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Import Authorization

AEMPS import authorization for pharmaceutical-grade cannabis

Import / Export Verified 2026-04-20

Workflow steps

  1. Import Intent
    Spain imports pharmaceutical-grade cannabis for magistral preparation (FΓ³rmula Magistral). Authorized importers bring in cannabis under AEMPS authorization per shipment. EU-GMP Part I required β€” Spain is EEA; AEMPS issues EU-GMP certificates.
    • AEMPS import authorization per shipment
    • Spanish licensed importer (wholesale authorization)
    • EU-GMP Part I mandatory
  2. Apply: AEMPS Import Authorization
    Per-shipment import authorization from AEMPS. Processing: approximately 4–6 weeks. Importer must hold AEMPS wholesale authorization.
    • EU-GMP Part I certificate
    • GACP certificate
    • COA per batch
    • Exporting country export authorization
    • AEMPS wholesale authorization
  3. Authorization granted?
    AEMPS reviews and issues or requests clarification. May require additional product documentation.
  4. Spanish Customs Entry
    EU customs procedures apply. Pharmaceutical-grade cannabis cleared for delivery to authorized importer.
    • AEMPS import authorization (original)
    • All shipping documentation
    • EU customs narcotic declaration
  5. Cleared for Magistral Preparation βœ“
    Pharmaceutical-grade cannabis released to authorized importer for supply to compounding pharmacies.
Regulatory HierarchyGMP Pathway