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Image header Agence Europe
Europe Daily Bulletin No. 9165
Contents Publication in full By article 37 / 44
GENERAL NEWS / (eu) eu/medicines

31/03/2006 (Agence Europe) - On 29 March, the European Commission adopted an implementing regulation organising conditional marketing authorisation for medicines for human use introduced by the reform of European pharmaceutical legislation adopted in March 2004. These conditional authorisations seek to allow the temporary use in emergencies of new medicines to be used to treat seriously debilitating or life-threatening diseases. They must give patients affected a “major therapeutic advantage” without having to wait for all the data needed for full marketing authorisation. Medicines used for curative and preventive purposes, and diagnostic products are affected by the regulation. The conditional marketing authorisation is valid for one year and may be renewed annually until full marketing authorisation is obtained. The Commission regulation was published in the Official Journal L 92 on 30 March.

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