Ministeri de Salut — Govern d'Andorra
Andorra MS · Andorra · europe
Andorra's Ministry of Health — 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, with practical reliance on Spanish AEMPS and French ANSM authorisations.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Andorra
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.salut.ad
Relevant Regulation Codes
- Andorran Llei general de sanitat (Llei 20/2014, qualificada, as amended)
- Operational reliance on Spanish AEMPS / French ANSM authorisations for medicinal products in practice
Prescriber Requirements
- Col·legi Oficial de Metges d'Andorra–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Catalan, Spanish or French-language labelling per local convention; standard cold-chain conditions. Products typically enter via Spanish or French customs and distribution channels.
Import/Export Rules
Andorra Departament d'Agricultura i Ramaderia clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Caixa Andorrana de Seguretat Social (CASS) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Andorra's small jurisdiction relies heavily on Spanish AEMPS and French ANSM authorisations in practice; whether the national legal framework would treat live-organism medical devices distinctly 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.