France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
-
Not published
Legal time limit
210 days
regulation
Steps
7
12 requirements
Application fee
€35,700
2026 schedule
The national route for a medicine that will be sold only in France and is not authorised in any other EU member state. The ANSM checks the file within 14 days, then has 210 days from a complete file to decide. The clock stops while the company answers questions. A medicine intended only for the French market and not authorised in another EU member state, outside the mandatory scope of the EU centralised procedure.
The marketing authorisation application, national procedure (full dossier) is €35,700 for 2026 schedule.
1. Send the application; 2. Admissibility check (14 days); 3. Scientific assessment (210 days); 4. Answers to first questions (91 days); 5. Answers to second questions (if asked) (30 days); 6. Check of the draft authorisation (5 days); 7. Decision.
Outcome: A marketing authorisation (AMM) granted by the Director General of the ANSM, or a refusal. Valid for 5 years.
Legal basis: Code de la santé publique, Article L.5121-8 (marketing authorisation) and Article R.5121-35 (time limit)
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 315 days end to end with the official step targets, of which up to 121 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
| Validationofficial guidance. Admissibility answer by email. | 14 days |
| Longest clock stopofficial guidance. About 3 months to answer the first questions, with a possible 3-month extension. | 91 days |
| Legal time limitregulation. 210 days from a complete file. The clock stops while the applicant answers questions. This is an official target, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Marketing authorisation application, national procedure (full dossier)Application · 2026 schedule · Each extra strength or form sent at the same time costs 17,850 euros. The file is only complete with the payment receipt. | €35,700 |
Other routes in France: 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), Compassionate prescription framework (off-label use), Pharmaceutical establishment authorisation (operator, manufacturer, importer, distributor). See all routes on the France page or explore them in the Regulatory section.
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 (33 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet