Ukraine Has Changed the Rules for Registering Veterinary Drugs

The Cabinet of Ministers of Ukraine has approved new rules for the state registration of veterinary drugs. These rules specify which documents manufacturers and applicants must submit, the requirements for product labeling and package inserts, and the circumstances under which registration may be suspended or terminated. Some of the new requirements will be phased in gradually, and the regulations themselves are aligned with European Union legislation.

 

The government has approved the Regulations on the State Registration of Veterinary Medicines. The document is intended to regulate the procedure by which such medicines receive state registration in Ukraine. This applies to medicines for animals that are manufactured in Ukraine or imported from other countries. By law, their production, sale, and use are generally permitted only after state registration, except in specific cases provided for by law.

The new rules specify what a registration application must contain. Separate requirements are set forth for the registration dossier and other documents submitted by the applicant. Rules for package inserts and the labeling of veterinary drugs are also outlined. This means that manufacturers will have clearer requirements regarding the information they must submit during registration and display on the product’s packaging.

The document also specifies what happens after an application is submitted. It sets forth the conditions for state registration, as well as the circumstances under which it may be suspended, resumed, or terminated. The registration decision itself must include the product name, manufacturer information, registration number, a brief description of the product, and any conditions or restrictions regarding its manufacture, sale, and use.

It is important to note that registration does not imply automatic approval for any drug. The law provides for the possibility of rejection, particularly if the submitted documents do not meet the established requirements or if the benefit-risk ratio for the drug is unfavorable. For drugs used in animals intended for food production, permissible limits for active ingredient residues must also be established.

The government has provided for a transition period for some of the new requirements. This applies, in particular, to documents confirming that manufacturing sites comply with good manufacturing practice requirements. Applicants will also be able to submit applications and other documents in paper form for a certain period of time. Transitional rules are also provided for certain requirements regarding good practices.

A separate set of new rules relates to European legislation. Ukraine is implementing the provisions of EU Regulation 2019/6, which establishes rules regarding veterinary medicinal products in the European Union. According to the government, this is part of Ukraine’s fulfillment of its obligations under the Association Agreement with the EU and the negotiation process regarding accession to the European Union.

The new rules are also significant for Ukraine’s ongoing negotiations with the European Commission. Specifically, they pertain to Chapter 28 of the negotiation process—“Consumer Protection and Public Health”—as it relates to veterinary medicines.

At the same time, the system of state registration of veterinary drugs is already provided for by Ukrainian legislation. The Law “On Veterinary Medicine and Animal Welfare” sets out general requirements for such registration and provides for the existence of the State Register of Veterinary Drugs. It is a public electronic registry containing information on registered products, refusals to register, suspensions and terminations of registration, as well as changes to its terms and conditions.

For certain drugs, the law provides for special procedures. For example, in certain cases, registration may be conducted on the basis of written authorization or scientific publications regarding active ingredients that have already been well studied. Under exceptional circumstances related to human or animal health, the submission of an incomplete registration dossier is permitted. In such a situation, the product may receive temporary registration, but additional conditions and controls are imposed on it.

Thus, the new resolution does more than simply establish a list of documents for manufacturers. It details the entire procedure for registering veterinary drugs—from submitting an application and dossier to labeling rules and the possible suspension of registration. The government notes that this should eliminate a legal loophole and ensure the full implementation of the law on veterinary medicine. This was reported by the Ministry of Agrarian Policy.

As of January 31, 2026, Ukraine has abolished the operation of veterinary businesses under the declarative principle. Licensing is now mandatory for the practice of veterinary medicine.