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.
The draft Resolution provides for approval of the Regulation on state registration of veterinary medicinal products that defines, in particular:
• procedure for state registration of veterinary medicinal products;
• requirements for the application for state registration, registration dossier and other documents submitted for state registration of veterinary medicinal products;
• requirements for tests necessary for state registration of veterinary medicinal products;
• specifics of state registration of certain types of veterinary medicinal products;
• the procedure for granting permission for the production, import and use of unregistered veterinary medicinal products for scientific research (testing);
• the procedure for payment for post-registration monitoring.
The draft Resolution aims to bring Ukrainian legislation in terms of registration of veterinary medicinal products in line with EU requirements.
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