Government Approves Regulations on State Registration of Veterinary Medicines
The Cabinet of Ministers of Ukraine has officially adopted a new regulation governing the state registration of veterinary medicinal products. This framework sets clear standards for registration procedures, labeling requirements, and the conditions under which registrations may be suspended, resumed, or canceled. The regulation incorporates key elements of European Union legislation, specifically Regulation (EU) 2019/6, reflecting Ukraine’s commitment to aligning its laws with EU norms as part of the Association Agreement and ongoing accession talks.
Registration Criteria and Conditions
The regulation outlines detailed requirements for:
- submission of registration applications;
- compilation of registration dossiers;
- inclusion of product leaflets;
- labeling standards for veterinary medicines.
Additionally, it defines procedures for suspending, restoring, or terminating state registrations. Transitional arrangements allow for the submission of documentation verifying manufacturing site compliance with good manufacturing practice (GMP) standards, including acceptance of paper-based documents during the adjustment period.
This legislative update marks a significant milestone in Ukraine’s efforts to fulfill its obligations under the EU Association Agreement. It also plays a crucial role in negotiations with the European Commission under Chapter 28, which covers consumer protection and health safeguards related to veterinary pharmaceuticals. The regulation was publicized through the Ministry of Economy and Environment’s website and reported on the Rubryka news platform.
By approving these regulations, Ukraine underscores its dedication to harmonizing national laws with European standards, advancing its integration with the European Union.
The new rules aim to enhance the quality and safety of veterinary medicinal products, which is expected to benefit animal health and, consequently, improve the safety of animal-derived food products in the country.
As the Ukrainian government takes steps to align its veterinary regulations with EU standards, similar legislative changes are unfolding in other sectors. Recently, the Ukrainian Parliament approved new tax regulations for small international parcels, showcasing the broader trend of regulatory reform aimed at enhancing compliance with international norms. This parallel development highlights the government's commitment to fostering a more integrated economic environment.