Swissmedic Explained: Mandate, Contact, Databases
Swissmedic is the Swiss Agency for Therapeutic Products, the national authorisation and supervisory authority for medicinal products and medical devices. This hub explains what the agency is responsible for, how to reach it, and which of its databases and portals you need day to day.
What does Swissmedic do?
Swissmedic authorises medicinal products, grants establishment licences, inspects operations, supervises the market, handles vigilance reports, controls narcotics, and pursues illegal therapeutic products. It is a public-law institution of the Confederation with its own accounts, funded predominantly through fees.
| Area | What is decided there |
|---|---|
| Authorisation of human medicinal products | Authorisation applications, variations, renewals |
| Authorisation of veterinary medicinal products | Applications for medicinal products in veterinary medicine |
| Licensing | Manufacturing, wholesale dealing, import and export, trading abroad |
| Inspections | GMP and GDP inspections, coordination with regional inspectorates |
| Market surveillance | Batch recalls, quality defects, market checks |
| Vigilance | Reports on medicinal products, medical devices, blood products |
| Narcotics | Licences, control, international reporting |
| Criminal law and illegal activity | Prosecuting breaches of the TPA |
Swissmedic is not responsible for reimbursement of medicinal products. The Federal Office of Public Health (FOPH) decides on inclusion in the Specialities List and on prices.
Who is responsible for what?
Responsibilities in the Swiss healthcare system are split: the Confederation for authorisation and reimbursement, the cantons for professional practice and retail. Sending a question to the wrong body costs weeks.
- Swissmedic: authorisation, licensing, inspections, market surveillance, vigilance.
- FOPH: Specialities List, prices, mandatory health insurance coverage, epidemics law.
- Cantons: licences to practise, pharmacy and drugstore operation, mail order licences.
- Ethics committees: authorisation of research projects involving human subjects.
- Regional inspectorates: inspections on Swissmedic's behalf.
In which languages does Swissmedic work?
Procedures are conducted in German, French or Italian. English is largely accepted for scientific parts of the dossier, but not for the medicinal product information: it must be available in German, French and Italian.
All guides in this hub
6 guides
- Featured3 min
What Is Swissmedic?
Swissmedic is the Swiss Agency for Therapeutic Products, the national authorisation and supervisory authority for medicinal products and medical devices. It is a public-law institution of the Confederation based in Bern, funded predominantly through fees, and employs around 450 people.
Read the guide - Featured3 min
Swissmedic Contact, Address and Telephone
Swissmedic's head office is at Hallerstrasse 7 in 3012 Bern, and the switchboard can be reached on +41 58 462 02 11. Applications and reports go through the Swissmedic Portal, not email. Technical questions go to the relevant division; procedural actions require the written form.
Read the guide - Featured3 min
Swissmedic Databases and Lists
Swissmedic publishes the list of authorised medicinal products, the approved medicinal product information via AIPS, the list of licensed operations, recall notices, and swissdamed for medical devices. Prices and reimbursement, by contrast, sit in the FOPH's Specialities List.
Read the guide - 3 min
ELViS: Swissmedic's Reporting Portal
ELViS is Swissmedic's Electronic Vigilance System. Healthcare professionals and marketing authorisation holders use it to report adverse drug reactions and quality defects. Serious cases must be reported within 15 days, with marketing authorisation holders submitting structured data sets.
Read the guide - 3 min
Swissmedic Journal: The Official Publication
The Swissmedic Journal is the Agency's official publication. It contains new authorisations, renewals, revocations, changes to the dispensing category, notices and decisions. For competitor monitoring and market access planning, it is the most reliable public source.
Read the guide - 3 min
Swissmedic Forms and Portals
Applications, reports and dossiers go through the Swissmedic Portal. Access requires the company to register and roles to be assigned. Forms are procedure-specific and updated regularly; an outdated form version leads to an extended deadline during formal review.
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Frequently asked questions
Is Swissmedic a federal office?
No. Swissmedic is a public-law institution of the Confederation with its own legal personality and its own accounts. It is legally separate from the FOPH but works together with it.
How do I reach Swissmedic?
Head office: Hallerstrasse 7, 3012 Bern, telephone +41 58 462 02 11. Technical enquiries generally go through the relevant division or the Portal; procedural actions require the written form.
Can I get advice before submitting?
Yes, through scientific and regulatory advice meetings. These are fee-based, are minuted, and are not binding on the authority, but in practice they prevent many queries.
Where do I find the list of authorised medicinal products?
Swissmedic regularly publishes a list of authorised human medicinal products. The approved medicinal product information is available through the AIPS information system.
Is this website run by Swissmedic?
No. Swiss Regulatory Guide is an independent service run by Swiss Regulatory Guide and is not affiliated with Swissmedic or the FOPH. Only the official sources are authoritative.
Sources
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