State Expert Center of the Ministry of Health of Ukraine
Ukraine SEC · Ukraine · europe
Ukraine's State Expert Center of the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have a documented clinical role in the continuous Russian-Ukrainian hirudotherapy tradition, with contemporary status under the Ukrainian biomedical framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Ukraine
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.dec.gov.ua
Relevant Regulation Codes
- Ukrainian Law on Medicinal Products (Закон України про лікарські засоби)
- Ukrainian framework for medical devices (progressively aligned with EU MDR 2017/745 as part of EU accession process)
- Ukrainian Ministry of Health regulations on traditional and folk medicine where applicable
Prescriber Requirements
- Ukrainian Medical Council–licensed physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
State Expert Center registration as applicable; Ukrainian-language labelling required by national law. Standard cold-chain conditions; logistical conditions affected by ongoing armed conflict since 2022.
Import/Export Rules
Ministry of Health and State Service of Ukraine for Food Safety and Consumer Protection clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana. Cross-border logistics are substantially affected by the armed conflict since 2022.
Reimbursement Context
National Health Service of Ukraine (NHSU) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Ukraine shares the broader continuous Russian-Soviet-post-Soviet hirudotherapy clinical tradition described under the Botkin / Baskova / Kurdyumov biographical entries. The contemporary statutory pathway for hirudotherapy within the Ukrainian biomedical framework has not been independently mapped by ASH. Regulatory operations are substantially affected by the armed conflict since 2022; this entry should be treated as preliminary and confirmed with Ukrainian regulatory counsel before any operational use.
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.