At a glance
A Swiss marketing authorisation holder, or MAH, is the legal holder of a medicine's Swiss authorisation. It must meet the Swiss presence and establishment-licence conditions that apply to its model, maintain the authorisation, govern safety and quality, and ensure Swiss market release and surveillance. Defined work can be contracted to qualified parties, but contracts do not remove the MAH's overall accountability. Reimbursement remains a separate decision by the Federal Office of Public Health.
Key takeaways
- A product authorisation and an establishment licence are different legal objects, and a workable MAH model needs both to align.
- Outsourcing can move tasks, systems and physical operations, but it does not automatically transfer the holder's regulatory accountability.
- The market-release RP and the pharmacovigilance RPV are different roles with different decisions, deputies and evidence.
- A manufacturer should inspect the exact legal entity, licence scope, named people, agreements, data access and exit plan before appointment.
What makes an entity eligible to hold a Swiss authorisation?
The Therapeutic Products Act links a marketing authorisation application to three things: evidence that the medicine is of high quality, safe and effective, the relevant authorisation to manufacture, import or conduct wholesale trade, and a registered address, registered office or branch in Switzerland. A Swiss mailbox or a sales representative alone does not satisfy that combined test.
The product authorisation answers whether a named medicine may be marketed under approved conditions. The establishment licence answers whether the legal entity may perform defined activities at specified sites. A prospective holder therefore needs a licence scope that fits the intended import, wholesale and market-release model, not merely a group company that appears to be Swiss.
Which responsibilities sit inside the MAH operating model?
The holder connects regulatory lifecycle work with pharmacovigilance, quality, market release, supply oversight and market surveillance. Pricing and reimbursement influence the launch plan, but Swissmedic authorisation does not itself place a product on the Specialities List. That separate FOPH workstream should have its own owner and evidence plan.
The table is a planning map, not a substitute for the applicable law, licence or product decision. For each row, identify the accountable legal entity, the person who makes the decision, the contractor who performs the work and the record that proves it happened.
| Area | Operations that may be contracted | What the MAH must govern | Evidence to inspect |
|---|---|---|---|
| Regulatory lifecycle | Dossier preparation and submission support | Accuracy, completeness, approved terms and change control | Regulatory agreement, dossier access and submission history |
| Pharmacovigilance | Case processing, systems and an external RPV where suitable | Overall PV responsibility, oversight and Swiss reporting readiness | RPV and deputy, PV agreement, QMS, metrics and escalation |
| Quality and distribution | Storage and distribution by licensed parties | Product integrity, traceability, complaints and recall readiness | Licence scope, quality agreement, GDP evidence and recall test |
| Swiss market release | Document collection and physical pre-wholesaler activities | Final release decision and responsibility for released batches | MAH scope, named RP, release SOP and batch record |
| Reimbursement | Evidence development and application support | Commercial strategy and truthful, controlled evidence | FOPH plan, decision rights and approved claim set |
What can be outsourced, and what remains with the holder?
A holder may contract defined activities when the parties have the necessary licences and competence. The safe working rule is that the agreement must state responsibilities, records, access rights, oversight, deviations, escalation and business continuity. The holder needs enough information and authority to make the decisions that Swiss law and its licence place on it.
Swissmedic's current market-release interpretation allows physical operations to be performed with an appropriately licensed pre-wholesaler, but requires a quality agreement, oversight and a risk-based contractor assessment. The final market-release decision and recall responsibility remain with the MAH. Current RPV guidance follows the same governance logic: the RPV role and PV tasks may be external, while the MAH retains overall PV responsibility.
How do the RP, RPV and EU QP differ?
The Responsible Person, often called the FvP in German, is tied to the establishment licence. Where the holder has market-release scope, this RP makes the Swiss market-release decision. The Responsible Person for Pharmacovigilance, or RPV, governs the Swiss PV notification system and needs a qualified deputy. These are separate responsibilities and should not be assigned or described as one generic responsible-person role.
An EU Qualified Person certificate can be important evidence in the batch package, but it does not by itself replace the Swiss MAH's market-release decision. Likewise, an EU QPPV arrangement does not automatically demonstrate a working Swiss RPV model. The partner file should show the Swiss role, availability, language capability, deputy, interfaces and oversight.
What evidence should a manufacturer verify before appointment?
Start with the exact legal name that would contract and hold the authorisation. Check its current SwissGMDP record, relevant sites and activity scope. Public licence data is useful evidence of published status, but it does not prove capacity, service quality, product experience or freedom from conflicts.
Then inspect the operating evidence: named RP, RPV and deputy; regulatory and quality agreements; dossier and safety-data access; subcontractor map; deviation, complaint and recall processes; performance review; audit rights; and a practical transfer-out clause. Ask who can act when the primary contact is absent and who has final authority when commercial priorities conflict with safety or quality.
- Match the legal entity in the proposal to the entity shown in official records.
- Confirm that licence activities and sites fit the planned physical supply chain.
- Request named role holders, deputies and evidence of organisational access.
- Trace each retained decision to an SOP, agreement and record owner.
- Confirm that your company can retrieve its dossier, safety and quality records on exit.
How should a company design the mandate?
Begin with the product and route, then draw the legal and physical flows separately. Decide who holds the authorisation, which establishment-licence activities are needed, who is RP and RPV, where the dossier and safety system sit, and how batches reach Swiss customers. Only then decide whether one provider or several specialised parties should perform the work.
Our suggested method is to turn that map into a responsibility schedule with one accountable owner, one backup and one evidence record for every critical decision. This is a planning method, not a regulatory rule. It makes gaps visible before contracts are signed and gives a qualified Swiss specialist a focused brief to review.
MAH / CH
Swiss MAH operating-model checklist
Use this worksheet to prepare a focused, non-confidential discussion with a qualified Swiss specialist.
- Name the exact legal entity proposed as authorisation holder.
- Verify Swiss presence and the relevant establishment-licence activities and sites.
- Assign the regulatory dossier owner and confirm complete source-document access.
- Name the RP, RPV and qualified backups, and document their authority.
- Map Swiss market release, import, storage, distribution and recall responsibilities.
- Define agreements, oversight, metrics, deviations and escalation routes.
- Set dossier, safety, quality and batch-record handover requirements for exit.
- Decide whether SL reimbursement is needed and assign it as a separate workstream.
Continue exploring
MAH holdingQuestions before your next step
Can a company outside Switzerland hold a Swiss marketing authorisation directly?
The applicant must meet the Swiss presence and relevant establishment-licence conditions in TPA Art. 10. A foreign sponsor therefore needs a qualifying Swiss legal and licensing model, whether through its own eligible presence or a separately contracted holder. The right model depends on the activities and supply chain.
Can the Swiss MAH outsource regulatory, PV and logistics work?
Defined activities can be contracted to competent and, where required, licensed parties under written responsibilities and oversight. Outsourcing does not erase the holder's overall responsibility, and certain decisions, including final Swiss market release in the applicable model, remain with the MAH.
Is the RPV the same role as the batch-release RP?
No. The RPV is responsible for the pharmacovigilance system, while the RP or FvP is tied to the establishment licence and relevant technical decisions. The roles need separate qualifications, authority, backup and documentation even if one qualified person or organisation supports both.
Does a Swiss MAH also need to be the importer or distributor?
Not necessarily. Import, storage and distribution can involve other appropriately licensed entities. The complete model must still show who holds each licence scope, who makes Swiss market release, how records flow and how the MAH oversees quality, traceability and recalls.
Does Swissmedic authorisation include reimbursement?
No. Swissmedic decides on the medicine's authorisation. Routine outpatient reimbursement through compulsory health insurance is a separate FOPH decision involving the Specialities List, any limitation and the maximum reimbursed price.
Sources and further reading
- Federal Act on Medicinal Products and Medical Devices
- Ordinance on Licensing in the Medicinal Products Sector
- SwissGMDP public database
- Swissmedic requirements for the Responsible Person for Pharmacovigilance
- Swissmedic: market release with a pre-wholesaler
- FOPH: prices of medicines and the Specialities List
Independent editorial information for business planning. This is not regulatory or legal advice. Current official guidance prevails; any external specialist introduction is discussed with you first. Please do not send patient data or confidential dossiers.
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