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GMP Pathway

EU-GMP requirements for the Italian market

GMP Verified 2026-04-20

Workflow steps

  1. GMP Assessment
    Italy is an EU/EEA member. AIFA issues EU-GMP certificates. EU-GMP Part I required for all imported medicinal cannabis. SCFM operates under Italian GMP (BPF) for domestic production.
  2. EU-GMP Part I Required — Mandatory for imported products
    All finished medicinal cannabis imported into Italy must be manufactured under EU-GMP Part I. SCFM's domestic production operates under Italian GMP (BPF — Buone Pratiche di Fabbricazione).
    • EEA or PIC/S certificate with cannabis scope
    • Certificate must be current at time of import
    • SCFM domestic: Italian BPF compliance
  3. AIFA GMP Certification
    AIFA issues EU-GMP certificates for Italian manufacturers. All EEA + PIC/S certificates accepted for import purposes. SCFM operates under Italian GMP (BPF) for domestic production of FM2 cannabis flos.
    • AIFA-issued EU-GMP certificate (for Italian manufacturers)
    • EEA or PIC/S certificate (for imports)
    • Cannabis manufacturing scope explicitly stated
  4. QP Release
    EU QP certifies batch for Italian market release. QP named on Italian importer's wholesale authorization.
    • QP named on Italian wholesale authorization
    • Full batch record reviewed
    • QP signature on batch certificate
  5. Released for Italian Market ✓
    QP-certified cannabis available for distribution to pharmacies via SSN or private supply.
Import AuthorizationProduct Registration