Russia Will Register Drug only in Accordance with EAEU Rules since 2021

28 November 2019

GMP News

The Ministry of Industry and Trade of the Russian Federation proposes from January 1, 2021 to register new drugs for medical use only within the framework of the rules of the Eurasian Economic Union, the press service of the ministry said. 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.

The registration of drugs for veterinary use until 2024 is proposed to continue in the framework of national legislation.

It is important that we propose to terminologically divide the concept of “drugs” into actually “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 are quoted in the message.

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.



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