Since March 2024, supranational rules for the circulation of veterinary medicinal products have been officially in effect within the Eurasian Economic Union (EAEU). Although the process has launched, the market is only just beginning to realize the scale of the work ahead. Anna Babushkina, Deputy Head of the Department for State Veterinary Supervision at Rosselkhoznadzor, explained why the transition deadline is planned to be extended to 2030 and what difficulties arise when preparing registration dossiers.
Decision to Extend: 2030 as the “Cut-off Point”
The originally established deadline (2027) was under threat due to the slow preparation of the market and the lack of readiness of administrative infrastructure in a number of countries. Currently, a third package of amendments to the EAEU rules is under consideration, proposing to extend the transition period until December 31, 2030.
As noted by Anna Babushkina in an interview with “Veterinary Medicine and Life”, the initiator of postponing the dates was Belarus, with support from Kazakhstan. These countries have not yet established systems for duties, mutual settlements, and payments. The extension will give businesses additional time, but the regulator emphasizes the irreversible consequences of missing the deadline.
“If the transition period ends on December 31, 2030, then from January 1, 2031, such drugs will not be included in the unified registry and will not be able to circulate in any of the Union countries. We are talking about a complete cessation of circulation within the EAEU space.”
— Anna Babushkina, Deputy Head of the Dept. for State Veterinary Supervision, Rosselkhoznadzor
Pharmacokinetics and “Old” Dossiers
The greatest difficulty in forming a dossier is caused by pharmacokinetics data. For drugs registered before 2015, old reports are considered irrelevant, as the research methods of that time no longer meet modern standards. This applies to pharmacotherapeutic drugs, antibiotics, and coccidiostats—new reports must be prepared for them.
For drugs that have been circulating on the Russian market for more than 10 years, a relaxation is provided: instead of new efficacy tests, it is permissible to submit properly executed reports and acts on use in farms, as well as an up-to-date five-year pharmacovigilance report.
Status of New Drugs and Payments
An important nuance concerns products released to the market after March 13, 2024. At the current stage, the single market for them is not yet fully functional.
“New drugs can currently only circulate in the country where they are registered. That is, registration in Russia does not automatically grant the right to sell in Kazakhstan, Belarus, or other Union countries. This is a fundamental point that is important for business to consider when bringing new products to market.”
— Anna Babushkina, Deputy Head of the Dept. for State Veterinary Supervision, Rosselkhoznadzor
Regarding duties, Rosselkhoznadzor has already posted details for the Russian Federation on its website. Data for other Union countries will be accumulated on the resources of the Eurasian Economic Commission (EEC).
Regulator’s Verdict
Businesses are advised to analyze their portfolio now and identify the most in-demand drugs for priority research and submission of materials. The regulator urges not to put off work until the end of 2030 and to avoid attempts to submit all dossiers simultaneously.
“The regulator and expert organizations have limited human and time resources. We count on a steady submission of materials so that the process proceeds without overloads and disruptions.”
— Anna Babushkina, Deputy Head of the Dept. for State Veterinary Supervision, Rosselkhoznadzor
