Agenția Medicamentului și Dispozitivelor Medicale — Agency of Medicines and Medical Devices of the Republic of Moldova
AMDM · Moldova · europe
Moldova's Agency of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have a documented role in the continuous Russian-Romanian regional hirudotherapy tradition, with contemporary status under the Moldovan biomedical framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Moldova
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://amdm.gov.md
Relevant Regulation Codes
- Moldovan Law on Medicinal Products (Legea cu privire la activitatea farmaceutică)
- Moldovan national medical device regulatory framework (progressively aligning with EU MDR 2017/745 as part of EU accession process)
- Moldovan Ministry of Health and Social Protection orders on traditional and folk medicine where applicable
Prescriber Requirements
- Moldovan College of Physicians–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
AMDM registration as applicable; Romanian-language labelling required by national law (with Russian-language supplementary information where relevant). Standard cold-chain conditions.
Import/Export Rules
AMDM and National Food Safety Agency clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
National Health Insurance Company (Compania Națională de Asigurări în Medicină) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Moldova sits at the regulatory and clinical interface of the Romanian (EU) and Russian-Soviet hirudotherapy traditions. 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.