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.

Please note that the deadline for comments for these draft guidelines is 21 September 2012.

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

- European Medicines Agency website - Pharmacovigilance

EPHA related articles
- Pharmacovigilance: Transitional arrangements published & EMA consultation on good pharmacovigilance practice
- EMA reflection paper discusses globalisation of clinical trials
- The European Medicines Agency launches website on new European database of suspected adverse drug reaction

Last modified on August 30 2012.