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Regulatory Hierarchy

Swiss federal and cantonal regulatory structure

Regulatory Structure Verified 2026-04-20

Workflow steps

  1. Swissmedic β€” Swiss Medicines Agency
    Federal Institute for Medicinal Products and Medical Devices. Issues marketing authorizations, wholesale licenses, GMP inspections. Swiss GMP is PIC/S-aligned.
    • Marketing Authorizations (MA)
    • Wholesale dealer authorizations
    • GMP inspections β€” Swissmedic certificates accepted by EU, UK, MHRA
    • Exceptional authorizations for unregistered products
  2. fedpol β€” Federal Office of Police
    Issues all narcotic licenses and per-shipment import/export permits under the Swiss Narcotics Act (BetmG). Separate from Swissmedic β€” both agencies required for cannabis.
    • Annual narcotic handling licenses
    • Per-shipment import and export permits
    • Compliance with Single Convention 1961
    • INCB reporting
  3. BAG / OFSP β€” Federal Office of Public Health
    Bundesamt fΓΌr Gesundheit. Oversees national health policy including cannabis access policy. Issues exceptional authorizations for medical use in complex cases.
    • National cannabis policy
    • Cantonal exceptional authorization oversight
    • Patient access policy
  4. Cantonal Health Authorities β€” 26 cantonal authorities
    Each Swiss canton has its own health authority. Cantonal exceptional authorizations (Ausnahmebewilligungen) are issued for unregistered medicinal cannabis. Requirements vary between cantons β€” Zurich, Geneva, and Basel are most active.
    • Cantonal exceptional authorization per patient/prescriber
    • Cantonal pharmacy oversight
    • Cantonal narcotic registry
  5. Kantonale Apothekerverband β€” Cantonal pharmacy associations
    Each canton has a pharmacy association overseeing dispensing standards. Pharmacies must comply with cantonal and federal requirements simultaneously.
    • Cantonal pharmacy license
    • Federal narcotic dispensing rules
    • BetmG register maintenance
  6. Licensed Pharmacies β€” Dispensing
    Dispense against physician prescriptions under cantonal and federal oversight. Narcotic dispensing register maintained. Cantonal exceptional authorizations required for non-registered cannabis products.
    • Cantonal pharmacy license
    • BetmG narcotic register
    • Exceptional authorization from cantonal authority for unregistered products
  7. Patients β€” End recipients
    Receive cannabis via physician prescription. Cantonal exceptional authorization required if product is unregistered. Health insurance (Krankenkasse) coverage for cannabis is limited β€” primarily out of pocket.
Import AuthorizationGMP Pathway