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
-
Non-prescription medicines can be placed on open shelves in pharmacies only if the ANSM lists them. The holder asks for listing. If the product information must change first, a type II variation comes before the listing request. The ANSM handles requests in about 30 days. A non-reimbursed, non-prescription medicine that patients can use with the pharmacist's advice.
1. Change the product information (if needed); 2. Ask for listing; 3. Listing decision (30 days).
Outcome: Listing of the presentation on the direct-access list.
Legal basis: Code de la santé publique, Article R.5121-202
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 30 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
| Decisionofficial guidance. Approximate handling time. This is an official target, not an actual review time. | 30 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: Decentralised procedure with France as reference member state (national steps), Mutual recognition procedure in France (national steps), Traditional herbal medicine registration, Homeopathic medicine registration, Parallel import authorisation, 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.