Switzerland · Swissmedic · Over-the-counter
Review target
330 days
official guidance
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
-
A non-prescription medicine with an indication can be authorized in a simplified way if it has been in medical use for at least 30 years, including at least 15 years in EU and EFTA countries. Pharmacology, toxicology and clinical documentation can be left out, but the leaflet states that the agency did not check safety and efficacy. The fee is 70 percent lower. Traditional non-prescription medicines with long documented use in Europe.
The official review target is 330 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Submit the application; 2. Review in standard time limits; 3. Official decision.
Yes. It relies on approvals from European Union (reference approval required).
Outcome: Authorization for five years, renewable. Valid for 5 years.
Legal basis: Therapeutic Products Act (HMG) Articles 14 para. 1 let. ater and 14a para. 1 let. b; Ordinance on Simplified Authorisation (VAZV) Article 17c; Fee Ordinance Article 10
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
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Official target for agency time only, counted in calendar days. Time the applicant takes to answer is not counted. Actual review times can differ. The standard time limits apply. The maximum total, including applicant time, is 540 days. | 330 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Switzerland: Ordinary authorization of a medicine with a new active substance, Simplified authorization of a known active substance with innovation, Simplified authorization of a generic (known active substance without innovation), Authorization based on a foreign authorization (Article 13 procedure), Fast-track authorization procedure, Procedure with prior notification (20 percent shorter review for a double fee), Temporary authorization (incomplete data), Orphan drug status (important medicine for a rare disease), Simplified authorization for active substances used for ten years in the EU or EFTA, Non-prescription status: dispensing category and switch, Simplified authorization of herbal and complementary medicines, Simplified authorization for a parallel import, Temporary permit for use outside clinical trials or limited marketing, Pediatric investigation plan and pediatric incentives. See all routes on the Switzerland 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.