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Europe Daily Bulletin No. 8634

30 January 2004
Contents Publication in full By article 32 / 38
GENERAL NEWS / (eu) eu/medicines
Positive assessment of orphan medicines

Brussels, 29/01/2004 (Agence Europe) - Four years after it came into force, a positive assessment has been made of the orphan medicines regulation.

Under this regulation, designed to encourage research into rare diseases affecting fewer than 5 in every 10000 people in the EU, laboratories can receive aid and a reduction in fees for the centralised Authorisation to Market in the EU procedure (AM). Orphan medicines are given 10 years exclusive rights from the date of award of the AM. Over the...

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GENERAL NEWS