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
6 requirements
Application fee
€24,150
2026 schedule
A national application that builds on a medicine already authorised, for example a new strength, form, route or indication, a new combination, or a file based on published literature. For a hybrid, the company adds only the data that justify the differences from the reference product. The national time limits apply. A product sold only in France that differs from an authorised reference product, or relies on published literature.
The new combination, national procedure is €24,150 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.
Legal basis: Code de la santé publique, Articles R.5121-26 and R.5121-28 (transposing Article 10 of Directive 2001/83/EC)
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
What the applicant must provide or meet
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 |
|---|---|
| New combination, national procedureApplication · 2026 schedule | €24,150 |
| Application based on published literature, national procedureApplication · 2026 schedule | €24,150 |
| Different therapeutic indication, national procedureApplication · 2026 schedule | €24,150 |
| Hybrid (active substance differences or bioequivalence not shown), national procedureApplication · 2026 schedule | €14,700 |
Other routes in France: National marketing authorisation (full dossier), 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 (30 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.