Scientific Centre of Drug and Medical Technology Expertise — Republic of Armenia
Armenia SCDMTE · Armenia · europe
Armenia's Scientific Centre of Drug and Medical Technology Expertise (Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Armenia
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.pharm.am
Relevant Regulation Codes
- Armenian Law on Medicines (Հայաստանի Հանրապետության դեղերի մասին օրենք)
- Armenian national medical device regulatory framework
- Eurasian Economic Union (EAEU) harmonised pharmaceutical and medical device frameworks
Prescriber Requirements
- Armenian Ministry of Health–licensed physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Armenia SCDMTE registration as applicable; Armenian-language labelling required by national law (with Russian-language supplementary information where relevant). Standard cold-chain conditions; EAEU customs procedures apply for cross-border movement.
Import/Export Rules
Ministry of Health and Food Safety Inspection Body clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana. EAEU customs procedures apply.
Reimbursement Context
State Health Agency coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Armenia is part of the Eurasian Economic Union, sharing elements of pharmaceutical regulatory harmonisation with Russia, Belarus, and Kazakhstan. The contemporary statutory pathway for hirudotherapy has not been independently mapped 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.