The Law revises the procedure for marketing authorisation of veterinary medicinal products, including updated dossier requirements, lifecycle regulation and post-authorisation obligations.
\nTransitional rule: veterinary medicinal products authorised under the previous legislation may continue to be manufactured, commercialised and used for up to five years, subject to compliance with certain conditions.<\/p>\n
This transition period is intended to ensure market continuity while gradually transitioning products to the new regulatory framework. The subordinate legislation on marketing authorisation has not yet been adopted.<\/p>\n
Mandatory localisation of the marketing authorisation holder<\/strong><\/p>\n The Law requires that the marketing authorisation holder (MAH<\/strong>) must be a legal entity established in Ukraine.<\/p>\n As a result:<\/p>\n This point is relevant for international animal health companies assessing market entry models ahead of the reform.<\/p>\n Expanded licensing framework across the supply chain<\/strong><\/p>\n Only the manufacturing of veterinary medicinal products is subject to licensing. The Law introduces separate mandatory licences for:<\/p>\n Key timelines:<\/p>\n This staggered approach gives market operators additional time to adapt operationally and structurally. The subordinate legislation and licensing conditions have not yet been adopted.<\/p>\n GxP compliance becomes the cornerstone of market access<\/strong><\/p>\n The Law formally embeds GxP standards as the foundation of regulatory compliance across the veterinary medicines lifecycle:<\/p>\n GMP compliance and certification will become a central prerequisite for market entry. The subordinate legislation on GxP has not yet been adopted.<\/p>\n Mandatory laboratory control of imported veterinary medicines<\/strong><\/p>\n As a general rule, laboratory quality control of imported veterinary medicinal products will be mandatory.<\/p>\n There is a temporary exemption. Until 1 July 2027<\/strong>, imports may be exempt where the relevant batches have already undergone laboratory control in PIC\/S member countries.<\/p>\n Introduction of a pharmacovigilance system<\/strong><\/p>\n The Law establishes a statutory pharmacovigilance framework for veterinary medicinal products, which will become fully applicable from 1 July 2027.<\/p>\n MAHs and other market operators will be required to implement systems for:<\/p>\n Regulatory data exclusivity for veterinary medicines<\/strong><\/p>\n For the first time, Ukrainian law introduces regulatory data exclusivity for veterinary medicinal products.<\/p>\n The duration and scope of protection will depend on:<\/p>\n This is a strategically important development for innovative and originator products.<\/p>\n Introduction of an annual fee for the maintenance of marketing authorisations<\/strong><\/p>\n MAHs will be required to pay an annual fee equal to 0.5 times the minimum monthly wage (currently around EUR 86) for each valid marketing authorisation.<\/p>\n Currently, there is no clarity on whether the fee applies:<\/p>\n Definition of falsified veterinary medicinal products aligned with EU law<\/strong><\/p>\n The Law introduces a definition of falsified veterinary medicinal products, closely aligned with EU legislation.<\/p>\n There is, however, a caveat. Unlike human medicines, Ukrainian criminal law does not currently provide a dedicated offence for falsification or commercialisation of falsified veterinary medicinal products. In practice, enforcement remains limited primarily to trademark-related offences, pending further criminal-law amendments.<\/p>\n New statutory framework for advertising of veterinary medicinal products<\/strong><\/p>\n A new Article 21-1 is added to the Law of Ukraine on Advertising, establishing a dedicated legal regime for advertising of veterinary medicinal products and medicated feed.<\/p>\n In brief, the new rules provide that:<\/p>\n While the advertising framework mirrors concepts familiar from human medicines regulation, it introduces new compliance risks for animal health companies active in Ukraine.<\/p>\n What this means for global market players<\/strong><\/p>\n The reform requires early strategic planning. In particular, international companies should:<\/p>\n\n
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