Swiss dossier-readiness worksheet
MAH Switzerland | 2026-09-20

Use this planning checklist to prepare a focused review without sending confidential dossier content.

[ ] 1. Frozen product, application type, indication and Swiss route hypothesis

[ ] 2. Eligible Swiss applicant and proposed authorisation holder

[ ] 3. Technically validated eCTD with complete accessible sequence history

[ ] 4. Swiss Module 1 forms, declarations and route evidence

[ ] 5. Reconciled product information, packaging and translation sources

[ ] 6. Reference decision, assessment report and post-decision change chronology

[ ] 7. Manufacturer, testing site, GMP and supply-chain consistency matrix

[ ] 8. Named owners for quality, clinical, safety and lifecycle gap closure


What is the product type, current authority decision, eCTD sequence status, intended Swiss route and largest known gap?
https://mahswitzerland.com/en/blog/swiss-authorisation-dossier/#article-review

Swissmedic: eCTD submissions
https://www.swissmedic.ch/swissmedic/en/home/services/submissions/ectd.html
Swissmedic: Formal requirements for authorisation applications
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_020d_wlformaleanforderungen.pdf.download.pdf/zl000_00_020d_wlformaleanforderungen.pdf
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: Information on packaging
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/zl000_00_021d_wl_wegleitung_angaben_auf_packmittel.pdf.download.pdf/ZL000_00_021e_WL%20Guidance%20document%20Information%20on%20packaging.pdf
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
Swissmedic: SwissGMDP database
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/bewilligungen_zertifikate/authorisations/swissgmdp.html
Swiss Confederation: Therapeutic Products Act, SR 812.21
https://www.fedlex.admin.ch/eli/cc/2001/422/en
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