France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
5 requirements
Application fee
-
The ANSM can authorise, for a named patient, a medicine with no marketing authorisation in France for a serious, rare or disabling disease with no suitable treatment. Hospital doctors request it online. If the medicine is under commercial development, the company commits to file for early access within 12 months, or 18 months for rare diseases. A patient with a serious, rare or disabling disease and no suitable treatment, who cannot join a clinical trial.
1. Prescriber request; 2. ANSM decision; 3. Company files for early access (365 days).
Outcome: An authorisation for one patient, for a treatment period from 1 day to 1 year.
Legal basis: Code de la santé publique, Article L.5121-12-1 (II) and Articles R.5121-74 to R.5121-74-10
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 365 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: National marketing authorisation (full dossier), National marketing authorisation for a known substance (hybrid, new combination, new indication, bibliographic), Generic medicine: authorisation and listing in the generics register, Decentralised procedure with France as reference member state (national steps), Mutual recognition procedure in France (national steps), Traditional herbal medicine registration, Homeopathic medicine registration, Parallel import authorisation, Early access authorisation, Compassionate prescription framework (off-label use), Advanced therapy prepared on a non-routine basis (hospital exemption), Official batch release by the ANSM (vaccines and blood-derived medicines). See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.