Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
URPL · Poland · europe
Poland's Office for Registration of Medicinal Products, Medical Devices and Biocidal Products — applies EU MDR; leech-specific regulation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Poland
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.urpl.gov.pl
Relevant Regulation Codes
- Ustawa o wyrobach medycznych (Polish Medical Devices Act, 2022)
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- Naczelna Izba Lekarska-registered MD prescription required
- Non-physician practitioner scope for hirudotherapy not independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration with URPL; Polish-language IFU; cold chain per manufacturer specifications.
Import/Export Rules
Intra-EU free movement. Third-country imports through URPL notification and standard CITES Appendix II paperwork; Główny Inspektorat Weterynarii for live-invertebrate clearance.
Reimbursement Context
NFZ (Narodowy Fundusz Zdrowia) covers inpatient indications via hospital DRG bundling; specific outpatient hirudotherapy reimbursement status not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Poland has a substantial traditional and complementary medicine community; specific regulatory framework applicable to hirudotherapy has not been independently verified by ASH and should be reviewed by Polish counsel before relying on for compliance.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.