Agencija za lijekove i medicinska sredstva Bosne i Hercegovine
ALMBIH · Bosnia and Herzegovina · europe
Bosnia and Herzegovina's Agency for Medicinal Products 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
- Bosnia and Herzegovina
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.almbih.gov.ba
Relevant Regulation Codes
- Bosnian Law on Medicinal Products and Medical Devices (Official Gazette of BiH No. 58/08)
- Bosnian national medical device regulatory framework (progressively aligning with EU MDR 2017/745)
Prescriber Requirements
- Medical chamber–registered doctor (entity-level) — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
ALMBIH registration as applicable; Bosnian / Croatian / Serbian-language labelling. Standard cold-chain conditions.
Import/Export Rules
ALMBIH and entity-level veterinary authorities clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Entity-level health insurance fund coverage (Federation of BiH / Republika Srpska / Brčko District) 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. Bosnia and Herzegovina's regulatory framework is split between state-level competencies and entity-level health insurance funds; 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.