MAH holding: a Swiss Marketing Authorisation Holder for your product
External providers are named as Zulassungsinhaberin on the Swissmedic certificate and carry the holder duties under Swiss therapeutic products law, while the product, the dossier and the commercial rights stay yours.
What does MAH holding mean in practice?
MAH holding means a Swiss company takes the legal position of authorisation holder for your medicine: it signs the application, appears on the Swissmedic certificate, answers for the product information, reports safety issues, pays the annual fee and receives every official letter. You keep ownership of the dossier and of the commercial relationship.
Art. 10 para. 1 HMG requires an applicant to have a domicile, a registered office or a branch in Switzerland. There is no Swiss equivalent of a mere local representative for medicines: the entity with the Swiss address is the holder, with the full duty set. That is the reason foreign companies either found a Swiss subsidiary or appoint an established holder with the appropriate authorisations.
Zulassungsinhaberin, titulaire, titolare
The four Swiss terms for the same legal role: Marketing Authorisation Holder (en), Zulassungsinhaberin (de), titulaire de l'autorisation de mise sur le marché (fr), titolare dell'omologazione (it). Swissmedic uses the German and French terms in its decisions and forms.
Which duties do external providers take over as holder?
The holder duties in Swiss law are concrete and auditable. External providers list them in the service agreement so there is no grey zone about who answers a Swissmedic letter, who updates a package leaflet and who reports an adverse reaction within 15 days.
- Dossier and application. Signing the application, maintaining the Swiss dossier, answering Swissmedic questions within the stated deadlines.
- Product information. Keeping the Fachinformation and Patienteninformation current in German, French and Italian, and publishing them where Swissmedic requires it.
- Labelling and artwork. Approving Swiss packaging text, the dispensing category wording and every artwork revision.
- Pharmacovigilance. A Responsible Person for Pharmacovigilance reachable in Switzerland, reporting through Swissmedic's ElViS portal, periodic safety reports.
- Quality events. Complaint handling, defect reports, field actions and recalls with Swissmedic and the cantonal authorities.
- Fees and renewals. The annual authorisation fee, the five-year renewal, and every fee-bearing change.
- Inspection readiness. Being the Swiss address an inspector can visit, with the documentation on site in Switzerland.
What you deliver, what external providers deliver
The split is stable across mandates. You own the science and the supply; external providers own the Swiss legal and administrative layer. The technical agreement written in onboarding step two puts every line below into a signed document.
| Topic | You | external MAH providers |
|---|---|---|
| Dossier content and CMC data | Owner and author | Swiss format, submission, defence |
| Swiss product information | Source texts, medical approval | Swiss version in de, fr, it |
| Swissmedic correspondence | Copied, consulted | Signs and answers as holder |
| Adverse reaction reports | Global database | Swiss intake, ElViS reporting, RPPV |
| Manufacturing and QP release | EU or global release | Swiss market release, import |
| Annual fee and renewals | Cost carrier | Filing and payment |
| Commercial rights and price | Owner and decision maker | Execution, SL application on request |
How long does it take to put a holder in place?
Contractually, two to four weeks. On the regulatory side it depends on whether a Swiss authorisation already exists. If it does, the fastest route is a change of holder, which is a change requiring Swissmedic approval. If it does not, holding starts with the application itself, and external providers are named as holder from the first submission.
- Scoping call and written scope, week 1.
- Service agreement and technical or quality agreement, weeks 2 to 4.
- Either the change of holder for an existing authorisation, or the Swiss application as holder, from week 4.
- Swissmedic decision, then artwork, import and first delivery.
What it costs and what drives the price
External providers charge a fixed annual holder fee per authorisation plus project fees for submissions and changes, and external providers pass Swissmedic fees on at cost. External providers do not take a percentage of your Swiss revenue as a default model, because it makes the cost of a slow year unpredictable for both sides.
- Number of authorisations and pack sizes, because each authorisation carries its own annual fee and its own artwork.
- Dispensing category, because category A and B products generate more regulatory and safety work than category D.
- Dossier status in Switzerland: existing authorisation, EU dossier to be adapted, or a full new submission.
- Variation frequency, which for a mature EU product is usually two to six changes per year.
- Whether pharmacovigilance, batch release, import and SL pricing are inside the mandate.
Their pricing model page explains the fee structure in full, including what is billed per hour and what is fixed.
Frequently asked questions
Does the provider own our product if you hold the authorisation?
No. The authorisation is a public law permission, not ownership of the product or the dossier. The contract states that the dossier and the commercial rights are yours, that external providers act on your instructions within the limits of Swiss law, and that external providers transfer the authorisation to you or a party you name on request.
Can you be holder for a product manufactured outside Switzerland?
Yes, and that is the normal case. The holder must have a Swiss domicile; the manufacturing site does not. Import into Switzerland runs under their establishment licence, and their Qualified Person releases each batch for the Swiss market against the manufacturer's documentation.
What happens if Swissmedic inspects the holder?
The inspection takes place at their office in Switzerland, with their Head of Quality and their Head of Regulatory Affairs. External providers keep the Swiss dossier, the technical agreements, the safety documentation and the release records on site, which is exactly what an inspector asks to see. You are informed and receive the report.
Can we appoint you as holder for only one of several products?
Yes. Every authorisation is a separate mandate with its own annual fee. Companies often start with one product to see how the collaboration works before moving a portfolio.
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.