Russian Ministry of Health Registered the First Drug in Accordance with EAEU Requirements

The Ministry of Health of the Russian Federation issued the first registration certificate according to the requirements of 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 the medicinal product Granisetron (concentrate for solution preparation for infusion, 1 mg/ml manufactured by Ozone LLC, Russia).

The registration certificate was issued as a result of the procedure of making the dossier of the product that has been registered via national procedure to comply the requirements of the Eurasian Economic Union due to the entry into force of the Agreement on the Uniform Principles and Rules for the Circulation of Medicines within the framework of the Eurasian Economic Union dated December 23, 2014 which is valid 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 to receive drug registration certificates of these countries.

https://gmpnews.net/2019/11/russian-ministry-of-health-registered-first-drug-in-accordance-with-eaeu-requirements

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