Animal Remedies Act , 1993

1 Interpretation.

1.—(1) In this Act, unless the context otherwise requires—

“administration”, in relation to an animal remedy, means administration or application to an animal, whether internally or externally, and includes oral, parenteral, and topical administration or application, and the administration or application—

(a) by inhalation,

(b) by incorporation in food or water, or

(c) by means of automatic machines or processes,

and cognate words shall be construed accordingly;

“advertisement or other promotion” includes any form of advertising or other promotion by means of—

(a) radio, television, computer monitor, telephone or other like means of communication,

(b) a recording, whether mechanical or electronic, and

(c) a notice, poster, pamphlet, circular, label, wrapper or other like document;

“animal”, except in the definition of “substance” and section 11 (1) (e), means any animal in relation to which this Act applies by virtue of section 2;

“animal remedy” means any substance or combination of substances which—

(a) is intended for administration to animals,

(b) may be administered to animals, or

(c) is, whether expressly or by implication, presented for administration to animals,

for the purpose of—

(i) treating, preventing or modifying disease in animals,

(ii) making a medical or surgical diagnosis in animals,

(iii) restoring, correcting or modifying physiological functions in animals, or

(iv) except for a substance or combination of substances being a feedingstuff commonly known and solely used as such, otherwise improving the health or condition of animals;

“authorised officer”, subject to section 18, means a person authorised in writing by the Minister under section 10 to be an authorised officer for the purposes of some or all of the provisions of this Act or deemed to have been appointed an authorised officer by virtue of, and for the purposes set out in, section 31 (2);

“carcase” includes part of a carcase, whether edible or not, including blood and offal;

“the Consultative Committee” means the committee referred to in section 3;

“disease” includes any injury, ailment or defect;

“document” includes any book and any other record, whether legible or in a machine readable form;

“European Communities” has the meaning assigned to it by section 1 (1) of the European Communities Act, 1972;

“functions” includes powers and duties;

“human consumption” includes intended for incorporation in, or manufacture into, a food intended for human consumption;

“land”, where the context admits, includes land covered by water, and references to in, on, under or from any land shall be construed accordingly;

“manufacture” means total or partial manufacture and includes processing, compounding, formulating, filling, dividing up, packing, labelling and presentation and cognate words shall be construed accordingly;

“the Minister” means the Minister for Agriculture, Food and Forestry;

“prohibited animal remedy” means any animal remedy or ingredient for an animal remedy in respect of which—

(a) by virtue of regulations made under section 8 or, where appropriate, deemed to have been so made or continued in force by virtue of section 8 (8) or 31 (1), a licence, authorisation or direction is required to have been issued for the purpose of its administration to an animal or for its use for other purposes, and

(b) either—

(i) such licence, authorisation or direction has not been so issued, or

(ii) where such licence, authorisation or direction has been so issued, any condition or other requirement to which it is subject to has not been complied with or is no longer complied with;

“sell” includes offer, expose or keep for sale, invite an offer to buy, or distribute for reward and cognate words shall be construed accordingly;

“supply” includes giving without payment;

“substance” means any matter irrespective of origin, whether such matter is of—

(a) human origin (including human blood and human blood products),

(b) animal origin (including micro-organisms, whole or parts of animals, parts of organs and animal secretions, toxins, antitoxins, sera, antisera, extracts and blood products),

(c) vegetable origin (including micro-organisms, plants, parts of plants and vegetable secretions or extracts),

(d) chemical origin (including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis),

(e) any other substance within the meaning of paragraph 3 of Article 1 of Council Directive No. 65/65/EEC of 26 January 1965[^(a)], or

(f) any combination of the foregoing;

“vehicle” includes a ship, hovercraft, aircraft and offshore installation (being an offshore installation within the meaning assigned to it by section 2 (1) of the Safety, Health and Welfare (Offshore Installations) Act, 1987).

(2) A word or phrase that is used in this Act in respect of a matter which gives effect to an act of the European Communities relating to animal remedies and which is also used in the said act of the European Communities has, except where the context otherwise requires, the same meaning as it has in the said act of the European Communities.

(3) (a) A reference in this Act to a section is a reference to a section of this Act unless it is indicated that a reference to some other Act is intended.

(b) A reference in this Act to a subsection or to a paragraph is to the subsection or paragraph of the provision in which the reference occurs unless it is indicated that reference to some other provision is intended.

2 Animals to which this Act applies.

2.—(1) This Act applies in relation to the following animals, that is to say, mammals (other than humans), birds, fish, reptiles, molluscs, crustaceans and honey bees (Apis mellifera) and any other animal kept for human consumption or any of whose produce is intended for human consumption.

(2) (a) The Minister may by order apply this Act or any provision of this Act, including any regulations made thereunder, to any other kind of animal, being—

(i) a domestic animal,

(ii) a wild animal in captivity, or

(iii) any other wild animal.

(b) The Minister may by order amend or revoke an order under this subsection, including an order under this paragraph.

3 Animal Remedies Consultative Committee.

3.—(1) Notwithstanding the repeal of the Animal Remedies Act, 1956, the Animal Remedies Consultative Committee established by virtue of section 4 of that Act shall continue in being for the purpose of advising and assisting the Minister in the making of regulations under this Act and shall continue to be known as the Animal Remedies Consultative Committee.

(2) (a) The Consultative Committee shall consist of 9 members appointed from time to time by the Minister, of whom two shall be directly appointed by the Minister and, subject to paragraph (b), one each shall be appointed by the Minister on the nomination of—

(i) the Minister for Health,

(ii) the Pharmaceutical Society of Ireland,

(iii) the Veterinary Council established under the Veterinary Surgeons Act, 1931,

(iv) one or more organisations prescribed, for the time being, for the purpose of this subparagraph which, in the opinion of the Minister, are representative of persons whose profession or occupation relates to the manufacture, distribution, sale or supply of animal remedies,

(v) one or more organisations prescribed, for the time being, for the purpose of this subparagraph which, in the opinion of the Minister, are representative of persons whose profession or occupation relates to livestock farming or the keeping or rearing of animals to which this Act applies or to the use of animal remedies,

(vi) one or more organisations prescribed, for the time being, for the purpose of this subparagraph which, in the opinion of the Minister, are concerned with the production of food of animal origin or the promotion or development of the food industry, and

(vii) one or more organisations prescribed, for the time being, for the purpose of this subparagraph which, in the opinion of the Minister, are concerned with consumer interests.

(b) Where an organisation or organisations duly prescribed under subparagraph (iv), (v), (vi) or (vii) of paragraph (a) for the purpose of nominating a person to be appointed as a member of the Consultative Committee fail to duly nominate a person, the Minister may, in the place of such a person, appoint to the Committee a person who, in the opinion of the Minister and having regard to the interests involved, would be an appropriate person to have been nominated as such a member for those interests.

(c) In this subsection “prescribed” means prescribed by regulations made by the Minister for the purpose of this subsection.

(3) Every member of the Consultative Committee shall, unless such member previously dies or resigns, hold office for—

(a) a period of four years from the date of appointment, or

(b) such other period, being a period not greater than two years, which is determinable by the occurrence of any event specified in writing at the time of appointment by the Minister,

whichever is the shorter, and any member or former member shall be eligible for re-appointment.

(4) There may be paid to members of the Consultative Committee such expenses of travel and subsistence as the Minister, with the consent of the Minister for Finance, may determine.

(5) The Consultative Committee shall meet whenever summoned by the Minister.

(6) The Consultative Committee may regulate its own procedure for the purpose of considering matters referred to it by the Minister.

(7) The Minister shall, as soon as is practicable after the commencement of this section, appoint in accordance with subsection (2) so many persons to be members of the Consultative Committee as are necessary to bring the number of such members up to nine.

(8) Subject to the foregoing provisions of this section, the Minister may, by rules made under this section, regulate the times of appointment of members of the Consultative Committee, the time and mode of filling casual vacancies in the Consultative Committee, and the period of office of persons appointed to fill such casual vacancies.

4 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;