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GMP Pathway

EU-GMP requirements for the Portuguese market

GMP Verified 2026-04-20

Workflow steps

  1. GMP Assessment
    Portugal is an EU/EEA member. INFARMED is an EEA authority — issues EU-GMP Part I certificates. Portuguese EU-GMP certificates are directly accepted across EU.
  2. Domestic production or import?
    Domestic production requires GACP + EU-GMP Part I from INFARMED. Imports require EEA or PIC/S certificate.
  3. GACP + EU-GMP Part I — Domestic production
    INFARMED issues separate GACP (cultivation) and GMP (processing) licenses. Climate advantage for outdoor cultivation. INFARMED EU-GMP certificates directly accepted across EU.
    • INFARMED GACP cultivation license
    • INFARMED EU-GMP Part I manufacturing license
    • Cannabis scope explicitly stated
  4. EEA / PIC/S Certificate — Import pathway
    Certificate from any EEA competent authority or PIC/S-recognised body accepted for imports into Portugal.
    • EEA authority or PIC/S certificate
    • Cannabis scope explicitly stated
    • Certificate must be current at time of import
  5. EU QP Batch Release
    All batches released to the Portuguese market must be certified by an EU Qualified Person.
    • QP named on Portuguese wholesale authorization
    • Full batch record reviewed
    • QP signature on batch certificate required
  6. Released for Portuguese Market ✓
    QP-certified batch available for distribution to pharmacies and hospitals.
Export / Import ProcessCultivation Licensing