S.I. No. 115/1980:

ANIMAL REMEDIES (REGISTRATION OF MANUFACTURERS, IMPORTERS AND WHOLESALERS) REGULATIONS, 1980.

ANIMAL REMEDIES (REGISTRATION OF MANUFACTURERS, IMPORTERS AND WHOLESALERS) REGULATIONS, 1980.

I, RAY MacSHARRY, Minister for Agriculture, in exercise of the powers conferred on me by section 7 of the Animal Remedies Act, 1956 (No. 41 of 1956), as adapted by the Agriculture and Fisheries (Alteration of Name of Department and Title of Minister) Order, 1977 ( S.I. No. 31 of 1977 ), and after consultation with the Animal Remedies Consultative Committee, hereby make the following Regulations:

1. (1) These Regulations may be cited as the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations, 1980.

(2) These Regulations shall come into force on the 1st day of June, 1980.

2. In these Regulations:

"animal remedy" has the meaning assigned to it in the Animal Remedies Act, 1956 (No. 41 of 1956);

"imported" means brought by any means into the State from outside the State and "importation" shall be construed accordingly;

"manufacture" includes processing, compounding, formulating, filling, packaging and labelling;

"pharmacist" means a registered pharmaceutical chemist, a registered dispensing chemist and druggist, or a registered druggist;

"sale by wholesale" means sale or supply to a person for the purpose of resale.

3. These Regulations shall not apply to the preparation of an animal remedy--

( a ) by a registered veterinary surgeon for supply 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 had consulted him in the course of his private professional practice, or

( b ) by or under the supervision of a pharmacist in accordance with a prescription given by a registered veterinary surgeon, or

( c ) on a premises by or under the supervision of a pharmacist for the purpose of retail sale exclusively on these premises otherwise than in accordance with a prescription mentioned in paragraph (b) of this Regulation, or

( d ) on premises not exceeding three in number, by or under the supervision of a pharmacist for the purpose of maintaining a stock of an animal remedy for dispensing exclusively on any of these premises as mentioned in paragraphs (b) or (c) of this Regulation, or

( e ) by or under the supervision of a person in charge of a laboratory which is engaged in recognised pharmaceutical or veterinary education, research or analysis and is used for such purposes in such a laboratory.

4. Any person who engages in or proposes to engage in the manufacture, importation or sale by wholesale, of an animal remedy or animal remedies shall furnish to the Secretary of the Department of Agriculture the following particulars in regard to such manufacturing, importing or wholesaling operation--

( a ) the name and address of the manufacturer, importer or wholesaler;

( b ) in the case of a company, the address of the registered office;

( c ) the address of the premises at which the business of manufacture, importation or sale by wholesale is carried on;

( d ) the names and active principles of the products being manufactured, imported or sold by wholesale.

5. The Minister may require any manufacturer, importer or wholesaler to furnish additional information about any animal remedy being manufactured, imported or sold by wholesale by him.

6. (1) Every manufacturer, importer or wholesaler who is carrying on business on the date on which these Regulations come into force shall, within two calendar months of that date, furnish to the Secretary of the Department of Agriculture the particulars required to be furnished pursuant to Regulation 4 of these Regulations.

(2) Every person who proposes to engage in the manufacture, importation or sale by wholesale of animal remedies shall, before commencing to manufacture, import or sell by wholesale, as the case may be, furnish to the Secretary of the Department of Agriculture the particulars required to be furnished pursuant to Regulation 4 of these Regulations.

GIVEN under my Official Seal, this 16th day of April, 1980.

RAY MacSHARRY,

Minister for Agriculture.

EXPLANATORY NOTE.

These Regulations require manufacturers, importers and wholesalers of animal remedies to register with the Department of Agriculture.