Изпълнителна агенция по лекарствата — Bulgarian Drug Agency
BDA · Bulgaria · europe
Bulgaria's Bulgarian Drug Agency — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Bulgarian national law; leech-specific national authorisation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Bulgaria
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.bda.bg
Relevant Regulation Codes
- Bulgarian Medicinal Products in Human Medicine Act (Закон за лекарствените продукти в хуманната медицина)
- EU Medical Device Regulation (MDR) 2017/745 — as transposed into Bulgarian law
- Bulgarian Medical Devices Act (Закон за медицинските изделия)
Prescriber Requirements
- Bulgarian Medical Association (Български лекарски съюз)–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
BDA registration as applicable; Bulgarian-language (Cyrillic script) labelling required by national law. Standard cold-chain conditions; EU intra-community movement under MDR applies.
Import/Export Rules
Free movement within the EU single market under MDR; Bulgarian Food Safety Agency clearance for live invertebrates from non-EU origin; CITES Appendix II paperwork for Hirudo medicinalis / verbana on extra-EU import.
Reimbursement Context
National Health Insurance Fund (НЗОК) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general EU MDR framework as transposed into Bulgarian law. BDA coordinates with EMA and other EU NCAs; whether leech-specific guidance exists 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.