France · National Agency for the Safety of Medicines and Health Products · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
6 requirements
Application fee
€14,000
2026 schedule
A simplified registration for herbal medicines with long traditional use, at least 30 years including 15 years in the EU. No clinical or nonclinical trial results are needed, but a bibliographic safety review with an expert report is. The ANSM issues a registration rather than a marketing authorisation. Herbal medicines for oral, external or inhaled use, with indications suited to use without medical supervision.
The traditional herbal registration, national procedure is €14,000 for 2026 schedule.
1. Send the application; 2. Assessment; 3. Registration decision.
Outcome: A registration issued by the ANSM. Valid for 5 years.
Legal basis: Code de la santé publique, Article L.5121-14-1 and Articles R.5121-107-3 and following
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).
Official step durations
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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Traditional herbal registration, national procedureApplication · 2026 schedule · Decentralised procedure with France as reference: 21,000 euros. Renewal: 5,000 euros. | €14,000 |
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), 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 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.