Drug product safety monitoring

Safety monitoring of drug products in circulation on the territory of the Russian Federation.

In accordance with the Federal Law No. 323-FZ “On fundamental healthcare principles in the Russian Federation” as of 21.11.2011 (further — Federal Law No. 323-FZ) drug products being in circulation on the territory of RF should pass safety monitoring.

The function on the performance of safety monitoring of drug products in circulation on the territory of the Russian Federation is assigned to the Federal Service for Supervision in the Sphere of Health Care and is carried out in accordance with the Order of the Russian Ministry of Health No. 175n as of 14.09.2012.

The purpose of this monitoring is an identification and prevention of side effects not specified in Core Data Sheet or in User’s manual for drug product, adverse effects when applying it, drug products interactions peculiarities, cases and circumstances creating a threat for life and safety of medical personnel when applying and exploitation of registered drug products.

We provide services for the performance of safety monitoring at the market allowing us to follow the rules of good pharmacovigilance practice and save the budget.

If you need more detailed information on all cooperation-related issues you may dial (499) 110-55-10 or use the feedback form on our website.

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