Ukraine signs long-awaited overhaul of veterinary medicines legislation

On 20 January 2026, the President of Ukraine signed into law long-anticipated amendments to the Law on Veterinary Medicines and Animal Welfare (Draft Law No. 12285-d).

The reform represents a systemic shift of the Ukrainian veterinary medicines framework towards EU-aligned regulation, broadly reflecting the approach of Regulation (EU) 2019/6. The new legislation will enter into force on 1 March 2026 with extended transitional periods applying to marketing authorisations, licensing, GxP compliance, pharmacovigilance and advertising.

The following article highlights the key changes introduced by the Law.

New marketing authorisation (MA) regime for veterinary medicinal products

The Law revises the procedure for marketing authorisation of veterinary medicinal products, including updated dossier requirements, lifecycle regulation and post-authorisation obligations.
Transitional 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.

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.

Mandatory localisation of the marketing authorisation holder

The Law requires that the marketing authorisation holder (MAH) must be a legal entity established in Ukraine.

As a result:

• All new marketing authorisations issued after 1 March 2026 will require a Ukrainian legal entity to act as the MAH.
• Foreign manufacturers must rely on a local subsidiary or an appointed Ukrainian MAH structure.

This point is relevant for international animal health companies assessing market entry models ahead of the reform.

Expanded licensing framework across the supply chain

Only the manufacturing of veterinary medicinal products is subject to licensing. The Law introduces separate mandatory licences for:

• manufacturing and imports;
• wholesale distribution of veterinary medicines and API; and
• retail sale of vet medicines.

Key timelines:

• Manufacturing and imports, and wholesale licences: mandatory from 1 September 2027.
• Retail licences: mandatory from 1 March 2028.

This staggered approach gives market operators additional time to adapt operationally and structurally. The subordinate legislation and licensing conditions have not yet been adopted.

GxP compliance becomes the cornerstone of market access

The Law formally embeds GxP standards as the foundation of regulatory compliance across the veterinary medicines lifecycle:

• GCP – for clinical trials;
• GMP – for manufacturers and importers;
• GDP – for wholesalers and API suppliers;
• GLP – for laboratories.

GMP compliance and certification will become a central prerequisite for market entry. The subordinate legislation on GxP has not yet been adopted.

Mandatory laboratory control of imported veterinary medicines

As a general rule, laboratory quality control of imported veterinary medicinal products will be mandatory.

There is a temporary exemption. Until 1 July 2027, imports may be exempt where the relevant batches have already undergone laboratory control in PIC/S member countries.

Introduction of a pharmacovigilance system

The Law establishes a statutory pharmacovigilance framework for veterinary medicinal products, which will become fully applicable from 1 July 2027.

MAHs and other market operators will be required to implement systems for:

• monitoring adverse reactions;
• reporting safety data; and
• cooperating with the competent authorities.

Regulatory data exclusivity for veterinary medicines

For the first time, Ukrainian law introduces regulatory data exclusivity for veterinary medicinal products.

The duration and scope of protection will depend on:

• the type of product; and
• the target animal species.

This is a strategically important development for innovative and originator products.

Introduction of an annual fee for the maintenance of marketing authorisations

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.

Currently, there is no clarity on whether the fee applies:

• only to new veterinary medicines registered under the Law;
• or also to all previously issued marketing authorisations.

Definition of falsified veterinary medicinal products aligned with EU law

The Law introduces a definition of falsified veterinary medicinal products, closely aligned with EU legislation.

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.

New statutory framework for advertising of veterinary medicinal products

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.

In brief, the new rules provide that:

• advertising is permitted only after marketing authorisation of the product (where required);
• advertising must be accurate, non-misleading and consistent with the product’s summary of characteristics;
• advertising of prescription-only veterinary medicines is generally prohibited, except where addressed exclusively to veterinary professionals and/or market operators;
• advertising of antimicrobial veterinary medicinal products via samples is prohibited;
• advertising of autogenous immunological veterinary medicines is fully prohibited;
• distribution of samples is strictly limited and subject to detailed conditions.

While the advertising framework mirrors concepts familiar from human medicines regulation, it introduces new compliance risks for animal health companies active in Ukraine.

What this means for global market players

The reform requires early strategic planning. In particular, international companies should:

• reassess the MAH and localisation structures;
• map licensing gaps across supply chains, ensure proper contractual framework between MAHs, manufacturers and importers;
• prepare for GMP/GDP alignment and inspections, and compliance with local pharmacovigilance requirements;
• review legacy portfolios under the five-year transition;
• update promotional and compliance policies for veterinary medicines. 

For more information and assistance across the full spectrum of regulatory, licensing and compliance matters in Ukraine, contact your CMS client partner or the CMS experts: Borys Danevych.