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
2 requirements
Application fee
€7,600
2026 schedule
Some homeopathic medicines can use a simplified national registration instead of a full marketing authorisation. Fees depend on the number of homeopathic stocks. As for authorisations, a registration is treated as renewed if the agency is silent at expiry. Homeopathic medicines that meet the conditions for simplified registration.
The homeopathic registration, six or more stocks is €7,600 for 2026 schedule.
1. Send the application; 2. Assessment; 3. Registration decision.
Outcome: A registration issued by the ANSM.
Legal basis: Code de la santé publique, Article L.5121-13 and related regulations
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 |
|---|---|
| Homeopathic registration, six or more stocksApplication · 2026 schedule | €7,600 |
| Homeopathic registration, single stock (marketed after 18 January 1994)Application · 2026 schedule · Two to five stocks: 2,478 euros. Renewal: 1,500 euros. | €1,768 |
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, 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.