Agencia Estatal de Medicamentos y Tecnologías en Salud — Bolivia
AGEMED · Bolivia · latin america
Bolivia's Agencia Estatal de Medicamentos y Tecnologías en Salud (Ministerio de Salud y Deportes) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under Andean traditional medicine alongside the contemporary biomedical framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- latin america
- Country
- Bolivia
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.minsalud.gob.bo
Relevant Regulation Codes
- Bolivian Ley del Medicamento (Ley 1737)
- Bolivian Ley de Medicina Tradicional Ancestral Boliviana (Ley 459)
- Bolivian national medical device regulatory framework
Prescriber Requirements
- Bolivian Colegio Médico–registered physician — order required for any biomedical device application
- Traditional ancestral medicine practitioners credentialed under Ley 459 may have separate scope; specific contemporary hirudotherapy authorisation has not been independently verified by ASH
Supply Chain & GMP
AGEMED registration as applicable; Spanish-language labelling required by national law (with Quechua and Aymara supplementary information as relevant under Ley 459). Standard cold-chain conditions, with logistical constraints typical of high-altitude Andean distribution.
Import/Export Rules
AGEMED and Servicio Nacional de Sanidad Agropecuaria e Inocuidad Alimentaria (SENASAG) clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Sistema Único de Salud (SUS) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Bolivia has formal statutory recognition of ancestral traditional medicine through Ley 459 (2013), and the interface between this framework and the contemporary biomedical pathway for any specific therapeutic modality, including hirudotherapy, has not been independently mapped by ASH.
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.
ANMAT — Argentina
Argentina's national administration of drugs, food and medical technology — leech-specific regulatory pathway has not been independently verified by ASH.