Lyfjastofnun — Icelandic Medicines Agency
IMA · Iceland · europe
Iceland's Medicines Agency — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the EEA-aligned medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Iceland
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.lyfjastofnun.is
Relevant Regulation Codes
- Icelandic national implementing legislation for Regulation (EU) 2017/745 (MDR) via the EEA Agreement
- Icelandic Medicines Act
Prescriber Requirements
- Icelandic-licensed physician (læknir) registered with the Directorate of Health — order required for any device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Distributors operate under EEA-aligned MDR economic-operator obligations; standard cold-chain conditions for live invertebrates. Icelandic-language IFU.
Import/Export Rules
EEA free movement applies; third-country imports require CITES Appendix II paperwork for Hirudo medicinalis / verbana and Icelandic Food and Veterinary Authority (MAST) clearance for live invertebrates.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Iceland participates in EU medicines and devices law via the EEA Agreement rather than EU membership.
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.