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The European Medicines Agency is a decentralised body of the European Union (EU) responsible for the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. Through the Agency, companies can seek a single marketing authorisation for medicines that is valid in the whole of the EU and in the EEA/EFTA states (Iceland, Liechtenstein and Norway). In addition to the scientific evaluation of applications through the centralised procedure, the Agency has a legal responsibility to co-ordinate pharmacovigilance and monitor the safety of medicines throughout Europe.
Many exciting and innovative medicines are being, and will continue to be, licensed through the centralised procedure. Through ENCePP, there will be the ability to plan and perform the pan-European studies necessary to answer unresolved questions, and the public will have the assurance that the research is of the highest quality and the results will be applicable to the European population.
In line with its Road Map to 2010 and the Pharmaceutical Legislation, the Agency is promoting the establishment of ENCePP, in order to facilitate the generation of highly reliable pharmacoepidemiological data for proactive pharmacovigilance purposes. ENCePP will complement the existing tools (RMP, EudraVigilance, etc) of the EU pharmacovigilance system. It aso adds to current efforts to further strengthen and rationalise pharmacovigilance in the EU as reflected in the legislative provisions of the European Commission's Strategy to Better Protect Public health by Strengthening and Rationalising EU Pharmacovigilance, released for public consultation in December 2007.
