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Image header Agence Europe
Europe Daily Bulletin No. 10133
Contents Publication in full By article 29 / 35
GENERAL NEWS / (eu) eu/medicine

Germany receives final warning to comply with EU rules on well-established medicinal use

Brussels, 05/05/2010 (Agence Europe) - On Wednesday 5 May, the European Commission sent a reasoned opinion to Germany for incorrectly applying EU rules on well established medicinal use when authorising medicinal products pursuant to Directive 2001/83/EC. EU law foresees a simplified authorisation procedure for medicinal products containing an active substance that has been extensively used for at least a decade in the European Union and is therefore considered to have a proven track record...

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