The European Medicines Agency (EMA) has released the latest two modules on good pharmacovigilance practice (GVP) for public consultation as part of a number of pharmacovigilance activities in support of the new legislation, effective from July 2012.
The modules cover the following major processes in the safety monitoring of medicines:
Module IV: Pharmacovigilance audits; and
Module XV: Safety communication.
The Agency is seeking comments on the practical implementation of the legislation as outlined in these modules. The underlying legal requirements cannot be altered through this consultation process.
Introduced by Peter Arlett, Head of Sector on Pharmacovigilance and Risk Management, EMA has produced a video on the new pharmacovigilance legislation.
EMA has also relaunched, at the request of the European Parliament, its call for expressions of interest from representatives of patient and health professional organisations to sit on the new Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT). More information is available on the DG SANCO website.
For further information
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