This Decree implements provisions of the Veterinary Drugs Act and the Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products. It contains rules relative to the registration, production, packing, labelling, importation, exportation, transit and placing on the market of drugs intended for use in animals including fish. The 90 articles are divided into 8 Chapters.
As far as registration of animal drugs under the Act is concerned, the Decree makes provision for protection of registered data, duration and cancellation of registration, evaluation by the registration holder of production and control methods, communications by the holder to the Ministry, etc. The Decree lists exemptions from the prohibition to use non-registered drugs. The Decree further concerns permits for the production and placing on the market of, and trade in, animal drugs and lays down rules relating to production, packing, labelling, importation, exportation, transit and placing on the market of drugs.