Swissmedic Contact, Address and Telephone
Short answer
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.
Which address applies to what?
Hallerstrasse 7 is the postal address. Applications go through the Portal; parallel postal delivery is only needed where the procedure expressly requires it. Vigilance reports go through the electronic reporting system, and narcotics licences through the corresponding technical portal.
| Matter | Channel | Note |
|---|---|---|
| Authorisation application, variation | Swissmedic Portal | electronic, eCTD preferred |
| Licence application | Swissmedic Portal | form plus annexes |
| Report of an adverse reaction | Electronic vigilance system | observe deadlines |
| Quality defect or suspected falsification | Market Surveillance reporting form | without delay |
| General technical question | Division or switchboard | not a procedural action |
| Media enquiry | Communications | own contact point |
| Invoices and fees | Finance | state the reference number |
What form must submissions take?
Procedural actions require the written form or submission via the Portal using the prescribed forms. An email to a specialist does not substitute for a submission and does not meet a deadline. Deadlines are met if the submission is filed, or handed to the post office, on the last day of the period.
- Applications and comments via the Portal or in writing with a signature.
- Deadlines: receipt on the last day is enough; for letter post the postmark counts.
- Choice of language: German, French or Italian; avoid switching mid-procedure.
- Representation: enclose a power of attorney where a consultancy is acting.
- References: state the authorisation number or case number in every submission.
How do I request advice?
Through an application for scientific or regulatory advice. You formulate specific questions with supporting documents, Swissmedic sets a date, and the meeting is minuted. Advice is fee-based and not binding on the authority, but it clarifies procedural questions in advance.
- Formulate the questions in writing, stating your own position and the data for each.
- Submit the advice request with documents via the Portal.
- Confirm the date and participants, involving specialists with decision-making authority.
- Hold the meeting, review the minutes and make corrections within the deadline.
- File the minutes in the dossier and reference them in the application's reasoning.
Where can you find public information?
swissmedic.ch carries forms, guidance, lists of authorised medicinal products, recall notices and the Swissmedic Journal. The approved medicinal product information can be retrieved via AIPS. The swissdamed database is available for medical devices.
Frequently asked questions
What is Swissmedic's telephone number?
The switchboard can be reached on +41 58 462 02 11. Individual divisions have their own numbers, published on the website.
Where is Swissmedic in Bern?
Hallerstrasse 7, 3012 Bern, in the Länggasse district near the university. Visits are by appointment only.
Can I submit an application by email?
No. Applications go through the Portal or, where provided for, in writing. Email is intended for informal technical questions and does not meet a deadline.
In which language should I write?
In German, French or Italian. Scientific parts of the dossier are largely accepted in English, but not the medicinal product information.
Are there regional offices?
Swissmedic operates from Bern. Some inspections are carried out by the regional inspectorates, which have their own locations.
Sources
Last updated: