France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
210 days
regulation
Legal time limit
-
Not published
Steps
7
5 requirements
Application fee
€55,000
2026 schedule
When a company wants France to lead a decentralised procedure, it first asks the ANSM for a slot 6 to 9 months ahead. The request is discussed at a slot meeting, and a pre-submission meeting follows. After the EU procedure, the company sends French translations within 7 calendar days and the national authorisation follows within 30 days. A product not yet authorised in any EU member state, to be authorised in France and other member states at the same time, with France leading.
The official review target is 210 days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The decentralised procedure, france as reference member state (full dossier) is €55,000 for 2026 schedule.
1. Ask for a slot; 2. Acknowledgement (10 days); 3. Slot allocation meeting; 4. Pre-submission meeting; 5. EU decentralised procedure (210 days); 6. French translations (7 days); 7. National authorisation (30 days).
Outcome: A national marketing authorisation in France and in each concerned member state.
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 531 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 EU procedure ends. | 30 days |
| Review targetregulation. EU decentralised procedure. This is an official target, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Decentralised procedure, France as reference member state (full dossier)Application · 2026 schedule · France as a concerned member state: 35,700 euros. Each extra strength or form with France as reference: 27,500 euros. | €55,000 |
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, Mutual recognition procedure in France (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 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.