France · National Agency for the Safety of Medicines and Health Products · Vaccines
Review target
-
Not published
Legal time limit
60 days
regulation
Steps
3
3 requirements
Application fee
-
Vaccines and blood-derived medicines follow the usual marketing authorisation routes, and biotechnology products use the EU centralised procedure. In addition, each lot is released by a national authority. The ANSM tests each lot in parallel with the manufacturer. The maximum time to release a vaccine lot is 60 days, a limit set by the EU. Each lot of a vaccine or blood-derived medicine before it is placed on the market.
1. Send the lot release request; 2. Testing and release (60 days); 3. Fee invoice.
Outcome: Release of the lot by the ANSM.
Legal basis: Code de la santé publique; EU rules on official control authority batch release
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. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitregulation. Maximum time to release a vaccine lot, set by the EU. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.