On 4 February 2021, the Ukrainian Parliament passed a new comprehensive law on veterinary medicine (the "Law"). The Law significantly changes requirements to the approval of, and operations with, veterinary medicinal products ("VMPs").
In addition to manufacturing that already requires a license in Ukraine, the following types of business operations with VMPs shall be subject to licensing: import, wholesale dealing, retail trade. Holders of manufacturing and import licenses will need to ensure the services of a qualified person (QP) are continuously available.
State registration (marketing authorization)
Marketing authorizations ("MA") for VMPs shall now be issued for an indefinite period, as different from the current system that requires MA renewal every 5 years.
MA application may only be submitted by a local legal entity. If registration dossier is owned by a non-resident company, it would need to engage an authorized representative in Ukraine (being either its local subsidiary or a third-party entity authorized by contract) for authorization purposes.
MA holder shall pay an annual mandatory fee for post-authorization monitoring of each of its veterinary medicines. The amount of fee shall be equal to 1 minimum wage established in Ukraine as of 1 January of respective year (currently UAH 6,000).
The Law establishes separate rules for different types of MA applications (generic, hybrid, combination, homeopathic etc.).
The Law introduces measures to reduce usage of veterinary antimicrobials. Among other things, it provides for additional requirements to their state registration and prescribing.
The Law sets out requirements to advertising and promotion of VMPs, in many aspects similar to the ones existing for human medicines. However, there are important differences. For instance, while sampling of human medicines is fully prohibited, the Law permits limited sampling of VMPs (other than prescription-only) to veterinary professionals.
Local clinical trials of VMPs will now require an approval of competent Ukrainian authority and shall be conducted in line with VICH Good Clinical Practice.
In line with the approaches implemented in the EU, the Law establishes regulatory data protection for technical documentation relating to VMPs. Data protection periods will range from 10 to 18 years, depending on the type of medicinal product. Protection periods will be twice shorter for products registered during the first 5 years of the Law being operational.
The Law needs to be signed by the President of Ukraine and officially promulgated to enter into force. Majority of its provisions will become operational in 2 years, by which time relevant subordinate regulations would have to be developed and approved. Transition periods will be available for existing market participants to adjust to new requirements.
For further information, please contact Asters' Counsel Viktoriya Podvorchanska