France · Haute Autorité de santé · New drugs
Review target
-
Not published
Legal time limit
90 days
regulation
Steps
7
9 requirements
Application fee
-
Early access lets patients receive a presumed innovative medicine for a serious, rare or disabling disease with no suitable treatment, either before marketing authorisation (pre-AMM) or while reimbursement is pending (post-AMM). The HAS decides within 90 days of a complete file. For pre-AMM requests the ANSM gives a binding opinion on efficacy and safety, unless the EU committee has already given a favourable opinion. Health insurance covers the medicine automatically. A medicine for a serious, rare or disabling disease with no suitable treatment, where treatment cannot wait and the medicine is presumed innovative.
1. Pre-filing meeting (optional); 2. File the request; 3. Administrative admissibility (10 days); 4. Assessment (90 days); 5. Additional data (if asked) (45 days); 6. HAS decision; 7. Make the medicine available (61 days).
Outcome: A decision of the HAS granting early access for at most one year, renewable, with automatic coverage by health insurance. Valid for 1 years.
Legal basis: Code de la santé publique, Article L.5121-12 and Articles R.5121-68 to R.5121-73
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 161 days end to end with the official step targets, of which up to 45 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Validationregulation. Administrative admissibility. | 10 working days |
| Longest clock stopregulation. Total time for the company to provide extra data. | 45 days |
| Legal time limitregulation. 90 days from a complete file, excluding clock stops. Can be extended by 30 days when requests are exceptionally numerous. This is an official target, not an actual review time. | 90 days |
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, Compassionate access authorisation (named patient), 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 (24 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet