France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
90 days
official guidance
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
A company that operates medicines in France (the exploitant), or manufactures, imports or distributes them, needs an ANSM-authorised pharmaceutical establishment led by a responsible pharmacist. The standard review takes 90 days. Manufacturers of new or innovative medicines can use a 60-day accelerated route. Before operating, manufacturing, importing or distributing medicines from a site in France.
The official review target is 90 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Present the project (accelerated route only) (91 days); 2. File the application; 3. Review (90 days); 4. Authorisation.
Outcome: An authorisation to open the establishment, published in the EU database.
Legal basis: Code de la santé publique, Article R.5124-2 (types of pharmaceutical establishments)
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 181 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
| Review targetofficial guidance. Standard review; 60 days on the accelerated route. This is an official target, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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), 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), Advanced therapy prepared on a non-routine basis (hospital exemption), Official batch release by the ANSM (vaccines and blood-derived medicines), Biosimilar substitution by the pharmacist. 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.