04.05.2017

Main Eurasian Economic Union (EEU) regulations of common biopharma & medtech market (Russia, Belarus, Kazakhstan, Armenia, and Kirgizstan) will officially come into effect since 06-May-2017

All registration dossiers of the drugs, registered in EEU members before 2016 or in accordance with the updated national regulations before 2021, should be aligned with EEU regulations’ requirements and provided in CTD format before 31-Dec-2025. Since 2019, all drug dossiers submitted within EEU regulations must include EEU GMP; national GMP/license will not be sufficient.