GMP Pathway

Workflow steps

1. GMP Assessment
   Belgium is EEA. FAMHP is a major EU-GMP issuing authority — Belgium is one of Europe's largest pharma manufacturing hubs. EU-GMP Part I is mandatory for all finished medicinal cannabis imports.
2. EU-GMP Part I Required — Mandatory for finished product
   All finished cannabis imported into Belgium must be manufactured under EU-GMP Part I. Certificate must be issued by an EEA competent authority or PIC/S-recognised body.
   • EEA authority or PIC/S recognised certificate
   • Cannabis manufacturing scope explicitly stated
   • QP at Belgian importer certifies each batch
3. FAMHP GMP Inspection / Certification
   FAMHP issues EU-GMP certificates to EEA-based manufacturers. For imports, FAMHP accepts all EEA-issued EU-GMP certificates and PIC/S member certificates directly.
   • Any EEA national authority EU-GMP Part I certificate accepted
   • PIC/S member certificates accepted (MHRA, TGA, Health Canada, IMFA)
   • Certificate scope must cover cannabis manufacturing
4. QP Batch Release
   All batches released to the Belgian market must be certified by an EU Qualified Person named on the Belgian importer's wholesale authorization.
   • QP named on Belgian wholesale authorization
   • Full batch record and COA reviewed
   • QP signature on batch certificate required
   • Legally liable for each released batch
5. Released for Belgian Supply ✓
   QP-certified batch available for distribution to Belgian pharmacies or magistral preparation pharmacists.