Bundesinstitut für Arzneimittel und Medizinprodukte
BfArM · Germany · europe
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Germany
- Leech status
- drug classified
- Last ASH review
- 2026-05-25
- Website
- https://www.bfarm.de
Relevant Regulation Codes
- Arzneimittelgesetz (AMG) — Medicines Act, § 21 (Marketing Authorisation)
- Apothekenbetriebsordnung (ApBetrO) — Pharmacy Operations Ordinance
- Heilpraktikergesetz (HeilprG) of 1939 (governs non-physician practice)
Prescriber Requirements
- Physician (Arzt) prescription strongly recommended; medicinal-product status means leeches are dispensed via Apotheke (pharmacy)
- Heilpraktiker (state-licensed non-physician healers) have legal scope to apply leeches under HeilprG
- Hirudotherapy training is offered by Deutscher Naturheilbund and Kneipp-Bund; not a federally credentialed specialty
Supply Chain & GMP
Marketing authorisation holder must operate to EU-GMP and § 13 AMG manufacturing licence. Pharmacies receive leeches in approved transport (PZN-tagged). Cold chain 4–10 °C; storage water specifications in product monograph.
Import/Export Rules
Intra-EU free movement once AMG-approved. Import from third countries requires § 72 AMG import licence and PEI (Paul-Ehrlich-Institut) consultation. CITES paperwork as elsewhere.
Reimbursement Context
GKV (Gesetzliche Krankenversicherung / statutory health insurance) covers leech therapy for arthrosis indications under § 137c SGB V (selected G-BA-approved diagnoses) and inpatient flap salvage. PKV (private) commonly reimburses by GOÄ digit 250–252 / 268.
Key Regulatory Documents
ASH Editorial Notes
Germany is the only major EU jurisdiction that treats leeches as a finished medicinal product rather than a medical device. BIEBERTAL (Biebertaler Blutegelzucht GmbH) is the principal German producer; second to Biopharm in European supply.
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).
ANSM — France
Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.