European Medicines Agency
EMA · European Union · europe
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
Regulatory Profile
- Agency type
- supranational
- Region
- europe
- Country
- European Union
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://www.ema.europa.eu
Relevant Regulation Codes
- Regulation (EC) No 726/2004 — Community procedures for medicinal products
- Directive 2001/83/EC — Medicinal products for human use (Title III bis: Traditional Herbal Medicinal Products)
- Regulation (EU) 2017/745 — Medical Device Regulation (MDR) — where leeches are deployed as a device
Prescriber Requirements
- EMA itself does not license prescribers; national authorities of EU Member States set scope of practice
- Most Member States restrict to physicians; some recognise Heilpraktiker (Germany), naturopath, or osteopath scope
Supply Chain & GMP
Manufacturers placing leeches on the EU market under MDR must hold CE marking via Notified Body (Class IIa expected). EU Authorized Representative required for non-EU manufacturers. UDI under MDR Art. 27. Cold chain 4–10 °C; transport under Annex I GSPR.
Import/Export Rules
CITES Appendix II permit required for cross-border movement of Hirudo medicinalis / verbana; EU TRACES NT used for veterinary border controls; intra-EU movement under single-market rules with established traceability.
Reimbursement Context
EMA does not set reimbursement — national social-insurance bodies decide. Germany (SHI), France (AM), Italy (SSN), and Russia have explicit reimbursement schedules; most other EU countries restrict reimbursement to inpatient flap-salvage indications.
Key Regulatory Documents
ASH Editorial Notes
Leeches are NOT centrally authorised as a medicinal product. Member States individually classify them either as medical devices (most common, post-MDR) or traditional medicines (Germany, Italy in selected indications). UK has diverged post-Brexit (see mhra-uk).
Related Jurisdictions
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.
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.