Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
ANMAT · Argentina · latin america
Argentina's national administration of drugs, food and medical technology — leech-specific regulatory pathway has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Argentina
- Leech status
- unregulated
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Ley 16.463 (Argentine medicines law)
- ANMAT medical device regulatory framework (Disposiciones)
Prescriber Requirements
- Argentine medical college-registered MD prescription required
- Non-physician practitioner scope for hirudotherapy not independently verified by ASH
Supply Chain & GMP
ANMAT product registration if classified as a medical device; Spanish-language labelling.
Import/Export Rules
ANMAT import authorisation plus SENASA (Servicio Nacional de Sanidad y Calidad Agroalimentaria) veterinary clearance for live invertebrates; CITES Appendix II paperwork.
Reimbursement Context
PAMI, obras sociales, and prepagas (private prepaid health plans) coverage for hirudotherapy not independently verified by ASH.
ASH Editorial Notes
ANMAT operates under the Ministry of Health; specific regulatory pathway for medicinal leech use in Argentina has not been independently verified by ASH and should be confirmed with Argentine counsel.
Related Jurisdictions
ANVISA — Brazil
Brazil's national health-surveillance agency — leech therapy regulated as a medical device with parallel coverage under the SUS Practices Integrativas e Complementares (PICS) policy.
INVIMA — Colombia
Colombia's national medicines and devices surveillance agency — leech therapy regulated as a medical device under Decreto 4725/2005 with TM/CAM oversight by the Ministerio de Salud.
DIGEMID — Peru
Peru's medicines, supplies and drugs directorate — leech therapy supervised under Ley General de Salud and complementary-medicine framework, with DIRESA-level enforcement.
ISP — Chile
Chile's Public Health Institute — national reference authority for medicines and medical devices; leech-specific regulatory pathway has not been independently verified by ASH.