Swiss RPPV readiness checklist
MAH Switzerland | 2026-09-20

Use this worksheet to identify evidence and ownership gaps before provider selection, launch or inspection preparation.

[ ] 1. Named RPPV and qualified deputy with current contact details

[ ] 2. Qualifications, regular training and command of at least one Swiss official language

[ ] 3. Complete map of Swiss safety intake channels

[ ] 4. ElViS or E2B gateway access and tested submission process

[ ] 5. Written local-global responsibilities and escalation paths

[ ] 6. Reconciliation plan for partners and business functions

[ ] 7. Signal, RMP and product-information change interface

[ ] 8. Provider metrics, audits, deviations and CAPA oversight


Which products, safety-system interfaces and Swiss RPPV responsibilities do you need to establish or review?
https://mahswitzerland.com/en/blog/swiss-pharmacovigilance-rppv/#article-review

Swissmedic: Requirements of 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: Drug Safety Reporting Duties in Switzerland
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/marktueberwachung/mu/mu101_20_004e_mbdrugsafetyreportingdutiesinswitzerland.pdf.download.pdf/mu101_20_004e_mbdrugsafetyreportingdutiesinswitzerland.pdf
Swissmedic: General pharmacovigilance FAQs
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance/faqs/faqs--general-pharmacovigilance.html
Swissmedic: Pharmacovigilance
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html