France · National Agency for the Safety of Medicines and Health Products · Generics
Review target
-
Not published
Legal time limit
210 days
regulation
Steps
7
5 requirements
Application fee
€14,700
2026 schedule
A generic needs a marketing authorisation from the ANSM through the national, mutual recognition or decentralised procedure. The file includes bioequivalence studies against the reference medicine. The ANSM then lists the generic in the published generics register, and pharmacists may substitute it only after publication. A generic of a reference medicine authorised in France.
The generic or biosimilar application, national procedure is €14,700 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, then an ANSM decision listing the product in a generic group.
Legal basis: Code de la santé publique, Article R.5121-28 (generic applications) and the generics register
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.
From the official approvals data of this market, all products of this pathway type and segment
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 |
|---|---|
| Generic or biosimilar application, national procedureApplication · 2026 schedule · Decentralised procedure with France as reference member state: 23,100 euros. | €14,700 |
Other routes in France: National marketing authorisation (full dossier), National marketing authorisation for a known substance (hybrid, new combination, new indication, bibliographic), 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 (23 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.