Agencija za lekove i medicinska sredstva Srbije — Medicines and Medical Devices Agency of Serbia
ALIMS · Serbia · europe
Serbia's Medicines and Medical Devices 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
- Serbia
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.alims.gov.rs
Relevant Regulation Codes
- Serbian Law on Medicines and Medical Devices (Official Gazette of the Republic of Serbia No. 30/2010, as amended)
- Serbian national medical device regulatory framework — progressively aligned with EU MDR 2017/745
Prescriber Requirements
- Serbian Medical Chamber–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
ALIMS registration as applicable; Serbian-language labelling. Standard cold-chain conditions; alignment with EU MDR is progressively advancing under EU accession negotiations.
Import/Export Rules
ALIMS and Ministry of Health import authorisation; veterinary services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Republic Fund for Health Insurance (RFZO) 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. As an EU candidate country, Serbia is progressively aligning with EU MDR; whether this includes specific guidance on 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.