JurisdictionsTopicsUpdatesWorkflowsCompareChat with ExpertMarketplacePricing
🇩🇪📋

Import Authorization

BtMG §3 per-shipment authorization process from BfArM

Import / Export Verified 2026-04-20

Workflow steps

  1. Import Intent
    You wish to import medical cannabis into Germany as a licensed BtMG §3 importer.
    • Valid BtMG §3 importer license from BfArM
    • Registered business address in Germany
  2. EU-GMP Part I?
    Does the manufacturing site hold a current EU-GMP Part I certificate from an EEA or PIC/S recognized authority?
  3. Direct Import Path — Finished product
    Manufacturing site holds EU-GMP Part I. You may import finished product directly to German pharmacies.
    • EU-GMP Part I certificate (current, cannabis scope)
    • GACP certificate for cultivation site
    • QP at importing entity to certify batches
  4. API / Bulk Path — EU-GMP Part II
    Supply bulk API to a German AMG §13 licensed manufacturer who finishes the product under Part I.
    • EU-GMP Part II certificate
    • Signed agreement with German finisher
    • German finisher's QP takes release responsibility
  5. Prepare Application
    Compile all documentation required for the BfArM per-shipment authorization.
    • EU-GMP & GACP certificates
    • Certificate of Analysis (COA) per batch
    • Product specs and HS code 1211.90
    • Exporting country export authorization
  6. Submit via BfArM Portal
    Online submission through BfArM narcotics portal. One application per shipment — no blanket authorizations.
  7. BfArM Review (~5 wks)
    Average processing time reduced from 8 to ~5 weeks (Feb 2026). Queries from BfArM pause the clock.
    • Respond to BfArM queries within 30 days
    • Response resets review clock to ~5 weeks
  8. Approved?
    BfArM issues or denies the import authorization. Denials must state reasons in writing.
  9. Address Deficiencies
    Respond in writing to each BfArM deficiency point and resubmit amended application.
    • Written response to each deficiency point
    • Resubmission resets review clock
  10. Authorization Issued
    Per-shipment authorization valid only for the specified quantity, supplier, and product.
    • Keep original — required at customs
    • Lapses if shipment not completed in validity period
  11. Customs at FRA / Hamburg
    Present original BtMG authorization at entry point. BtMG import declaration required under Single Convention 1961.
    • Original import authorization
    • All shipping docs + COA
  12. Shipment Cleared ✓
    Delivered to licensed German importer. QP must certify each batch before pharmacy distribution.
Regulatory Hierarchy