Abstract
The legislative framework for orphan medicinal products has recently been laid down in the European Union, with the adoption of Regulation (EC) No 141/2000 of 16 December 1999 and Commission Regulation (EC) No 847/2000 of 27 April 2000. The European Agency for the Evaluation of Medicinal Products (EMEA) with its new committee, the Committee for Orphan medicinal Products, now plays a major role in implementing the new legislation. A Community procedure has been established which will clearly identify orphan medicinal products eligible for incentives.
Incentives for sponsors developing orphan medicinal product available in the European Union include, amongst others, a 10 year period of market exclusivity, protocol assistance from the EMEA, and the possibility to request reduction of fees for all types of activities linked to the centralised marketing authorisation procedure.
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