Veterinary Medicinal Products Regulations, 2004 (L.N. 469 of 2004).

In compliance with the European Community code relating to veterinary medicinal products laid down in Directive 2001/82/EC, the present Regulations establish particular provisions applicable to veterinary medicinal products destined to be placed on the market in the form of medicinal products, readymade veterinary medicinal products or premixes for medicated feedingstuffs. Title III (regs. 5-37) deals with marketing, for which an authorization issued by the Veterinary Services is compulsory. Title IV (regs. 38-50) concerns manufacture and imports. Title V (regs. 51-57) deals with labelling and package insert. Title VI (regs. 58-64) applies to the possession, wholesale distribution and dispensing of veterinary medicinal products. Title VII (regs. 65-71) provides for the setting up of a pharmocovigilance system. Title VIII (regs. 72-79) regards the inspections to be carried out by the Veterinary Services with a view to ensuring compliance with these Regulations, and sets out the sanctions to be applied in case of infringement. The Schedule attached concerns the requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal products.