GMP Pathway

Workflow steps

1. GMP Assessment
   Croatia is an EEA country. HALMED issues EU-GMP certificates and accepts EEA + PIC/S certificates. EU-GMP Part I required for all finished medicinal cannabis.
2. EU-GMP Part I Required
   All finished medicinal cannabis must be manufactured under EU-GMP Part I. Certificate from any EEA competent authority is accepted by HALMED.
   • EEA authority EU-GMP Part I certificate
   • Cannabis manufacturing scope explicitly stated
   • Certificate must be current (valid at time of import)
3. HALMED Accepts EEA + PIC/S
   HALMED accepts all EEA-issued GMP certificates. PIC/S member certificates also accepted. HALMED itself issues EU-GMP certificates for Croatian manufacturers.
   • EEA or PIC/S member GMP certificate
   • Cannabis manufacturing scope stated
   • HALMED evaluates on case-by-case basis
4. QP Release
   EU QP certifies batch for Croatian market release.
   • QP named on Croatian wholesale authorization
   • Full batch record reviewed
5. GMP Pathway Cleared ✓
   GMP requirements satisfied. Proceed with HALMED import authorization application.