Pharmacovigilance

Pharmacovigilance – a type of activity aimed at detecting, evaluating, understanding and preventing of adverse effects of drug administration.

Within the EAEU, pharmacovigilance is regulated by Decision No. 87 of the Eurasian Economic Commission Council dated November 3, 2016 “On Approving the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union”     Good Pharmacovigilance practices GVP (download).

Contract research organization PharmAssistance provides the following pharmacovigilance services:

• Organization of collection, processing and analysis of the AE/SAE/SAR/SUSAR

• Organization of a local pharmacovigilance system

• Organization of a 24 hours call center for signals collection

• Development of Periodic Safety Reports (PSUR)

Development of Risk Management Plans (RMP) The organization of a local pharmacovigilance system in the EAEU is mandatory for applicants planning the registration of medicines in the territory of the Union. The master file of the pharmacovigilance system of the marketing authorization holder or a brief description of the pharmacovigilance system is provided in Module 1 of the registration dossier (Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 “On the Rules for Registration and Expertise of Medicines for Medical Use”).