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.