EU-to-Switzerland gap checklist
MAH Switzerland | 2026-09-20

Use this worksheet to prepare a focused route discussion without sending a confidential dossier.

[ ] 1. Exact EU procedure, decision and current assessment report

[ ] 2. Swiss route hypothesis and Article 13 comparability check

[ ] 3. Eligible Swiss applicant and holder model

[ ] 4. Swiss Module 1 and eCTD lifecycle gap list

[ ] 5. German, French and Italian product-information plan

[ ] 6. Swiss RPV, deputy and safety-system interfaces

[ ] 7. Importer, market-release RP and distribution map

[ ] 8. Separate FOPH reimbursement and pricing strategy


What is the exact EU decision, intended Swiss route, target filing date and largest unresolved Swiss gap?
https://mahswitzerland.com/en/blog/swissmedic-vs-ema/#article-review

Swiss Confederation: Therapeutic Products Act, SR 812.21
https://www.fedlex.admin.ch/eli/cc/2001/422/en
Swissmedic: Authorisation under Article 13 TPA
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_019d_vvanleitungzulassungimauslandbereitszugelassenerhu.pdf.download.pdf/ZL000_00_019e_WL%20Guidance%20document%20Authorisation%20human%20medicine%20under%20Art%2013%20ATP.pdf
European Medicines Agency: Obtaining an EU marketing authorisation
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step
Swissmedic: Product information for human medicinal products
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_027d_wlarzneimittelinformation.pdf.download.pdf/zl000_00_027e_wlarzneimittelinformation.pdf
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
Federal Office of Public Health: Prices of medicines in Switzerland
https://www.bag.admin.ch/en/prices-of-medicines-in-switzerland-faqs