The revised European pharmacovigilance legislation was published by the European Commission on 31 December 2010. The MEB participated actively in the revision of this legislation, which will enter into force in July 2012.
It aims to better protect and promote public health by:
- Increasing public involvement in pharmacovigilance.
- Increasing transparency.
- Improving communication of decisions and reasons of decisions.
- Providing a legal basis for more proactive pharmacovigilance.
- Simplifying reporting rules for e.g. spontaneous adverse drug reactions.
- Improving pharmacovigilance efficiency.
The MEB endorses the basic principles of this new legislation, which puts patients first in the system of identifying and managing reports of potentially medicine-related health risks, and also aims for improved implementation of European medicine safety measures in national health care systems. The MEB participated actively in the amendment of this legislation, which involved both Regulation (EC) No. 726/2004 and Guideline 2001/83/EC.
The new legislation, a Regulation and a Directive , will become applicable in July 2012. The upcoming period will be marked by preparing the organisation, Marketing Authorisation Holders and other target groups for the changes involved in this legislation. The MEB is working closely with national and international partners to achieve a succesfull implementation. The MEB plans to organise informative meetings for marketing authorisation holders during the last quarter of 2011 and in spring 2012.
