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Legislation to strengthen EU pharmacovigilance is 'welcome’

EFPIA, the voice of the research-based pharmaceutical industry in Europe, has welcomed the European Parliament’s adoption of the Commission’s proposal on pharmacovigilance.

The proposal is the first section of the ‘pharmaceutical package’ of legislation to be adopted. Commenting on the vote, Brian Ager, the Director General of EFPIA, said: ‘EFPIA has consistently been supportive of these efforts to strengthen and rationalise 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.’

Mr Ager went on to point out that this was only one part of the pharmaceutical package and urged MEPs to act decisively on the other sections of legislation, commenting: ‘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.’

The revisions to the legislation will more clearly define the roles and responsibilities for the key responsible parties, and this will bring about several provisions aiming to improve transparency and communication on medicine’s safety issues.

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

The Community pharmacovigilance database, ‘EudraVigilance’, will also be further developed and strengthened, becoming the single point of receipt for pharmacovigilance information. In addition, the direct the reporting of suspected adverse reactions (ADRs) by patients to medicinal products will be facilitated.

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