GMP Pathway

Workflow steps

1. GMP Assessment
   Denmark is an EU member. EU-GMP Part I required for all finished medicinal cannabis imports. DKMA participates in EU GMP inspection network.
2. EU-GMP Part I Required — Mandatory for finished product
   All finished cannabis imported into Denmark must be manufactured under EU-GMP Part I. Certificate from EEA or PIC/S authority required.
   • EEA or PIC/S certificate with cannabis scope
   • QP at Danish importer certifies batches
3. DKMA Product Approval
   Manufacturing site GMP certificate must be current when product approval application is submitted to DKMA.
   • Current EU-GMP Part I certificate included in product approval dossier
   • GACP certificate also required
4. Danish QP Batch Release
   QP named on Danish importer's wholesale authorization certifies each batch.
   • QP named on Danish wholesale authorization
   • Full batch record reviewed
   • Danish-language batch certificate not required — English accepted
5. Released for Danish Supply ✓
   QP-certified batch available for Danish pharmacy distribution.