Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România — National Agency of Medicines and Medical Devices
ANMDMR · Romania · europe
Romania'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 EU MDR framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Romania
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.anm.ro
Relevant Regulation Codes
- Romanian national implementing legislation for Regulation (EU) 2017/745 (MDR)
- Romanian Medicines Law (Legea medicamentului)
Prescriber Requirements
- Romanian-licensed physician (medic) registered with the Romanian College of Physicians — order required for any device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Distributors operate under EU MDR Article 14 economic-operator obligations; standard cold-chain conditions for live invertebrates. Romanian-language IFU.
Import/Export Rules
Intra-EU free circulation as per Regulation (EU) 2017/745. Third-country imports require CITES Appendix II paperwork for Hirudo medicinalis / verbana.
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. ANMDMR is the consolidated authority for both medicines and medical devices in Romania, harmonised with EU MDR.
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.