France · National Agency for the Safety of Medicines and Health Products · New drugs
Review target
-
Not published
Legal time limit
45 days
regulation
Steps
4
3 requirements
Application fee
€5,000
2026 schedule
A medicine authorised in another EEA state can be imported in parallel if it is identical to a product already authorised in France. The ANSM decides within 45 days of a complete file, and silence means refusal. The authorisation lasts 5 years and can be renewed. Importing from another EEA state a product identical to one authorised in France.
The parallel import authorisation is €5,000 for 2026 schedule.
1. Send the application; 2. Review (45 days); 3. Extra information (if asked) (15 days); 4. Decision.
Yes. It relies on approvals from European Union (uses the reference review).
Outcome: A parallel import authorisation, published by the ANSM. Valid for 5 years.
Legal basis: Code de la santé publique, Articles R.5121-115 to R.5121-132
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 60 days end to end with the official step targets, of which up to 15 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
| Legal time limitregulation. Silence after 45 days means refusal; 15 more days if more information is asked. | 45 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Parallel import authorisationApplication · 2026 schedule · Five-yearly renewal: 674 euros. | €5,000 |
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, 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), 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 or explore them in the .
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.