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Import Authorization

SÚKL import authorization process for medicinal cannabis

Import / Export Verified 2026-04-20

Workflow steps

  1. Import Intent
    You intend to import medicinal cannabis into the Czech Republic. SÚKL (State Institute for Drug Control) manages import authorizations. Czech Republic is an EU member — EU-GMP Part I required.
    • SÚKL import authorization per shipment
    • Czech licensed importer / wholesale dealer
    • EU-GMP Part I certificate mandatory
  2. Hold Czech Importer License
    Czech entity must hold a SÚKL wholesale dealer license and a Ministry of Health narcotic handling authorization.
    • SÚKL wholesale authorization
    • MOH narcotic handling license
    • GDP-compliant storage facility in Czech Republic
  3. Apply: SÚKL Import Authorization
    Per-shipment import authorization from SÚKL. Application includes product specs, GMP/GACP certificates, and exporting country authorization.
    • EU-GMP Part I certificate (cannabis scope)
    • GACP certificate
    • COA per batch
    • Exporting country export authorization
    • Processing: approximately 3–5 weeks
  4. Authorization granted?
    SÚKL reviews application. Common issues: GMP certificate scope, Czech-language labeling requirements, or GACP currency.
  5. Address SÚKL Queries
    Respond to SÚKL in writing. Czech-language product labeling frequently flagged — ensure SÚKL-compliant labeling.
    • Czech-language product labeling
    • Updated certificates if required
  6. Authorization Issued
    Per-shipment authorization issued. Valid for specific product, quantity, and supplier.
    • Original required at Czech customs
    • Prague Ruzyně (PRG) is primary air entry point
  7. Czech Customs Entry
    Customs clearance at Prague airport or land border. Narcotic import declaration under Single Convention 1961.
    • SÚKL authorization (original)
    • All shipping docs + COA
    • Narcotic declaration filed
  8. Shipment Cleared ✓
    Released to licensed Czech importer. QP certification required before distribution to pharmacies.
Regulatory Hierarchy