The Eurasian Economic Commission's Council amended the Rules for Marketing Authorization and Expert Examination of Medicines for Human Use.

The amendments allow extending the provisions of the procedure for bringing marketing authorization applications in compliance with the EAEU requirements as optimized by the EEC Council’s Decision No. 34 dated May 22, 2025 to those manufacturers that applied before December 31, 2025 for the variation procedure in terms of adding recognizing States that were not specified previously. This ensures a prolonged validity of national marketing authorizations in these countries for the period of performing the procedures but not later than December 31, 2027.

"These amendments are designed to optimize the time frames for the procedures ensuring compliance with the EAEU requirements during the period of transition to the Union's common market of medicines," noted Valentin Tataritsky, the EEC Minister in charge of Technical Regulation.