pharmacopoeia which was last published before the date on which such remedy or the remedy containing such ingredient was manufactured or imported, the description set out at the head of that monograph, | ||
(c) in a case where neither paragraph (a) or (b) of this definition is applicable but the remedy or ingredient is described in any of the monographs contained in the European Pharmacopoeia which was last published before the date on which such remedy or remedy containing such ingredient was manufactured or imported, the description set out at the head of that monograph, or | ||
(d) in any other case, the accepted scientific name or other name descriptive of the true nature of the remedy or ingredient; | ||
“European Pharmacopoeia” means the Pharmacopoeia elaborated under the auspices of the Council of Europe in pursuance of the Convention in that behalf done at Strasbourg on the 22nd day of July, 1964; | ||
“Irish Pharmacopoeia” means the Pharmacopoeia provided for by the Pharmacopoeia Act, 1931 ; | ||
“registered dispensing chemist and druggist” means a person registered in the register of dispensing chemists and druggists established under the Pharmacy Act, 1951 ; | ||
“registered druggist” means a person registered in the register of registered druggists in Ireland established under the Pharmacy Act (Ireland), 1875, Amendment Act, 1890; | ||
“registered pharmaceutical chemist” means a person registered in the register of pharmaceutical chemists for Ireland established under the Pharmacy Act (Ireland), 1875; | ||
“registered veterinary surgeon” means a person registered in the register established under the Veterinary Surgeons Act, 1931 . | ||