EMA Orphan Drug Designation
Statutory
Description & Eligibility
EU designation for medicines treating life-threatening or chronically debilitating rare conditions (prevalence <=5 in 10,000), granting up to 10 years market exclusivity.
Legal Reference / Source
Regulation (EC) No 141/2000
EMA Orphan Drug Designation
| Legal Status | Statutory |
| Source Ref. | Regulation (EC) No 141/2000 |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified