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EC pharmacovigilance measures adopted

The European Parliament has voted in favour of the first section of the 'pharmaceutical package' legislation

Today, the European Parliament voted in favour of the European Commission's (EC) proposal on pharmacovigilance. This is the first part of the 'pharmaceutical package' of legislation to be adopted. The two other parts concern information offered to patients and measures to reduce counterfeiting.

Under the legislation, which has been broadly welcomed by stakeholders, national and European medicines web portals will be established and linked to give patients more information on medicines and any proven side-effects.

Sites will include assessments, product characteristics summaries and patient information leaflets (PILs) as well as information on how to report suspected adverse drug reactions (ADRs).

Further, new medicines will be identified by a black symbol with the statement: 'This medicinal product is subject to additional monitoring', together with a brief explanation.

The European EudraVigilance database will be developed and strengthened to become the single reception point for all pharmacovigilance information from pharmaceutical companies and national authorities and will be made accessible to an 'appropriate extent' to other pharmaceutical companies, healthcare professionals and the public.

The revisions to the legislation set out to define the roles and responsibilities of the parties involved more clearly, with the aim of bringing about a number of provisions to improve transparency and communication on medicines safety issues.

To ensure availability of the necessary expertise and resources for pharmacovigilance assessments at European Community level, a Pharmacovigilance Risk Assessment Committee will be created within the European Medicines Agency (EMA).

Commenting on the vote, Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said: "EFPIA has consistently been supportive of these efforts to strengthen and rationalise the EU's pharmacovigilance system. Whilst some of the provisions raise concerns, and will require carefully considered implementing measures be adopted in order to deliver the stated objectives of the legislation, on balance, it is a positive move. EFPIA is fully committed to helping implement the new legislation."

He went on to urge MEPs to act decisively on the other two sections of legislation: "We hope that the EU's decision makers will demonstrate the same decisive action in adopting the proposals on information to patients and on measures to reduce counterfeiting."

Speaking before today's vote, President of the Pharmaceutical Group of the European Union (PGEU) Filip Babylon said: "I believe the new directive is a significant step in creating a basis for effective collaboration between pharmacists and patients in the area of medication safety."

22nd September 2010

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