Agencija za lijekove i medicinske proizvode — Croatian Agency for Medicinal Products and Medical Devices
HALMED · Croatia · europe
Croatia's agency for medicinal products and medical devices — applies EU MDR; leech-specific regulation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Croatia
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.halmed.hr
Relevant Regulation Codes
- Zakon o medicinskim proizvodima (Croatian Medical Devices Act)
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- Croatian-licensed liječnik (physician) prescription required
- Scope of non-physician practitioners for hirudotherapy not independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration with HALMED; Croatian-language IFU; cold chain per manufacturer specifications.
Import/Export Rules
Intra-EU free movement. Third-country imports through HALMED notification, Ministarstvo poljoprivrede for live-invertebrate clearance, and standard CITES Appendix II paperwork.
Reimbursement Context
HZZO (Croatian Health Insurance Fund) covers inpatient indications via hospital funding; specific outpatient hirudotherapy reimbursement not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Croatia joined the EU in 2013 and has implemented MDR through national legislation. Specific leech regulatory practice has not been independently verified by ASH; entry reflects expected EU MDR framework alignment.
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.