Swiss authorisation transfer readiness checklist
MAH Switzerland | 2026-09-20

Use this worksheet to identify owners and evidence before selecting a transfer date.

[ ] 1. Classify the corporate event and confirm the Swissmedic route.

[ ] 2. Verify future-holder eligibility, licence scope, RP and RPV readiness.

[ ] 3. Prepare the current form, assignment evidence and filing plan.

[ ] 4. Inventory the dossier, eCTD lifecycle and regulatory correspondence.

[ ] 5. Reconcile PV cases, signals, commitments, systems and vendor records.

[ ] 6. Classify batches, market-release status, stock, packaging and artwork.

[ ] 7. Map supply, complaints, recalls, returns and customer records.

[ ] 8. Transfer FOPH and Specialities List records where relevant and approve the cutover gate.


What legal event, products, current holder, future holder and target window are you planning?
https://mahswitzerland.com/en/blog/swiss-authorisation-transfer/#article-review

Swissmedic guidance: Transfer of marketing authorisation
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl404_00_001d_wluebertragungderzulassung.pdf.download.pdf/ZL404_00_001e_wluebertragungderzulassung.pdf
Swissmedic questions and answers on authorisation transfer
https://www.swissmedic.ch/swissmedic/en/home/services/documents/faq-uebertragung-zl-orphan-drug-status.html
Swissmedic guidance: Change of name or domicile
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/bw/bw303_00_003d_wlaenderungvonnameoderdomizilderzulassungsinhaberi.pdf.download.pdf/bw303_00_003d_wlaenderungvonnameoderdomizilderzulassungsinhaberi.pdf
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
Federal Office of Public Health: Prices of medicines in Switzerland
https://www.bag.admin.ch/en/prices-of-medicines-in-switzerland-faqs