GMP Pathway

Workflow steps

1. GMP Assessment
   Spain is an EU/EEA member. AEMPS is a major EU-GMP issuing authority. EU-GMP Part I required for all medicinal cannabis imports.
2. EU-GMP Part I Required — Mandatory for finished product
   All finished cannabis imported into Spain must be manufactured under EU-GMP Part I. Certificate from any EEA or PIC/S authority accepted.
   • EEA or PIC/S certificate with cannabis scope
   • Certificate must be current at time of import
3. AEMPS GMP Certification
   AEMPS is a major EU-GMP issuing authority. All EEA + PIC/S certificates accepted for import purposes. AEMPS issues its own EU-GMP certificates for domestic manufacturing.
   • AEMPS-issued EU-GMP certificate (for Spanish manufacturers)
   • EEA or PIC/S certificate (for imports)
   • Cannabis manufacturing scope explicitly stated
4. QP Release
   EU QP certifies batch for Spanish market release. QP named on Spanish importer's wholesale authorization.
   • QP named on Spanish wholesale authorization
   • Full batch record reviewed
5. Released for Spanish Market ✓
   QP-certified cannabis available for supply to compounding pharmacies (Fórmula Magistral).