Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore — Republika e Shqipërisë
AKBPM · Albania · europe
Albania's National Agency of Medicines and Medical Devices — 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
- Albania
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://akbpm.gov.al
Relevant Regulation Codes
- Albanian Law No. 105/2014 on Medicinal Products and Pharmaceutical Service, as amended
- Albanian national medical device regulatory framework (progressively aligning with EU MDR 2017/745 in connection with EU accession negotiations)
Prescriber Requirements
- Albanian Order of Physicians–registered doctor — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
AKBPM registration as applicable; Albanian-language labelling. Standard cold-chain conditions.
Import/Export Rules
AKBPM and Ministry of Agriculture and Rural Development clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Albanian Mandatory Healthcare Insurance Fund (FSDKSh) 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. Albanian regulation is progressively converging toward the EU acquis as part of the EU accession process; 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.