Switzerland · Swissmedic · New drugs
Review target
330 days
official guidance
Legal time limit
-
Not published
Steps
8
5 requirements
Application fee
CHF 4,000
2026
A second distributor can get a simplified authorization for a medicine already authorized in Switzerland and imported from a country with an equivalent authorization system. The imported product must meet the same requirements as the Swiss product, including labeling and product information, with some simplifications. Import of a medicine already authorized in Switzerland from a country on the agency's list of comparable countries.
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.
The new authorization, parallel import is CHF 4,000 for 2026.
1. Submit the application; 2. Formal control and technical validation (30 days); 3. Applicant corrects formal gaps (clock stopped) (60 days); 4. Evaluation phase I (120 days); 5. Applicant answers the list of questions (clock stopped) (90 days); 6. Evaluation phase II and preliminary decision (90 days); 7. Applicant replies to the preliminary decision (clock stopped) (60 days); 8. Labeling review and official decision (90 days).
Outcome: Authorization of the imported product for the second distributor.
Legal basis: Therapeutic Products Act (HMG) Article 14 paras. 2 and 3
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 480 days end to end with the official step targets, of which up to 210 days are clock stops (time the applicant uses to answer). Targets, not actual times.
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
| 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 maximum total, including applicant time, is 540 days. | 330 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New authorization, parallel importApplication · 2026 | CHF 4,000 |
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, Simplified authorization for long-used non-prescription medicines, Non-prescription status: dispensing category and switch, Simplified authorization of herbal and complementary medicines, 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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.