Poland is an EU member. EU-GMP Part I required for all finished medicinal cannabis. URPL participates in EU GMP network. Poland has no significant domestic cannabis manufacturing — all product is imported.
EU-GMP Part I Required
Mandatory for all finished medicinal cannabis. Certificate from EEA authority or PIC/S body required.
EEA or PIC/S certificate with cannabis scope
QP at Polish importer certifies batches
Polish Language Documentation
URPL requires Polish-language elements in the import authorization application. Summary of product characteristics in Polish required.
Polish-language SmPC summary
URPL may require certified Polish translations
English COA and GMP certificates accepted but Polish labeling required for product
Polish QP Batch Release
QP certifies each batch for Polish market. Polish language not required for batch certificate.
QP named on Polish wholesale authorization
Full batch record reviewed
Released for Polish Supply ✓
QP-certified batch distributed to Polish pharmacies.