European Communities (Veterinary Medicinal Products) Regulations, 1986

JurisdictionIreland
CitationIR SI 22/1986

S.I. No. 22 of 1986.

EUROPEAN COMMUNITIES (VETERINARY MEDICINAL PRODUCTS) REGULATIONS, 1986.

The Minister for Health, in exercise of the powers conferred on him by section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations:

1. These Regulations may be cited as the European communities (Veterinary Medicinal Products) Regulations, 1986.

2. (1) In these Regulations—

"the Council Directive" means Council Directive 81/851/EEC1.

"a product authorisation" means an authorisation to market a veterinary medicinal product.

(2) In these Regulations words and phrases shall have the same meanings as in the Council Directive.

3. The competent authority in the State for the purpose of the Council Directive shall be the National Drugs Advisory Board.

4. The competent authority may, where it considers it appropriate, exempt from the provisions of the Regulations veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals and small rodents in pursuance of article 3 of the Council Directive, provided that the conditions for so doing, as set out in the said article 3 are satisfied.

5. (1) A person shall not place on the market a veterinary medicinal product, coming on the market for the first time on or after the 1st day of January, 1987, save in accordance with the provisions of the Council Directive and with a product authorisation granted or renewed by the competent authority.

1Official Journal of the European Communities, No. L317 6/11/81 (Pages 1-15).

(2) On and after the date specified in the second column of the Schedule to these Regulations opposite the mention of a class of veterinary medicinal products in the first column of the Schedule a person shall not place on the market a veterinary medicinal product of that class save in accordance with the provisions of the Council Directive and with a product authorisation granted or renewed by the competent authority.

(3) An application for a product authorisation for a veterinary medicinal product of a class of veterinary medicinal products in the first column of the Schedule to these Regulations shall be made to the competent authority at least twelve months before the date specified in the second column of the Schedule opposite the mention of the class.

6. (1) The competent authority may grant or renew a product authorisation to any person who applies for such authorisation in accordance with article 7.

(2) Unless sooner withdrawn by the competent authority, a product authorisation shall remain in force for a period of five years and may be renewed on application by the holder.

7. (1) An application for a product authorisation shall be made to the competent authority and the application shall—

( a ) be in such form as the competent authority may require and be accompanied by the appropriate fee required under article 14 of these Regulations and by the particulars and documents specified in article 5 of the Council Directive, and

( b ) where the documents and particulars relate to matters referred to in points 8, 9 or 10 of article 5 of the Council Directive, be drafted and signed by experts with the requisite technical or...

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