Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. No. 3142 of 1994).

These Regulations implement Council Directive 93/40/EEC, which is the latest in a series of amendments to Council Directive 81/851/EEC. They provide for veterinary medicinal products to be placed on the market subject to marketing authorizations rather than the previous system of product licences. These authorizations may be granted either by the Ministers or, in accordance with Council Regulation 2309/93/EEC, by the European Agency for the Evaluation of Medicinal Products (reg. 3). They provide for the form and manner of an application, and the terms on which the Ministers may grant an authorization (regs. 4 and 5 and Schedules 1 and 2). They place duties on persons responsible for placing products on the market (reg. 6), on person where a product is manufactured outside the EEA (reg. 7) and on an importer who holds a marketing authorization (reg. 8). There are provisions for the variation, renewal, suspension and refusal of an authorization (regs. 9 to 13 and Schedule 3), provisions as to confidentiality (reg. 14) and fees (reg. 15). Breach of the regulations is an offence under regulation 16, with a defence in regulation 17.