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Main  >  News  >  The first drug registration certificate in Russia was issued in accordance with the requirements of the EAEU

The first drug registration certificate in Russia was issued in accordance with the requirements of the EAEU

11/21/2019 | EAEU, drug registration

The Ministry of Health of the Russian Federation issued the first registration certificate prepared in accordance with Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78 “On the Rules for Registration and Expertise of Medicines for Medical Use” for a medicinal product for medical use, Granisetron (concentrate for solution preparation for infusion, 1 mg / ml produced by Ozone LLC, Russia).

The registration certificate was prepared on the basis of the procedure for bringing into compliance with the requirements of the Eurasian Economic Union the registration dossier of a medicinal product registered before the entry into force of the Agreement on Uniform Principles and Rules for the Circulation of Medicines within the framework of the Eurasian Economic Union of December 23, 2014 and until 31 December 2020

In the future, the company will be able to apply to the countries of the Eurasian Economic Union for recognition of the expert evaluation report for obtaining drug registration certificates of these countries.

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