EBA сalls for approval of procedure for updating registration dossiers for veterinary medicinal products

26/ 10/ 2026

Listen to online Stop   The European Business Association calls for the prompt approval of a procedure for updating registration dossiers for veterinary medicinal products registered in Ukraine under previous legislation. The absence of clear rules creates legal uncertainty for companies that are required to keep their products’ registration documentation up to date. Under Law No. 1206-IX on Veterinary Medicine and Animal Welfare, veterinary medicinal products registered under previous legislation and covered by valid registration certificates when the Law entered into force may be manufactured, imported into Ukraine and placed on the market for five years. The transitional period runs until 1 March 2031. At the same time, registration certificate holders are required to keep the information contained in their registration dossiers up to date. However, without an approved procedure, companies lack clear rules on how to update their documentation during the transitional period. This issue is also relevant to biocidal products for veterinary use, including insecticides, acaricides and ectoparasiticides used to control pests and disease vectors in livestock facilities. As Ukrainian legislation is harmonised with EU law, some of these products fall outside the scope of the new veterinary medicinal product registration procedure. Meanwhile, legislation governing biocidal products is still being developed. This makes it difficult to determine the requirements for updating the relevant registration documentation. The Association emphasises that approving a procedure for updating registration dossiers is essential to establishing clear and predictable rules for businesses, while ensuring the uninterrupted availability on the market of veterinary medicinal products and other products essential for maintaining biosecurity in livestock farming.

The European Business Association calls for the prompt approval of a procedure for updating registration dossiers for veterinary medicinal products registered in Ukraine under previous legislation. The absence of clear rules creates legal uncertainty for companies that are required to keep their products’ registration documentation up to date.

Under Law No. 1206-IX on Veterinary Medicine and Animal Welfare, veterinary medicinal products registered under previous legislation and covered by valid registration certificates when the Law entered into force may be manufactured, imported into Ukraine and placed on the market for five years. The transitional period runs until 1 March 2031.

At the same time, registration certificate holders are required to keep the information contained in their registration dossiers up to date. However, without an approved procedure, companies lack clear rules on how to update their documentation during the transitional period.

This issue is also relevant to biocidal products for veterinary use, including insecticides, acaricides and ectoparasiticides used to control pests and disease vectors in livestock facilities. As Ukrainian legislation is harmonised with EU law, some of these products fall outside the scope of the new veterinary medicinal product registration procedure. Meanwhile, legislation governing biocidal products is still being developed. This makes it difficult to determine the requirements for updating the relevant registration documentation.

The Association emphasises that approving a procedure for updating registration dossiers is essential to establishing clear and predictable rules for businesses, while ensuring the uninterrupted availability on the market of veterinary medicinal products and other products essential for maintaining biosecurity in livestock farming.