Russian legislation dictates that any marketing authorization holder (MAH) or pharmaceutical manufacturer in Russia set up and manage a comprehensive pharmacovigilance system. There is an expectation (common across all members of the Eurasian Economic Union) that the MAH will appoint a local QPPV although provision is made for a company operating in more than one EEU country to appoint a single contact person to oversee activities in all the EEU countries that they operate in.
Most recently in early 2017, Order No. 1071 (the Procedure for the Implementation of Pharmacovigilance) was approved. This provides exceptional detail for MAHs in terms of pharmacovigilance processes. Pharmacovigilance activities are overseen by the Federal Service for Surveillance in Healthcare (Roszdravnadzor), which in turn reports to the Ministry of Healthcare of the Russian Federation (MINSZDRAV).
It is clear, however, that the quality of pharmacovigilance activities undertaken in the Russian market is still below par. The incidence of under-reporting of adverse event reports and the poor quality of many reports submitted is a cause for concern. Healthcare professionals in particular, lack an understanding of the importance of pharmacovigilance and this adversely affects their engagement with the necessary processes. There is a significant need for pharmacovigilance-related education among both healthcare professionals and patients.
Although pharmacovigilance regulations have been broadly harmonized with EU legislation, some local variations in application do occur.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Russia within a fully comprehensive outsourced pharmacovigilance solution.
For those involved in medicines/medicinal products and medical devices, the pharmacovigilance service package comprises: