On March 25, the text of EEC Council Decision No. 33 of February 24, 2026, was officially published. It approved the final third version of amendments to the Rules for Regulating the Circulation of Veterinary Medicines in the Customs Territory of the EAEU (EEC Council Decision No. 1 of January 21, 2022). The document will enter into force 30 days after publication – on April 24, 2026. Although the market focused on extending transition periods, a significant portion of the document is devoted to revising the Rules for conducting pharmaceutical inspections.
New application form and significant revision of the CAPA procedure
The document approves an updated GMP inspection application form. But the most important and significant change for manufacturers is a completely redesigned procedure for implementing corrective and preventive actions (CAPA) after identifying nonconformities.
The algorithm has now been changed: the manufacturer is required to first submit a draft CAPA Plan to the regulator (within 30 days of receiving the inspection report), await its official approval, and only then begin actual corrective actions. Due to this significant change, the time for actual CAPA Plan implementation and the submission of the Report and evidence has been reduced – a strict time limit of 60 calendar days has been set from the date of Plan approval.
Extension of the transition period until 2030
The key point lobbied for by marketing authorization (MA) holders remains unchanged: the transition period has been extended for another three years, until December 31, 2030. This gives companies additional time to gradually bring their dossiers into full compliance with EAEU requirements without disrupting supply chains.
Other important changes:
- Maintaining the geographic scope of MAs recognition. The ability to maintain the geographic scope of recognition for marketing authorizations amended after March 13, 2024, related to mandatory requirements (e.g., digital labeling or changes to dispensing status) has been established.
- Remote GMP inspections are permitted only in cases of force majeure. The format of remote inspections is officially established but strictly limited to cases where on-site inspector visits are physically impossible (emergency threats, man-made disasters, epidemics, or force majeure circumstances threatening the lives of inspectors). Moreover, the Rules strictly stipulate that once the force majeure circumstances have been eliminated, the next scheduled inspection must be an on-site inspection.
- Circulation of “Union” medicines. The provisions of paragraphs 102 and 208 of the Rules have been clarified: veterinary medicines that have already been registered in accordance with EAEU Rules or whose dossiers have been brought into compliance with Union requirements may be circulated without hindrance until their expiration date.
What does this mean for companies?
In practical terms, the following tasks are paramount for 2026:
- Systematic restructuring of internal processes for preparing for GMP inspections, considering the significant reduction in the time required to implement CAPA Plans (up to 60 days) and the need for their prior approval.
- Portfolio inventory, dividing into national and “Union” MAs.
- Verification of the dossier status and assessment of the impact of changes made after March 13, 2024, on the geographic scope of recognition.
- Risk assessment and preparation for complex GMP inspection formats, considering strict restrictions on remote work for sites in foreign countries with complex logistics.
