Agjencia e Kosovës për Produkte dhe Pajisje Mjekësore
AKPPM · Kosovo · europe
Kosovo's Medicines Agency — 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
- Kosovo
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://akppm.rks-gov.net
Relevant Regulation Codes
- Kosovo Law No. 04/L-190 on Medical Devices
- Kosovo Law No. 02/L-128 on Medicinal Products and Medical Devices, as amended
Prescriber Requirements
- Kosovo Chamber of Doctors–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
AKPPM registration as applicable; Albanian and Serbian-language labelling. Standard cold-chain conditions.
Import/Export Rules
AKPPM and Kosovo Food and Veterinary Agency clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Kosovo's basic health package 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 medical device / traditional medicine framework as appropriate. Kosovo's regulatory framework is progressively converging toward the EU acquis; international recognition of Kosovo's statehood and regulatory acts varies; whether this captures live-organism medical devices 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.