Swiss MAH operating-model checklist
MAH Switzerland | 2026-09-20

Use this worksheet to prepare a focused, non-confidential discussion with a qualified Swiss specialist.

[ ] 1. Name the exact legal entity proposed as authorisation holder.

[ ] 2. Verify Swiss presence and the relevant establishment-licence activities and sites.

[ ] 3. Assign the regulatory dossier owner and confirm complete source-document access.

[ ] 4. Name the RP, RPV and qualified backups, and document their authority.

[ ] 5. Map Swiss market release, import, storage, distribution and recall responsibilities.

[ ] 6. Define agreements, oversight, metrics, deviations and escalation routes.

[ ] 7. Set dossier, safety, quality and batch-record handover requirements for exit.

[ ] 8. Decide whether SL reimbursement is needed and assign it as a separate workstream.


Which Swiss MAH, regulatory, PV, quality or supply responsibilities do you still need to assign?
https://mahswitzerland.com/en/blog/swiss-mah-roles-responsibilities/#article-review

Federal Act on Medicinal Products and Medical Devices
https://www.fedlex.admin.ch/eli/cc/2001/422/en
Ordinance on Licensing in the Medicinal Products Sector
https://www.fedlex.admin.ch/eli/cc/2018/786/en
SwissGMDP public database
https://swissgmdp.ch/
Swissmedic requirements for the Responsible Person for Pharmacovigilance
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/marktueberwachung/abrenzungsfragen/mu100_00_001d_wl_anforderungen_pharmakovigilanz_verantwortliche_person.pdf.download.pdf/MU100_00_001e_WL_Requirements_of_the_Responsible_Person_for_PV.pdf
Swissmedic: market release with a pre-wholesaler
https://www.swissmedic.ch/dam/swissmedic/fr/dokumente/bewilligungen/inspektorat/i-smi_ti_06e_marketreleaseanddistributionincooperationwithapre-w.pdf.download.pdf/i-smi_ti_06e_marketreleaseanddistributionincooperationwithapre-w.pdf
FOPH: prices of medicines and the Specialities List
https://www.bag.admin.ch/en/prices-of-medicines-in-switzerland-faqs