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Regulatory Issues Concerning Behavioral and Psychological Symptoms of Dementia in Europe

Published online by Cambridge University Press:  10 January 2005

Ian G. McKeith
Department of Old Age Psychiatry, Institute for the Health of the Elderly, Wolfson Research Centre, Newcastle General Hospital, Newcastle upon Tyne, UK.


In 1995, a new European system for the authorization of medicinal products went into effect. After 10 years of cooperation between National Registration Authorities at the European Union (EU) level and 4 years of negotiation, in June 1993 the Council of the EU adopted three directives and a regulation that together form the legal basis of the current system. The European Medicines Evaluation Agency (EMEA) was established on July 22, 1993, and London was chosen as its coordinating center, housing the Committee for Proprietary Medicinal Products (CPMP), which is the body that advises the European Licensing Authority (European Commission). The EMEA has the opportunity to harness the expertise and resources of member states and their ability to oversee local implementation.

Regulatory Issues
© 2000 International Psychogeriatric Association

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