European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1990

JurisdictionIreland
CitationIR SI 171/1990

S.I. No. 171 of 1990.

EUROPEAN COMMUNITIES (CONTROL OF VETERINARY MEDICINAL PRODUCTS AND THEIR RESIDUES) REGULATIONS, 1990.

I, MICHAEL O'KENNEDY, Minister for Agriculture and Food, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving further effect to Council Directive No. 81/851/EEC(1) of 28 September, 1981, and Council Directive No. 86/469/EEC(2) of 16 September, 1986, hereby make the following Regulations:

(1) O.J. No. L317, 6.11.1981, p.01.

(2) O.J. No. L275, 26.09.1986, p.36.

1. (1) These Regulations may be cited as the European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1990.

(2) These Regulations and the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1988 ( S.I. No. 218 of 1988 ), may be cited together as the European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1988 and 1990.

(3) These Regulations shall come into operation on the 13th day of July, 1990.

2. (1) In these Regulations—

"authorised substance" means any substance in respect of which there is for the time being in force a product authorisation;

"the competent authority" means the National Drugs Advisory Board;

"the Council Directives" means—

( a ) Council Directive No. 81/851/EEC of 28 September, 1981, in so far as it relates to substances,

( b ) Council Directive No. 86/469/EEC of 16 September, 1986, in so far as it relates to substances, and

( c ) any act of the European Communities, adopted pursuant to the Council Directives aforesaid, in so far as it relates to substances;

"the Minister" means the Minister for Agriculture and Food;

"the Principal Regulations" means the European Communities (Control of Oestrogenic, Androgenic, Gestagenic and Thyrostatic Substances) Regulations, 1988 ( S.I. No. 218 of 1988 );

"product authorisation" means an authorisation granted under the Regulations of 1986 to place on the market a veterinary medicinal product;

"prohibited substance" means a substance which is not an authorised substance;

"the Regulations of 1986" means the European Communities (Veterinary Medicinal Products) Regulations, 1986 ( S.I. No. 22 of 1986 );

"substance" means—

( a ) a substance mentioned in Group III of Paragraph A (which group refers to inhibitors (antibiotics, sulphonamides and similar antimicrobial substances) and chloramphenicol) or in Group I of Paragraph B (which group refers to endo-parasitic and ectoparasitic substances, tranquillizers and beta-blockers, and other veterinary medicines) of Annex I to Council Directive 86/469/EEC of 16 September 1986, and

( b ) any preparation, additive, premixture, feedingstuff or other thing consisting of or containing any such substance as aforesaid;

"veterinary medicines legislation" means—

( a ) these Regulations,

( b ) the Animal Remedies Act, 1956 (No. 41 of 1956), and regulations made thereunder,

( c ) the Regulations of 1986,

( d ) the Poisons (Control of Residues in Foods of Animal Origin) Regulations, 1985 ( S.I. No. 257 of 1985 ), and

( e ) the Poisons (Control of Residues in Foods of Animal Origin) (Amendment) Regulations, 1986 ( S.I. No. 236 of 1986 ),

in so far as that Act and those Regulations relate to substances;

"veterinary medicinal product" has the meaning assigned to it by the Principal Regulations.

(2) A word or expression that is used in these Regulations and is also used in the Council Directives has, unless the contrary intention appears, the meaning in these Regulations that it has in the Council Directives.

(3) In these Regulations a reference to a Regulation shall be construed as a reference to a Regulation of these Regulations unless it is indicated that reference to some other provision is intended, and a reference in a provision to a paragraph or subparagraph shall be construed as a reference to a paragraph or subparagraph of that provision, unless it is indicated that reference to some other provision is intended.

3. (1) The Principal Regulations shall be construed and have effect as if—

( a ) except in Regulations 2, 11, 12, 13 (3) (b), 21 (2) (c) and 22, references to authorised substances (within the meaning of the Principal Regulations) included references to authorised substances,

( b ) except in Regulation 2, references to prohibited substances (within the meaning of the Principal Regulations) included references to prohibited substances,

( c ) references to substances (within the meaning of the Principal Regulations) included references to substances,

( d ) references to hormone legislation included references to veterinary medicines legislation, and

( e ) references to the Council Directives (within the meaning of the Principal Regulations) included references to the Council Directives.

(2) Regulation 13 (2) of the Principal Regulations shall not apply—

( a ) to the possession or control of an authorised substance by a person for the purposes of administration by him or under his direction to animals of any particular kind under his care if—

(i) the product authorisation concerned permits the use of the substance in animals of that kind,

(ii) the product authorisation permits the use of the substance by that person, and

(iii) the veterinary medicines legislation has been complied with in respect of the substance,

or

( b ) to the possession or control of a substance, or anything to which Regulation 8 of the Principal Regulations applies, by a person who is the holder of a licence under Regulation 5 or 7 relating to that substance or, as the case may be, to the substance to the manufacture or administration of which that thing relates.

(3) Regulation 32 (6) of the Principal Regulations is hereby amended as respect offences committed after the commencement of these Regulations by the substitution of "two years" for "one year".

4. (1) Subject to paragraph (2), a person shall not, except under and in accordance with a licence under Regulation 5, administer any substance to a farm animal, or cause or permit any such administration.

(2) Paragraph (1) shall not apply to the administration of an authorised substance to a farm animal of any particular kind where—

( a ) the administration is carried out in accordance with the provisions of the product authorisation concerned, the Council Directives and the veterinary medicines legislation, and

( b ) the product authorisation concerned authorises the administration of the substance to farm animals of that kind, and

( c ) the product authorisation authorises the use of the substance by that person, and

( d ) the veterinary medicines legislation has been complied with in respect of the substance.

(3) ( a ) A person who administers, or authorises, directs or permits the administration of, an authorised substance to a farm animal shall—

(i) act in conformity with the conditions of use of the substance ( other than those relating to the animal that fall to be complied with after such administration), and

(ii) if the person is not the owner or the person in charge of the animal, inform the owner or person in charge of the animal—

(I) of the conditions of use of the substance relating to the animal that fall to be complied with after such administration, and

(II) that the animal may not be slaughtered for human consumption, or sold or exported if it is intended to be slaughtered for human consumption, during the withdrawal period specified in the conditions of use.

( b ) The owner or person in charge of an animal to which an authorised substance has been administered—

(i) shall comply with the conditions of use of the substance relating to the animal that...

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