Polish market access via URPL marketing authorization. Most cannabis in Poland is imported as a registered medicine or via individual import authorization (IIA) for unregistered products.
MA or Individual Import Auth?
Full URPL MA provides commercial supply. Individual Import Authorization (IIA) per patient or prescriber batch is the practical pathway for most unregistered products.
Full URPL MA
Via EU mutual recognition or national procedure. Requires full CTD dossier. Most complex but provides broadest commercial access.
Full CTD dossier in Polish and English
EU mutual recognition or national URPL procedure
12–18 month timeline
Individual Import Authorization (IIA) — Most common pathway
Physician applies to URPL for IIA to import a specific unregistered cannabis product for a specific patient.
Physician submits IIA application to URPL
Medical justification required
Processing: 30–60 days
Each IIA valid for one patient and defined quantity
MA Granted ✓
Commercial supply at scale possible.
IIA Supply Active ✓
Supply for specific patient under IIA. Cumbersome but functional pathway for market entry.