Product Registration

Workflow steps

1. Product Defined
   Two pathways: full Swissmedic Marketing Authorisation (MA) or cantonal Ausnahmebewilligung (exceptional authorization). Most cannabis in Switzerland is accessed via the exceptional authorization route.
2. MA or Exceptional Auth?
   Full MA provides commercial-scale supply but requires clinical evidence. Cantonal exceptional authorization is used for unregistered products on a per-patient or per-prescriber basis.
3. Full Swissmedic MA — Registered pathway
   Full marketing authorisation via Swissmedic. Requires complete CTD dossier including clinical data. Only Epidyolex holds a Swiss MA as of 2026.
   • Full CTD dossier (Modules 1–5)
   • Swiss-specific Module 1 labeling in DE/FR/IT
   • Clinical data demonstrating efficacy
   • CHF 20,000–100,000+ evaluation fees
   • 12–18 month Swissmedic review
4. Cantonal Ausnahmebewilligung — Exceptional authorization
   Most common pathway. Physician applies to the cantonal health authority for an exceptional authorization to use an unregistered cannabis product for a specific patient or indication.
   • Physician applies per patient or per indication
   • Cantonal authority reviews medical justification
   • BAG (federal) involvement for complex cases
   • Processing: 2–8 weeks depending on canton
5. Swissmedic Dossier Review
   Swissmedic evaluates full CTD. May issue Day 60/120 questions. Clinical Advisory process for novel products.
   • Respond to Swissmedic questions within timeframe
   • German, French, and Italian language labeling required
6. Canton Issues Authorization
   Cantonal health authority issues the Ausnahmebewilligung. Pharmacy can then dispense the specific unregistered product against prescription.
   • Authorization is canton-specific
   • Some cantons issue standing authorizations for a prescriber
   • Other cantons require per-patient applications
7. Swiss MA Granted ✓
   Full Swissmedic registration. Commercial supply possible nationwide. Krankenkasse reimbursement eligibility subject to separate BAG assessment.
8. Cantonal Supply Active ✓
   Supply to specific cantonal pharmacies for specific patients under exceptional authorization. Cantonally limited — each canton requires separate authorization.