EU definition of a rare disease: prevalence threshold for orphan medicinal product designation
not more than five in 10 thousand persons
people per 10,000, EU
“affecting not more than five in 10 thousand persons in the Community when the application is made”
Regulation (EC) No 141/2000 on orphan medicinal products, Article 3(1)(a), 1999-12-16
- Kind of source
- Registry or statistics office
- Read on
- 2026-11-06
- Daily check
- Quote found at the source on 2026-11-06
- What to know
- Legal text; the threshold applies at the time of the designation application. Regulation dated 16 December 1999, published 2000.
Used in
Kept as evidence; no figure on the platform is computed from it yet.