Product Approval

Workflow steps

1. Product Submission
   DKMA maintains an approved list of cannabis products that may be imported. Products not on the list require named patient authorization.
2. Prepare Product Dossier
   Product specifications, analytical methods, stability data, GMP/GACP certificates submitted to DKMA for product approval.
   • Product name, form, THC/CBD content
   • Manufacturing site GMP certificate
   • GACP certificate
   • COA and analytical specifications
   • Stability data summary
3. DKMA Product Evaluation
   DKMA evaluates product dossier. Processing: approximately 4–8 weeks for complete applications.
4. Product approved?
   DKMA approves or requests additional information.
5. Product on DKMA Approved List ✓
   Product may now be imported via per-shipment DKMA import license. Prescribers may prescribe to patients.