GMP Pathway

Workflow steps

1. GMP Assessment
   Czech Republic is an EU member — EU-GMP Part I required for all finished medicinal cannabis. SÚKL participates fully in the EU GMP inspection network.
2. Finished product or API?
   Finished product requires EU-GMP Part I. API/bulk supply to a Czech finisher may use EU-GMP Part II.
3. EU-GMP Part I Required — All finished imports
   Mandatory for all finished medicinal cannabis distributed to Czech pharmacies. Certificate from any EEA authority or PIC/S-recognised body accepted.
   • EEA authority or PIC/S recognised certificate
   • Cannabis scope explicitly stated
   • QP at Czech importer certifies each batch
4. EU-GMP Part II — API to Czech finisher
   Accepted for bulk API supply to a Czech Pharmaceutical Act §63-licensed manufacturer.
   • Czech licensed manufacturer takes Part I responsibility
   • Czech QP releases finished batch
5. Czech QP Batch Release
   EU Qualified Person named on Czech importer's wholesale authorization certifies each batch.
   • QP named on SÚKL wholesale authorization
   • Full batch record reviewed
   • QP legally liable for each released batch
6. Released for Czech Supply ✓
   QP-certified batch available for distribution to Czech pharmacies.