What Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires
This regulation establishes the framework for the designation of orphan medicinal products in the EU for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 persons in the EU, or where there is no return on investment without incentives (Article 3). It grants 10 years of market exclusivity, protocol assistance, and fee reductions upon designation and authorisation.
Pillar: Biotech & Genomics · Authority: European Medicines Agency (EMA) on behalf of the European Union · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32000R0141
SHA-256 integrity: 396d0c8f9aba0fe30531326bb4794c104a5044efb75e73adb97fb41c87fac7fe
Primary Citations — 5 traced to source
- Regulation (EC) No 141/2000, Article 3 - Criteria for designation of orphan medicinal products
- Regulation (EC) No 141/2000, Article 5 - Procedure for designation of orphan medicinal products
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