Decree No. 1349 of the Cabinet of Ministers validating the Regulation on the registration of veterinary drugs, animal feed additives, premixes and ready-made animal feedstuffs.

This Regulation establishes the mechanism for state registration of veterinary drugs, animal feed additives, premixes and ready-made animal feedstuffs. Registration shall be performed by the State Committee on Veterinary Medicine on the basis of application filed by the owner of the registration dossier or his legal representative, the decision of the State Pharmacological Commission on Veterinary Medicine and expert opinion of the National Agency on Veterinary Drugs and Animal Feed Additives and the National Agency for Veterinary Immunobiological Preparations. The owner of the registration dossier is a legal entity that provides collection and processing of information on all cases of negative reactions to a veterinary drug. In the process of registration of the national veterinary immunobiological formulation the applicant must deposit strains (cultures) of microorganisms used in production and control of such a preparation, at the National Center for strains of microorganisms. Registration of drugs that may worsen veterinary, sanitary and epizootic conditions or cause damage to human health or animal health shall be prohibited. For the examination of the registration dossier and the registration of a preparation, the applicant submits an application to the authorized agency related to the examination of the drug together with the registration dossier. Simplified drug registration procedure applies to drugs that have a high similarity, contain an equal amount of equally active substances of the same form, the results of the corresponding whose research confirms their identity with regard to bioavailability and bioequivalence, as well as the fact that their therapeutic effect is essentially the same with the therapeutic effect of the patented drugs, registered in Ukraine and other countries, as well as for the drugs prescribed by the State Committee on Veterinary Medicine as such have the same criteria for registration.