Orphan medicinal products -- The role of the EMEA

Article type: Research Article

Authors: Patrick Le Courtois, | Melanie Carr,

Affiliations: Head of Sector New Chemical Substances, European Agency for the Evaluation of Medicinal Products (EMEA), 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK | Scientific Administrator, European Agency for the Evaluation of Medicinal Products (EMEA), 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

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.

Journal: Pharmaceuticals, Policy and Law, vol. 3, no. 0, pp. 31-35, 2001