What Commission Regulation (EC) No 141/2000 of 16 December 1999 on Orphan Medicinal Products requires
This regulation requires that medicinal products intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in the European Union at the time of application, meet specific criteria for orphan status as outlined in Article 3. The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) is responsible for assessing applications for orphan designation, as stated in Article 4.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32000R0141
SHA-256 integrity: 872f10d837447c4d1b55aa7475864be0b56a3a459448941b4c5d025bd6753c80
Primary Citations — 5 traced to source
- Commission Regulation (EC) No 141/2000, Article 3 - Criteria for Orphan Status
- Commission Regulation (EC) No 141/2000, Article 4 - Committee for Orphan Medicinal Products
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