Swiss MAH partner due-diligence checklist
MAH Switzerland | 2026-09-20

Record the evidence, date and reviewer for each item before making a partner decision.

[ ] 1. Define the required mandate and separate mandatory from optional functions.

[ ] 2. Verify the exact legal entity, Swiss presence, licensed activities and sites.

[ ] 3. Meet the named RP, RPV, deputies and regulatory lead.

[ ] 4. Test quality, PV and recall governance with practical scenarios.

[ ] 5. Confirm dossier, safety, quality and batch-record access and ownership.

[ ] 6. Map importer, market release, storage, distribution and customer flow.

[ ] 7. Screen product and portfolio conflicts and decision independence.

[ ] 8. Agree audit, subcontracting, transition and transfer-out rights.


Which Swiss MAH functions, licence activities and operating interfaces must your partner cover?
https://mahswitzerland.com/en/blog/choosing-a-swiss-mah-partner/#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