Swiss pharmaceutical market-entry working checklist
MAH Switzerland | 2026-09-20

Use this planning worksheet to identify evidence and owners before fixing a submission or launch date.

[ ] 1. Classify the product and document the proposed Swissmedic pathway.

[ ] 2. Confirm the foreign decision, assessment report and complete current dossier lifecycle.

[ ] 3. Select the exact Swiss holder entity and verify its establishment licence scope.

[ ] 4. Map Swiss Module 1, product information, packaging and translation gaps.

[ ] 5. Appoint the RPV and deputy and document global-to-Swiss PV interfaces.

[ ] 6. Draw the technical release, Swiss market release, import, storage and distribution flow.

[ ] 7. Define whether SL reimbursement is required and when FOPH work should start.

[ ] 8. Create a documented launch gate with accountable owners and unresolved risks.


Which Swiss market-entry decision is currently blocking your plan?
https://mahswitzerland.com/en/blog/swiss-pharma-market-entry/#article-review

Swiss Confederation: Therapeutic Products Act, SR 812.21
https://www.fedlex.admin.ch/eli/cc/2001/422/en
Swissmedic: Authorisation of human medicinal products 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
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: Market release and distribution 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
Federal Office of Public Health: Prices of medicines in Switzerland
https://www.bag.admin.ch/en/prices-of-medicines-in-switzerland-faqs
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