This Decree, in application of the Animal Act of 2011 in its last amended version, defines: application of a veterinary medicinal product; pharmacists; packaging and labelling of medicinal products; adverse reaction in an animal; side effect in humans; concentration of the veterinary medicinal product; veterinary medicinal product of a biological nature; veterinary pharmacovigilance; trade in veterinary medicines; risks associated with the veterinary application; production of an animal feed with a medicinal effect. The Decree provides for: marketing authorisation for a veterinary medicinal product, including: requested documents, compliance with European legislation, ground for refusing the issuance of a licence, specific requirements related to consumer safety and animal health and welfare in case of veterinary medicinal products placed on the market for one or more animal species intended for food production, measures concerning residues, specific grounds for refusal in relation to equine animals.
Further matters covered by the Decree include: simplified application authorisation for homeopathic veterinary medicinal products; application for a license for a generic veterinary medicinal product of a biological nature; application for a parallel import permit; exemptions in case of serious epizootic diseases; exemptions for veterinary medicines for specific animal species including: aquarium fish, small rodents, cage birds, ferrets and rabbits not kept for animal products; veterinary medicinal products based on radioactive isotope; veterinary qualification; general requirements for manufacturing animal feed with a medicinal effect; good manufacturing practices.