Russia Will only Accept Registration of Drugs in Accordance with EAEU Rules since 2021

The press service of The Ministry of Industry and Trade of the Russian Federation said that there’s a proposition to accept registration dossiers for new medicines only within the framework of the rules of the Eurasian Economic Union since January 1, 2021. Moreover, the national legislation of the countries included in the EAEU will not be applied. The corresponding bill was developed by the Ministry of Industry and Trade with the participation of the Ministry of Agriculture. Registration of drugs for veterinary use is proposed to be accepted in the framework of national legislation until 2024.

It is important that we propose to terminologically divide the concept of “drugs” into “drugs for medical use” and “veterinary drugs”. This will make it possible to harmonize the provisions of the Russian legislation in the field of circulation of medical drugs with the relevant requirements of the Eurasian Economic Union. At the same time, minimal changes will be introduced into Russian legislation,

the words of the Minister of Industry and Trade Denis Manturov

As the ministry noted, the bill also aims to resolve issues of inspection of pharmaceutical manufacturers: now manufacturers will receive a certificate of compliance with the requirements of good manufacturing practice of the Eurasian Economic Union.