On March 21, 2023, the new Law of Ukraine on Veterinary Medicine (the law) comes into force subject to the transitional provisions listed below. The law aims to bring Ukrainian veterinary law into line with EU directives and regulations in the context of fulfilling the obligations of the EU-Ukraine Association Agreement.
The law establishes a comprehensive legal framework for veterinary medicine, animal health and welfare, veterinary practices and the use of veterinary medicinal products. It defines the system of governance and the functions of the regulatory authorities, as well as the principles for the development, approval, review and application of veterinary measures such as measures to control animal diseases, defines the criteria for inspections, tests, certifications, etc.
In this article we discuss the main innovations in the Law on the Movement of Veterinary Medicinal Products.
Holder of the registration certificate (placing on the market)
Only legal persons (dossier owners) based in Ukraine can apply for and receive registration certificates (marketing authorization). If the dossier holder is a foreign legal person, he must appoint an official representative in Ukraine: either a local subsidiary or an authorized third party. If the foreign dossier holder engages a third party, the agreement must contain the following:
- the procedure and conditions for submitting the dossier for the purpose of registration (approval);
- the liability of the official representative for the disclosure or unauthorized use of the information in the dossier;
- the conditions and procedure for interactions between the parties after a veterinary medicinal product has been authorized.
Within five years, the law allows the import and circulation of veterinary medicinal products that were authorized under the previous legal framework. In addition, the renewal of veterinary medicinal products that were authorized before the law came into force will be made possible by submitting additional data in order to comply with the new requirements of the law.
Release and dissemination of veterinary drugs
Until now, only the production of veterinary drugs was subject to approval. The new law provides for a license requirement for all activities related to the movement of veterinary medicinal products: manufacture, import, wholesale and retail.
A manufacturing license is required for complete manufacturing as well as all manufacturing steps including processing, assembly, packaging, repackaging, labeling, relabelling, storage, sterilization, testing and batch release.
A license is also required for the import of veterinary medicinal products. Manufacturers and importers must hire a qualified person, either by employment or by contract.
The Qualified Person must ensure that each batch of veterinary medicinal product:
(a) (if made in Ukraine) was manufactured in accordance with GMP and verified through tests according to the requirements of the dossier
(b) (for imports into Ukraine) complete qualitative testing of all active ingredients and other control tests that are necessary to ensure the quality of the veterinary medicinal products required in the dossier
Detailed requirements for qualified persons are specified in subordinate legal provisions.
The manufacturing and import licenses enable veterinary medicinal products to be sold to wholesale license holders. A wholesale license in turn allows veterinary medicinal products to be sold to other wholesalers as well as to retailers and veterinarians / hospitals. A retail license allows veterinary drugs to be sold to consumers.
Distance selling (online) of veterinary medicines
The law allows licensed retailers to remotely sell veterinary medicines in accordance with e-commerce laws. Distance selling of Rx drugs is prohibited. The law has special requirements for websites that offer veterinary medicines for sale online.
Regulatory data exclusivity
The law provides for the protection of the regulatory data contained in the dossier for novel veterinary medicinal products.
The holder of a marketing authorization for a novel medicinal product enjoys exclusivity for 10 to 18 years, depending on the type of medicinal product:
(a) 10 years for veterinary medicinal products for cattle, meat sheep, pigs, chickens, cats and dogs;
(b) 14 years for antimicrobial veterinary medicinal products for cattle, meat sheep, pigs, chickens, dogs and cats that contain antimicrobial agents not used in previously authorized veterinary medicinal products;
(c) 18 years for veterinary medicinal products for bees;
(d) 14 years for veterinary medicinal products intended for other animal species.
The data exclusivity provisions are subject to a transitional period: The exclusivity period for novel drugs that are submitted for approval in the first five years after the law comes into force is half of the above periods.
The law lays down requirements for conducting clinical studies with veterinary medicinal products.
Any attempt requires the approval of the State Service of Ukraine for Food Safety and Consumer Protection and is subject to compliance with VICH requirements in terms of planning, implementation and documentation.
The law lays down the following specific requirements for the advertising of veterinary medicinal products and medicated feed:
(1) Only approved veterinary medicinal products may be advertised in Ukraine;
(2) Public advertising of Rx drugs is prohibited. Advertisements for Rx veterinary medicinal products can only target:
(b) Market participants in veterinary medicinal products who are active in wholesaling and retailing, and
(c) Operator of animal husbandry facilities (only for immunobiological veterinary drugs, e.g. vaccines).
(3) Sampling of Rx drugs is prohibited. The law allows the distribution of samples of OTC drugs with appropriate labeling:
(a) Exclusively and directly to veterinary professionals at events sponsored by the distributor of such samples or when visiting sales representatives, and
(b) in the amount that does not exceed a treatment cycle specified in the package insert.
The law introduces a national system of veterinary pharmacovigilance to ensure the collection and analysis of data on undesirable and unexpected reactions from veterinary medicinal products.
The marketing authorization holder must set up a pharmacovigilance system and appoint a qualified person. A description of the pharmacovigilance system must be provided as part of the registration dossier (marketing authorization). The marketing authorization holder must report all adverse reactions by submitting the relevant data to the veterinary pharmacovigilance database.
Veterinarians will report to the competent authority and the MAHs of any adverse reactions they may experience.
Transitional provisions and measures
The law comes into force on March 23, 2023.
The designated regulatory authority sets the deadlines for the entry into force of the GMP and GDP requirements as well as the requirements for retail practices.
The manufacturing permits issued under previous law are valid for one year from the entry into force of the law. License holders can apply for new licenses to be issued free of charge during this first year.
Obtaining import, wholesale and retail licenses and compliance with the respective admission requirements are voluntary for one year after the law has come into force.
The international animal health industry operating in Ukraine regards the passage of the law as a positive development. When the law is fully enacted, Ukraine’s legal framework for veterinary medicinal products will become compatible with the EU’s legal framework.
The Ukrainian government is currently developing a subsidiary law that is expected to be passed by March 23, 2022.