Veterinary medicines

Draft Resolution of the Cabinet of Ministers of Ukraine "On approval of the Regulation on state registration of veterinary medicinal products". Language(s): Ukrainian. Number of pages: 27

The draft Resolution is developed in accordance with part four and part ten of Article 54 of the Law of Ukraine of 4 February 2021 No. 1206 "On Veterinary Medicine" that establishes new requirements for state registration of veterinary medicinal products.

Today, the basis for the circulation of medicines in most countries is state registration, which is a prerequisite for the placement of medicinal product on the market legally. The purpose of such registration is to provide the manufacturer with information allowing to evaluate the benefit/risk balance for each product in order to resolve the issue of its admission into circulation.

The draft Resolution provides for the approval of the Regulation on state registration of veterinary medicinal products. The state registration procedure provides for scientific evaluation of a veterinary medicinal product by the National Institute of Veterinary Medicine of Ukraine. Services for the scientific evaluation of a veterinary medicinal product are chargeable. The objective of the draft Resolution is to define the procedure for state registration of veterinary medicinal products and to implement the requirements of EU legislation into Ukrainian legislation.