Frequently asked questions about a Swiss MAH
The questions that come up in almost every first call, answered in the order they usually arrive. If yours is missing, the form below reaches a regulatory lead, not a mailbox.
The legal basics
Three provisions carry most of the answers on this page: Art. 10 HMG for the Swiss domicile of the holder, Art. 13 HMG for the use of foreign assessment results, and Art. 59 HMG for the duty to report adverse reactions. Everything operational follows from those three.
- Art. 10 HMG. The applicant must have a domicile, a registered office or a branch in Switzerland.
- Art. 13 HMG. Swissmedic takes account of the assessment results of an authority with comparable controls.
- Art. 14 HMG. Simplified authorisation for defined categories, including medicines for rare diseases.
- Art. 59 HMG. The duty to collect, assess and report suspected adverse reactions.
- AMBV. Establishment licences for manufacture, import, export and wholesale, with a named responsible person.
Timelines you can plan with
These are planning figures from their own files. They are not promises, because Swissmedic clock time depends on the procedure and on the quality of the submission.
| Step | Plan on | Note |
|---|---|---|
| Contract and quality agreement | 2 to 4 weeks | Can run parallel to dossier work |
| Transfer of an existing authorisation | About 90 days | Fastest route to a Swiss holder |
| Swiss submission preparation | 4 to 10 weeks | Driven by three-language product information |
| Swissmedic review | Procedure dependent | Foreign assessment results shorten it |
| SL reimbursement | Several months | File as early as the procedure allows |
| Approval to first delivery | 6 to 12 weeks | Artwork and production are the limit |
Working with the providers
External providers are a team of specialists in Switzerland, not a global network with a Swiss letterbox. That has consequences you should know about before you choose the providers: you get named people and direct answers, and external providers decline mandates external providers cannot run properly.
- You get one named regulatory contact plus the responsible specialist per function.
- Correspondence with you can be in English throughout; with the authorities it is German or French.
- External providers do not hold authorisations without controlling pharmacovigilance.
- External providers check portfolio conflicts before signing and decline direct competitor mandates without consent.
- Every contract contains an exit clause that transfers the authorisation back to you.
Frequently asked questions
What is a Marketing Authorisation Holder in Switzerland?
The company named on the Swissmedic authorisation certificate, in German the Zulassungsinhaberin. It is legally responsible for the product in Switzerland: dossier accuracy, product information, pharmacovigilance, defect handling and the annual fee. It must have a Swiss domicile under Art. 10 HMG and does not have to be the manufacturer.
Can a foreign company be the holder?
Not without a Swiss domicile. A foreign company either registers a Swiss entity or branch, or appoints an established Swiss company as holder. There is no light-touch local representative status for medicines, unlike the CH-REP role that exists for medical devices.
How much does a Swiss MAH service cost per year?
It is quoted per mandate, built from a fixed annual holder fee per authorisation plus the modules you need and the authority fees at cost. The drivers are the number of authorisations and packs, the dispensing category, the variation frequency and whether pharmacovigilance, release, import and reimbursement are in scope.
How quickly can we have a Swiss holder in place?
The contract and the quality agreement take two to four weeks. For an existing Swiss authorisation the holder change takes about 90 days. Where no Swiss authorisation exists, the holder is in place from the first submission, and the timeline is then driven by the authorisation procedure.
Do you take products with quality or compliance history?
External providers look at them seriously and sometimes decline. A product with an unresolved quality problem or an inspection history that has not been fixed becomes their inspection history the day external providers sign, so external providers do the due diligence before, not after.
What happens if we want to leave?
You give notice, external providers transfer the authorisation to you or a party you name, and external providers hand over the Swiss dossier, the safety documentation and the release records. It is a standard clause, not an end-of-relationship negotiation, and external providers have executed it in both directions.
Enquire about Swiss MAH support
Describe your product, dossier status and support needs. Enquiries reach the website operator at info@mahswitzerland.com. Provider qualifications, availability and contracts must be checked separately.
- Independent information portal
- Public Swiss sources, independent explanations, and enquiries about external specialist services.