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EAEU adopted package of temporary measures to accelerate medicines launch
The Eurasian Economic Commission’s Council has adopted a package of temporary special measures in the field of medicines circulation.
Authorized bodies of all Eurasian Economic Union countries in the field of medicines circulation have the right to establish a special procedure for registering medicines if any shortage or its risk occurs in light of external economic impact.
The Council's decision makes it possible to automatically extend until 2023 the validity of all permits issued in accordance with the Union’s law, in other words, marketing authorizations and the Union’s GMP certificates for manufacturing sites. Besides, it is allowed to simultaneously inspect manufacturing sites for compliance with GMP requirements, including by remote inspection, and register medicines according to the Union’s rules, as well as conduct such GMP inspections in a post-authorization mode.
These measures will enable reducing the time of launching pharmaceuticals onto the market, and eliminating any risks associated with the shortage of medicines at the registration stage.
The adopted package of measures is temporary and shall remain in effect until December 31, 2023.
