Federal Service for Surveillance in Healthcare — Roszdravnadzor
Roszdravnadzor · Russia · europe
Russia's federal healthcare regulator — uniquely classifies medicinal leeches as a pharmaceutical drug under Federal Law No. 61-FZ, with a federally recognised hirudotherapy speciality and OMS coverage.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Russia
- Leech status
- drug classified
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Federal Law No. 61-FZ — On Circulation of Medicines (2010)
- Federal Law No. 323-FZ — On Health Protection (2011)
- Ministry of Health Order No. 142n (training standards for hirudotherapy)
- Pharmacopoeia of the Russian Federation, XIV ed., monograph Hirudo medicinalis
Prescriber Requirements
- Vrach (physician) with hirudotherapist sub-specialty certification — Russia is one of the few countries where hirudotherapy is a federally recognised medical specialty
- Training requirements: documented postgraduate course (typically ≥ 144 hours) at an institution licensed by the Ministry of Health
- Allied staff (medsestra / nurse) may apply under physician supervision
Supply Chain & GMP
Manufacturers must hold GMP-equivalent licence under No. 61-FZ; aptechnaya organizatsiya (pharmacy organisation) dispenses. Russian Pharmacopoeia XIV monograph defines storage, water specifications, and identity testing.
Import/Export Rules
Import licence from Roszdravnadzor; biological product status under Federal Law No. 61-FZ; CITES paperwork for Hirudo medicinalis / verbana. Domestic leech-farms (notably Mednapsa, Saint-Petersburg, and Internatsionalnaya Meditsina Group) supply most internal demand.
Reimbursement Context
OMS (Obyazatel'noe Meditsinskoe Strakhovanie / compulsory medical insurance) covers hirudotherapy in approved indications via outpatient policlinic departments and sanatoriy networks. Russia has the world's most extensive insurance-funded outpatient hirudotherapy.
Key Regulatory Documents
ASH Editorial Notes
Russia is the global outlier in regulating leeches as a pharmaceutical drug rather than a medical device — a holdover from the Soviet pharmacopoeial tradition. The Russian Academy of Medical Sciences (RAMS) houses dedicated hirudotherapy research centres; postgraduate medical education recognised since 1990s.
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.