Business calls for recognition of EU veterinary GMP certificates and batch testing results for veterinary medicinal products

28/ 04/ 2026

Member companies of the European Business Association warn of significant risks to the veterinary medicinal products market if the principles of European regulatory practice are not taken into account in the course of updating legislation. In particular, this concerns the need for official recognition of Good Manufacturing Practice (GMP) certificates issued in EU countries and in states with stringent regulatory authorities (SRAs). Without such recognition, manufacturers may face duplication of inspections, delays in product supply, and increased costs. At the same time, it should be noted that Ukraine currently lacks clearly defined and fully implemented GMP requirements in the field of veterinary medicinal product manufacturing. Under such conditions, the introduction of mandatory national inspections without an appropriate regulatory framework may create additional legal uncertainty for businesses and complicate market access. Equally important is the issue of recognising the results of batch testing of veterinary medicinal products imported into Ukraine. The requirement for repeated full qualitative and quantitative testing of each batch in accredited Ukrainian laboratories may lead to delays in bringing products to market, risks of shortages, and reduced access to high-quality and safe medicines. The business community emphasises that the proposed changes would help avoid excessive regulatory burden. In particular, this includes recognising GMP certificates issued by competent EU and SRA authorities without additional inspections in Ukraine, as well as allowing the use of test results obtained at certified manufacturing sites without repeated testing. Experts underline that the implementation of these approaches is critical to ensuring stable supply of veterinary medicinal products, maintaining competition, and protecting consumer interests. These issues are particularly relevant in the context of the ongoing revision of sector-specific legislation in veterinary medicine, aimed at harmonising Ukrainian regulations with EU law. At this stage, it is crucial to establish approaches that prevent duplication of regulatory procedures and ensure the effective functioning of the veterinary medicines market in Ukraine. The Animal Health Committee of the European Business Association has already submitted relevant proposals to the draft legislative amendments, developed jointly with companies and with the involvement of legal experts.

In particular, this concerns the need for official recognition of Good Manufacturing Practice (GMP) certificates issued in EU countries and in states with stringent regulatory authorities (SRAs). Without such recognition, manufacturers may face duplication of inspections, delays in product supply, and increased costs.

At the same time, it should be noted that Ukraine currently lacks clearly defined and fully implemented GMP requirements in the field of veterinary medicinal product manufacturing. Under such conditions, the introduction of mandatory national inspections without an appropriate regulatory framework may create additional legal uncertainty for businesses and complicate market access.

Equally important is the issue of recognising the results of batch testing of veterinary medicinal products imported into Ukraine. The requirement for repeated full qualitative and quantitative testing of each batch in accredited Ukrainian laboratories may lead to delays in bringing products to market, risks of shortages, and reduced access to high-quality and safe medicines.

The business community emphasises that the proposed changes would help avoid excessive regulatory burden. In particular, this includes recognising GMP certificates issued by competent EU and SRA authorities without additional inspections in Ukraine, as well as allowing the use of test results obtained at certified manufacturing sites without repeated testing.

Experts underline that the implementation of these approaches is critical to ensuring stable supply of veterinary medicinal products, maintaining competition, and protecting consumer interests.

These issues are particularly relevant in the context of the ongoing revision of sector-specific legislation in veterinary medicine, aimed at harmonising Ukrainian regulations with EU law. At this stage, it is crucial to establish approaches that prevent duplication of regulatory procedures and ensure the effective functioning of the veterinary medicines market in Ukraine.

The Animal Health Committee of the European Business Association has already submitted relevant proposals to the draft legislative amendments, developed jointly with companies and with the involvement of legal experts.