Agenzia Italiana del Farmaco
AIFA · Italy · europe
Italian Medicines Agency — leech therapy supervised under MDR via the Ministero della Salute, with established complementary-medicine reimbursement in selected regions (Toscana, Emilia-Romagna).
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Italy
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.aifa.gov.it
Relevant Regulation Codes
- D.Lgs. 219/2006 — Codice dei medicinali
- Regolamento (UE) 2017/745 (MDR)
- D.M. 15 luglio 1997 (good clinical practice)
Prescriber Requirements
- Medico chirurgo (MD) prescription required
- Application by infermiere under physician's order; specialised training by Società Italiana di Idrologia Medica e Climatologia (SIIMC)
- Regional registers of agopuntori (acupuncturists) include hirudotherapy in some regions (e.g., Toscana)
Supply Chain & GMP
Ministero della Salute database registration; Italian-language labelling per D.Lgs. 46/97. Cold-chain 4–10 °C; pharmacy (farmacia ospedaliera) dispenses in hospital setting.
Import/Export Rules
Intra-EU free movement. Third-country imports through Agenzia delle Dogane plus Ministero della Salute SISMG portal. CITES via CITES Italian Management Authority (CFS — Carabinieri Forestali).
Reimbursement Context
SSN (Servizio Sanitario Nazionale) covers inpatient indications via DRG bundling. Some regions reimburse complementary medicine including hirudotherapy (Toscana, Lombardia in pilot); private insurance varies.
Key Regulatory Documents
ASH Editorial Notes
Italian dermatology and physical-medicine specialties have a long tradition of hirudotherapy; AIFA has not issued device-specific guidance because leeches are MDR-classified rather than AIFA-classified medicinal products.
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.