Independent information portal
Planning a Swiss launch without your own local affiliate? Define the authorisation-holder model, retained responsibilities and partner scope before you appoint a provider. Start with your product and your next decision.
Discuss your Swiss market entry
For pharmaceutical companies, biotech teams and product owners
A useful MAH discussion starts with who will own each responsibility. Compare your retained capabilities with the functions you want a Swiss partner to manage, including what happens when the arrangement changes.
Prepare your product status, available dossier and planned launch scope. Discuss the local holder arrangement and the responsibilities your company would retain.
Explore this route: Entering without a Swiss affiliateAsk for a responsibility matrix covering authorisation maintenance, safety, quality and supply interfaces. Identify the contracting entity and any subcontracted work.
Explore this route: Evaluating a local partnerMap the records, contracts, open commitments and continuity needs before discussing a change. Ask how handover and exit responsibilities would be agreed.
Explore this route: Reviewing an existing arrangementUse the evidence in context. Use a written scope when comparing proposals: named responsibilities, evidence of suitability, fees, dependencies, escalation and exit arrangements. This portal receives enquiries; provider appointments are agreed separately.
Tell us whether you are planning your first Swiss launch, comparing local operating models or reviewing an existing arrangement. Detailed qualification can follow the first contact.
Services
Switzerland is not part of the EU single market and not covered by an EU marketing authorisation. Every medicine needs its own Swissmedic authorisation, held by a company with a Swiss domicile. These are the eight functions external providers take over, together or separately.
How onboarding works
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.
External providers look at your dossier, your target dispensing category and your supply chain, then tell you which Swiss procedure fits: full authorisation, an Art. 13 HMG submission using foreign assessment results, simplified authorisation, or a transfer of an existing Swiss authorisation. You get a written scope, a fee estimate and a named contact in Switzerland.
External providers sign a service agreement plus a technical or quality agreement that names who does what: holder duties, pharmacovigilance, batch release, complaints, recalls, product information maintenance. This is the document a Swissmedic inspector asks for first, so external providers write it to be inspected.
External providers build or convert the Swiss part of the dossier: Swiss product information in German, French and Italian, labelling, the Swiss application forms and the electronic submission through Swissmedic's portal. For an existing Swiss authorisation, external providers file the change of holder instead and keep the product supplied throughout.
Once the authorisation is in their name external providers run the yearly duties: variations, renewals, annual fees, pharmacovigilance including ElViS reporting and safety reports, batch release, artwork changes and, if you want it, SL pricing and distribution. You get one quarterly report per product.
Packages
Every product is scoped individually, but the shape of the mandate is usually one of these three. The difference is how much of the Swiss operation you keep and how much external providers own.
External providers hold the authorisation, you keep commercial control
Best for companies with their own distributor in Switzerland who only lack a legal holder.
Get a quoteHolder, safety and quality in one hand
Best for companies without a Swiss quality or safety function, which is most first-time entrants.
Get a quoteExternal providers hold, supply and commercialise
Best for orphan and specialty products where a full Swiss affiliate is not worth building.
Get a quoteExternal providers quote fixed annual fees per product plus an hourly rate for project work, never a share of your revenue as a default. What moves the price: number of products and pack sizes, whether the dossier already exists in Switzerland, the dispensing category, how many variations per year your product generates, whether SL listing and distribution are in scope. Ask for a quote and you get a written fee schedule on a timetable agreed with the selected provider.
Case studies
Illustrative scenarios, not client results
US biotech, orphan drug
Swiss holder for a rare disease product without a Swiss entityEU generics company
Twelve authorisations transferred without a supply gapAsian manufacturer, first Swiss product
From establishment licence question to first deliveryYou need a holder with a Swiss domicile. Art. 10 HMG requires the applicant to have a domicile, a registered office or a branch in Switzerland. Either you found a Swiss entity or you appoint an established Swiss company with the appropriate authorisations as Zulassungsinhaberin. Appointing an existing holder removes the cost of a legal entity, an RPPV, a Qualified Person and a Swiss quality system.
No. Switzerland is not in the EU or the EEA, and neither a centralised EMA authorisation nor a national EU authorisation is valid here. You need a separate Swissmedic authorisation. Art. 13 HMG does require Swissmedic to take account of the assessment results of a foreign authority with comparable controls, which shortens the work but does not replace the Swiss application.
Plan on a first submission in weeks 4 to 12 of a project and then Swissmedic clock time on top. The standard procedure for a new active substance runs to several hundred days of authority time plus your answer time; simplified procedures, procedures using foreign assessment results and changes are much faster. A transfer of an existing authorisation is the quickest route to a Swiss holder.
External providers quote a fixed annual holder fee per product plus project fees for submissions, variations and transfers. The drivers are the number of products and packs, the dispensing category, the dossier status in Switzerland, the number of variations your product generates and whether pharmacovigilance, batch release, SL pricing and distribution are in scope. Swissmedic fees and the annual authorisation fee are charged on at cost.
You do, commercially. The Swissmedic certificate names external MAH providers as holder, and their contract obliges the providers to transfer the authorisation to you or to a third party you name, with their full cooperation and the dossier in a usable format. External providers have run these exits in both directions and they are part of the standard agreement, not a negotiation at the end.
Yes. Listing on the Spezialitätenliste is a separate procedure at the Federal Office of Public Health, not at Swissmedic. External providers prepare the application, build the international price comparison and the therapeutic cross-comparison, defend the price in the review and handle the three-year reviews and the resulting price cuts.
Yes. External providers hold a Swissmedic establishment licence with a named responsible person, so external providers can import and wholesale in Switzerland, and their Qualified Person releases batches for the Swiss market. That means one contract instead of a holder, an importer and a release service.
External providers work in German, English and French. Swiss product information and packaging must be available in German, French and Italian, so external providers commission and control the Italian versions as part of the mandate. Your correspondence with the providers can stay in English throughout.
Send the product, the dossier status and your target date. You get a written scope, a fee schedule and the name of the person who would run your file, on a timetable agreed with the selected provider.
Enquire about Swiss MAH support
Public Swiss sources, independent explanations, and enquiries about external specialist services.
Get a Swiss MAH quote