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Public Health (26-06-2013)

Proposal for fees for pharmacovigilance payable to the European Medicines Agency adopted today

The Commission has today adopted a legal proposal which would see pharmaceutical companies pay specific fees for Union-wide pharmacovigilance activities.

This is due to the recent legislation on pharmacovigilance 1 applicable in the EU since July 2012, which significantly broadens the tasks of EMA - a decentralised EU agency, reinforcing its role as a hub for the coordination of the scientific resources made available by the Member States.

The proposal lays down the structure and level of these fees, and will now be discussed by the European Parliament and the Council.


Background

The EU has rules for the strict assessment of the quality, safety and efficacy of medicines before they are placed on the market. This, and the continued safety monitoring of these medicines through pharmacovigilance, aim at ensuring Europeans that the medicines they take are safe, of high quality and that they work.

 

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[1] Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines.