EAEU Extends Veterinary Drug Registration Deadline to 2030 to Avert Market Shortages

The Council of the Eurasian Economic Commission (EEC) has approved significant amendments to the regulations governing veterinary medicines within the Eurasian Economic Union (EAEU). The most critical change is the extension of the transition period for unified registration until December 31, 2030.

Under these updated rules, veterinary drugs registered according to the national laws of individual EAEU member states can continue to circulate across the entire customs union territory until the end of 2030. Furthermore, the option to register new products under national legislation—valid only within the territory of the specific registering state—will remain available throughout this extended period.

Industry experts anticipated this decision, noting that as of late 2025, a vast majority of products on the market were still registered under national rather than union-wide procedures. Forcing a sudden transition could have led to widespread product shortages and supply chain disruptions.

GMP Certificate Mutual Recognition

The amendments also address a long-standing grievance for international pharmaceutical companies: the mutual recognition of Good Manufacturing Practice (GMP) certificates. The new norms establish that GMP certificates issued by any of the five EAEU member states for production sites located in third countries (outside the union) must be recognized by all members.

Previously, international manufacturers often faced the burden of redundant inspections, as recognition was primarily guaranteed only for local EAEU producers. This update is designed to simplify logistics, lower costs for importers, and reduce the administrative workload on national regulatory bodies.

Persistent Market Barriers

Despite the push for a harmonized market, practical obstacles remain. While the legal framework for a unified market exists, individual nations continue to exercise strict domestic oversight. For example, Russia’s federal regulator, Rosselkhoznadzor, frequently adds medications from Kazakhstan and Belarus to internal blacklists, citing non-compliance with Russian safety standards.

Additional Regulatory Updates

The EEC has also been tasked with creating a comprehensive list of reference veterinary drugs during the transition period. This list will be updated as necessary to provide a clearer framework for manufacturers of generic and biosimilar products.

By extending deadlines and refining technical requirements, the commission aims to systematize the regional pharmaceutical market while reducing the financial and administrative pressure on manufacturers and regulators alike.

Source: eec.eaeunion.org