GMP Pathway

Workflow steps

1. GMP Assessment
   Ireland is EEA (not EU but in single market). HPRA is one of the world's most significant EU-GMP issuing authorities — Ireland hosts the world's largest pharma manufacturing base. 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 Ireland 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 Irish importer certifies each batch
3. HPRA GMP Certification
   HPRA issues EU-GMP certificates to EEA-based manufacturers. For imports, HPRA 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 Irish market must be certified by an EU Qualified Person named on the Irish importer's wholesale authorization.
   • QP named on Irish wholesale authorization
   • Full batch record and COA reviewed
   • QP signature on batch certificate required
   • Legally liable for each released batch
5. Released for Irish Supply ✓
   QP-certified batch available for distribution to Irish pharmacies via licensed wholesaler.