AAP (Accès Précoce) – France
ATU/AAP ApplicationArticle L.5121-12 Code de la Santé Publique60 days
Description & Eligibility
France's early access authorization (formerly ATU) allows patients to access promising medicines before marketing authorization. Managed by ANSM under the reformed 2021 system (Article L.5121-12 Code de la Santé Publique).
Eligibility Criteria
Serious or life-threatening condition with no locally registered alternative
Legal Reference / Source
Article L.5121-12 Code de la Santé Publique
Countries Using This Pathway (1)
AAP (Accès Précoce) – France
| Approval Form | ATU/AAP Application |
| Timeline | 60 days |
| Legal Status | Article L.5121-12 Code de la Santé Publique |
| Source Ref. | Article L.5121-12 Code de la Santé Publique |
| Countries | 1 countries |
Compliance Check
Legal Review3/11/2026
Global ValidityVerified