Agencia Española de Medicamentos y Productos Sanitarios
AEMPS · Spain · europe
Spanish medicines and devices agency — leech therapy regulated as a medical device with mandatory Spanish-language IFU and autonomous-community-level integration in some public health services.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Spain
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.aemps.gob.es
Relevant Regulation Codes
- Real Decreto 192/2023 — productos sanitarios (national MDR implementation)
- Ley 29/2006 — garantías y uso racional de los medicamentos
- Reglamento (UE) 2017/745 (MDR)
Prescriber Requirements
- Médico colegiado prescription required
- Enfermero/a (RN) application under physician's order; podólogos and fisioterapeutas have restricted scope
- Práctica complementaria not federally licensed; some autonomous communities register practitioners
Supply Chain & GMP
AEMPS communication required for distributors; Spanish-language labelling mandatory under Real Decreto 192/2023. Cold-chain 4–10 °C.
Import/Export Rules
Intra-EU free movement. Third-country imports via Agencia Tributaria — Aduanas, plus SOIVRE veterinary clearance for live invertebrates. CITES paperwork via Ministerio para la Transición Ecológica.
Reimbursement Context
SNS (Sistema Nacional de Salud) covers inpatient reconstructive indications; autonomous communities (Cataluña, Andalucía, País Vasco) may extend coverage to selected outpatient indications under their own carteras de servicios.
Key Regulatory Documents
ASH Editorial Notes
Spain's medicinal leech ecosystem is concentrated in dermatology and reconstructive surgery; Universidad Complutense de Madrid hosts academic-clinical research on Hirudo medicinalis applications.
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.