Federal Agency for Medicines and Health Products
FAMHP · Belgium · europe
Belgium's federal agency for medicines and health products — applies EU MDR for devices; leech-specific regulation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Belgium
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.fagg-afmps.be
Relevant Regulation Codes
- Loi du 15 juin 2022 relative aux dispositifs médicaux (Belgian Medical Devices Act)
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- Belgian-licensed médecin / arts prescription required
- Scope of non-conventional practitioners under the Loi Colla (1999) and subsequent royal decrees for hirudotherapy not independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration with FAMHP; trilingual French / Dutch / German labelling per Belgian language law; cold chain per manufacturer specifications.
Import/Export Rules
Intra-EU free movement. Third-country imports through FAMHP notification, FAVV / AFSCA for live-invertebrate clearance, and standard CITES Appendix II paperwork.
Reimbursement Context
INAMI / RIZIV covers inpatient indications via the Belgian nomenclature; specific hirudotherapy reimbursement status not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Belgium recognises four non-conventional medicine modalities under the Loi Colla (acupuncture, chiropractic, homeopathy, osteopathy); hirudotherapy is not on the recognised list. Specific regulatory practice has not been independently verified by ASH.
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.