France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
90 days
regulation
Legal time limit
-
Not published
Steps
5
4 requirements
Application fee
€35,700
2026 schedule
A product already authorised in one EU member state is recognised in France through mutual recognition, which is mandatory in that case. France recognises the reference state's authorisation within 90 days, then issues the national authorisation within 30 days. France can also lead the procedure from a French authorisation, after a slot request. A product already authorised in an EU member state that the company wants to sell in France, or a French authorisation to be extended to other states.
The official review target is 90 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The mutual recognition, another state as reference (france concerned) is €35,700 for 2026 schedule.
1. Slot request (if France leads); 2. Send the application; 3. Recognition (90 days); 4. French translations (7 days); 5. National authorisation (30 days).
Yes. It relies on approvals from European Union (recognition).
Outcome: A national marketing authorisation in France identical to the reference authorisation.
Legal basis: Directive 2001/83/EC, Articles 28 to 39; Code de la santé publique
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 401 days end to end with the official step targets. 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
| Decisionregulation. National authorisation after the procedure ends. | 30 days |
| Review targetregulation. Recognition phase, no clock stop. This is an official target, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Mutual recognition, another state as reference (France concerned)Application · 2026 schedule | €35,700 |
| Mutual recognition, France as reference member stateApplication · 2026 schedule | €17,600 |
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), Traditional herbal medicine registration, Homeopathic medicine registration, Listing for direct access in pharmacies (self-selection), 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.