GMP Pathway

Workflow steps

1. GMP Assessment
   Luxembourg is an EEA member. EU-GMP Part I required for all medicinal cannabis imports. EEA and PIC/S certificates accepted.
2. EU-GMP Part I Required — Mandatory for finished product
   All finished cannabis imported into Luxembourg must be manufactured under EU-GMP Part I. Certificate from any EEA or PIC/S authority accepted.
   • EEA authority EU-GMP Part I certificate
   • Cannabis manufacturing scope explicitly stated
   • Certificate must be current at time of import
3. EEA + PIC/S Certificates Accepted
   All EEA-issued EU-GMP certificates accepted. PIC/S member certificates (TGA Australia, Health Canada, MHRA UK, etc.) also recognized.
   • EEA or PIC/S member GMP certificate
   • Cannabis manufacturing scope stated
   • QP at Luxembourg importer certifies batches
4. QP Release
   EU QP certifies batch for Luxembourg market release.
   • QP named on Luxembourg wholesale authorization
   • Full batch record reviewed
5. GMP Pathway Cleared ✓
   GMP requirements satisfied. Proceed to import authorization application.