Tag Archives: pharmacovigilance

Regulation on pharmacovigilance adopted by Roszdravnadzor came into force on 01 April 2017

1.04.2017 the Order of Federal Service for Supervision in Healthcare (hereinafter–“Roszdravnadzor”) No. 1071 dated 15.02.20171 came into force (hereinafter – “Order”). The Order provides for the Roszdavnadzor supervision over pharmacovigilance.

According to the current legislation the  pharmacovigilance is defined as a kind of activity comprising monitoring efficiency and safety of medical drugs. The purpose of pharmacovigilance is to identify, evaluate and prevent adverse drug reactions2.

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