Supplying data concerning Pharmacovigilance System till 30 Nov 2018

Following the recommendation of the European Medicines Agency (EMA), to monitor the safety of the medicinal products for human use and to reduce their risk, based on the GVP Module III. B, point 2, the National Institute of Pharmacy and Nutrition (OGYÉI) IS CARRYING OUT A PHARMACOVIGILANCE RISK ASSESSMENT among marketing authorization holders, in the form of questionnaire.

The PHARMACOVIGILANCE questionnaire, compiled by the OGYÉI, is collecting the most important data relating to the pharmacovigilance (PV) system maintained by the marketing authorization holder, and to the potential PV “risk” of their products currently on the market.

OGYÉI is expecting the data supplying of all marketing authorization holders in Hungary in the form of filling in and submitting the following questionnaire.
link (form is available only in Hungarian language):
https://www.research.net/r/PV_risk_assessment

MA Holders has to submit filled up forms before 30 Nov 2018

You can find further information about local PHV service of Pro-Pharma in the main menu.