Czech market access via SÚKL marketing authorization or magistral preparation (compounding) pathway. Most cannabis in Czech Republic is dispensed as magistral preparations.
MA or Magistral?
Full SÚKL MA provides commercial scale. Magistral preparation pathway allows pharmacies to compound cannabis preparations from imported cannabis drug substance.
Full SÚKL MA Pathway
Full marketing authorization via SÚKL or EMA/mutual recognition. Requires full CTD dossier.
Complete CTD dossier
Czech-language Module 1
SÚKL evaluation fee
12–18 month review
Magistral Preparation Pathway — Most common
Cannabis drug substance (dried flower or extract) imported and dispensed as magistral preparation by Czech pharmacies. Simpler market entry.
Cannabis drug substance import authorization from SÚKL
Pharmacy prepares magistral preparation per prescription
Czech Pharmacopoeia standards apply
MA Granted ✓
Commercial supply at scale.
Magistral Supply Active ✓
Cannabis drug substance imported and dispensed via pharmacy compounding. No SÚKL MA required for the drug substance itself.