France Compassionate Use (Article 83 EMA)
National compassionate use formRegulated under EU Directive 2001/83/EC30 days
Description & Eligibility
EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in France.
Eligibility Criteria
Serious or life-threatening condition with no locally registered alternative
Legal Reference / Source
EMA Article 83 Compassionate Use
Countries Using This Pathway (1)
France Compassionate Use (Article 83 EMA)
| Approval Form | National compassionate use form |
| Timeline | 30 days |
| Legal Status | Regulated under EU Directive 2001/83/EC |
| Source Ref. | EMA Article 83 Compassionate Use |
| Countries | 1 countries |
Compliance Check
Legal Review3/11/2026
Global ValidityVerified