France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
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The ANSM can set a framework for prescribing an authorised medicine outside its approved indications when a group of patients has an unmet need and published data suggest a favourable benefit-risk balance. Signals come from national bodies such as the cancer institute, rare disease centres and patient associations. A framework lasts 3 years and can be renewed. Off-label use of an authorised medicine to meet an unmet need for a group of patients.
1. Signal of an off-label need; 2. ANSM assessment; 3. Consultation of the company; 4. Publication.
Outcome: A published framework, with a patient follow-up protocol where needed. Valid for 3 years.
Legal basis: Code de la santé publique, Article L.5121-12-1 (III)
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).
Official step durations
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 access authorisation (named patient), Official batch release by the ANSM (vaccines and blood-derived medicines), Pharmaceutical establishment authorisation (operator, manufacturer, importer, distributor). 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.