GMP Pathway

Workflow steps

1. GMP Assessment
   Malta is an EU member. EU-GMP Part I required for all finished medicinal cannabis. Medicines Authority participates in EU GMP inspection network.
2. EU-GMP Part I Required
   Mandatory for all finished medicinal cannabis imported into Malta. EEA or PIC/S certificate required.
   • EEA authority or PIC/S certificate
   • Cannabis manufacturing scope explicitly stated
   • QP at Maltese importer certifies batches
3. MMCA — Industrial Export
   For Maltese manufacturers exporting, MMCA sets quality standards. MMCA exports must meet destination country GMP requirements.
   • MMCA quality standards for export product
   • Destination GMP certificate required
   • EU-GMP Part I for EU market exports
4. GMP Pathway Cleared ✓
   GMP requirements satisfied. Proceed to import license application.