Direction de la Pharmacie et du Médicament — République du Mali
Mali DPM · Mali · africa
Mali's pharmacy / medicine directorate — leech-specific authorisation pathway not independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Mali
- Leech status
- unregulated
- Last ASH review
- 2026-05-28
- Website
- https://sante.gouv.ml
Relevant Regulation Codes
- Mali Code de Santé Publique and amendments
- ECOWAS Pharmaceutical Regulatory Harmonisation arrangements where applicable
Prescriber Requirements
- Mali Ordre des Médecins–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Mali DPM registration as applicable; French-language labelling. Standard cold-chain conditions with logistical constraints typical of Sahel distribution.
Import/Export Rules
Mali DPM and Direction Nationale des Services Vétérinaires clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Mali AMO (Assurance Maladie Obligatoire) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific authorisation pathway not independently verified by ASH; falls under general medical-device / traditional-medicine framework as appropriate. ECOWAS West-African regulatory harmonisation arrangements have not been independently mapped by ASH for live-organism medical devices.
Related Jurisdictions
SAHPRA — South Africa
South Africa's SAHPRA (created 2018, replacing the Medicines Control Council) — leech therapy regulated as a medical device under the Medicines and Related Substances Act; traditional-health practitioners under separate THP Council.
NAFDAC — Nigeria
Nigeria's national agency for food and drug administration and control — leech-specific regulatory pathway has not been independently verified by ASH.
DMP Morocco — Morocco
Morocco's Directorate of Medicines and Pharmacy under the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH.
FDA Ghana — Ghana
Ghana's Food and Drugs Authority — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework or traditional medicine pathways as appropriate.