MAH services for the Swiss market
Public Swiss sources, independent explanations, and enquiries about external specialist services.
Which services does a Swiss Marketing Authorisation Holder cover?
A Swiss MAH service covers eight functions: holding the authorisation, transferring it, regulatory maintenance, pharmacovigilance, quality assurance and batch release, import and wholesale, pricing and reimbursement, and commercialisation. Swiss law attaches most of these duties to the holder, which is why they are usually bought together.
The legal starting point is Art. 10 of the Therapeutic Products Act (HMG): whoever applies for an authorisation must have a domicile, a registered office or a branch in Switzerland. Everything else follows from that one sentence. The holder signs the application, receives the Swissmedic decision, pays the annual fee, answers for the product information, reports adverse reactions and is the address a Swiss inspector writes to.
What is a Marketing Authorisation Holder in Switzerland?
The Marketing Authorisation Holder, in German Zulassungsinhaberin, is the company named on the Swissmedic authorisation certificate. It is legally responsible for the authorised medicine in Switzerland: for the accuracy of the dossier, for the product information, for pharmacovigilance, for defect and recall handling and for the annual authorisation fee. It does not have to be the manufacturer or the owner of the product.
The eight functions in detail
Each function below is a separate page with the process, the deliverables, the Swiss legal basis and the timelines external providers plan with. Mandates usually start with holding plus pharmacovigilance, because those two are the duties a foreign company cannot fulfil from abroad.
| Service | Replaces | Swiss legal anchor |
|---|---|---|
| MAH holding | A Swiss legal entity and a regulatory head | Art. 10 and Art. 11 HMG, VAM |
| Authorisation transfer | An in-house project for the change of holder | Change requiring Swissmedic approval |
| Regulatory affairs | A Swiss regulatory affairs manager | Art. 16 and Art. 16b HMG, VAM |
| Pharmacovigilance | A Swiss RPPV and a safety database process | Art. 59 HMG, VAM, ElViS |
| QA and batch release | A Qualified Person and a Swiss quality system | AMBV, GMP annexes, technical agreement |
| Import and wholesale | Your own Swissmedic establishment licence | Art. 18 and Art. 28 HMG, AMBV |
| Pricing and reimbursement | A Swiss market access manager | KVG, KVV, KLV, FOPH SL procedure |
| Commercialisation and CCO | A Swiss affiliate with sales and logistics | Contractual, plus GDP for distribution |
How the services fit together over a product life cycle
In the first year the work is regulatory: classification, dossier, product information in three languages, submission, approval. From year two on it becomes maintenance: variations when the EU dossier changes, the five-year renewal, annual fees, safety reports, batch release for every import and the three-year SL price review.
- Before submission. Classification, procedure choice, gap analysis against the Swiss requirements, fee estimate.
- Submission. Swiss forms, product information in German, French and Italian, labelling, electronic submission, answers to Swissmedic questions.
- Approval to first delivery. Artwork, import, batch release, wholesaler set-up, optional SL application.
- Steady state. Variations, renewals, pharmacovigilance, quality events, annual fees, price reviews, quarterly reporting to you.
- Exit or handover. Transfer of the authorisation back to you or to a buyer, with the dossier and the safety documentation.
Why buy this instead of building it
A Swiss affiliate that can legally hold an authorisation needs a registered entity, a regulatory function, a Responsible Person for Pharmacovigilance reachable in Switzerland, a quality system and, if you import, an establishment licence with a responsible person. For one to five products that is a permanent cost against a small market of nine million people.
- No Swiss entity, no local employment contracts, no office.
- Verify the qualifications, appointment and responsibilities of the Qualified Person, GMP/GDP auditor and RPPV before contracting.
- Their establishment licence covers your import and wholesale.
- Public Swiss sources, independent explanations, and enquiries about external specialist services.
- One contract, one quarterly report, one invoice per product.
Frequently asked questions
Can we buy only one of these services?
Yes. The most frequent single mandates are pharmacovigilance with a Swiss RPPV, and an authorisation transfer. The one combination external providers do not offer is holding an authorisation without pharmacovigilance, because the holder carries the reporting duty under Art. 59 HMG and external providers will not sign for a duty external providers cannot control.
Do you work with medical devices as well?
Their core business is medicinal products under the HMG. Medical devices follow the Medical Devices Ordinance (MepV) and need a Swiss authorised representative, the CH-REP, which is a different legal role from a Marketing Authorisation Holder. For devices external providers point you to the CH-REP guidance in their network rather than pretend the two are interchangeable.
Who talks to Swissmedic, you or we?
External providers do, in the holder's name, and you are copied on everything. Swissmedic correspondence is in German or French; external providers translate the substance into English for you and answer within the deadlines set in the letter.
How quickly can you take over an existing portfolio?
For a portfolio of Swiss authorisations that already exist, the limiting factor is the change of holder at Swissmedic, not the providers. External providers can have the contract and the quality agreement signed within two to four weeks and file the transfers as a single project.
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.