These Regulations provide for the control of the manufacture, placing on the market and administration of animal remedies in the sense of Community legislation here implemented. These remedies are also used for fish.
Control is carried out especially with a view of residues of such remedies in food. The Regulations introduce the requirement of an "animal remedies authorization" i.e. (a) a veterinary product authorisation within the meaning of Article 5 of Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products; (b) a licence granted under the Therapeutic Substances Act 1932 (No. 25 of 1932) in respect of an animal remedy named on the licence until the date of expiry of the licence; (c) a licence under Regulation 16, 17, 18(5), or 20; (d) a marketing authorisation granted under Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; (e) a registration granted by the Board in accordance with Regulation 8(2); or (f) such other document, registration, licence or authorization deemed by these Regulations to be an animal remedies authorization.