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Import Authorization

HPRA import authorization for medicinal cannabis into Ireland

Import / Export Verified 2026-04-20

Workflow steps

  1. Import Intent
    Ireland is an import-only country — no domestic commercial cannabis cultivation permitted. All medicinal cannabis must be imported under HPRA authorization. Ireland is EEA; EU-GMP Part I is mandatory.
    • HPRA import authorization per shipment
    • Irish-licensed wholesale dealer as sponsor
    • EU-GMP Part I certificate mandatory
  2. Apply: HPRA Import License
    Per-shipment import authorization from HPRA. Processing: approximately 4–6 weeks. Application must include product details, GMP certificates, and exporting country authorization.
    • EU-GMP Part I certificate (cannabis scope)
    • GACP certificate
    • COA per batch
    • Exporting country export authorization
    • Irish licensed importer as sponsor
  3. Authorization granted?
    HPRA reviews and issues or requests additional information. Common issues: GMP certificate scope, product not on MCAP-approved list, or documentation gaps.
  4. Address HPRA Queries
    Respond to HPRA in writing. Ensure all documentation meets HPRA standards and GMP certificate scope covers cannabis manufacturing.
    • Updated certificates if flagged
    • Product specification clarification
    • Irish-language labeling not required — English accepted
  5. Customs / Entry
    Dublin Airport (DUB) or Cork Airport (ORK) are primary pharmaceutical entry points. EU customs procedures apply. Misuse of Drugs declaration required.
    • HPRA import authorization (original)
    • Misuse of Drugs import declaration
    • All shipping documentation + COA
  6. Cleared for Irish Market ✓
    Released to licensed Irish importer. QP certification required before supply to pharmacies.
Regulatory HierarchyGMP Pathway