Medicines Regulatory Council — Kingdom of Eswatini
Eswatini MRC · Eswatini · africa
Eswatini's MRC — leech-specific authorisation pathway not independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Eswatini
- Leech status
- unregulated
- Last ASH review
- 2026-05-28
- Website
- https://www.gov.sz
Relevant Regulation Codes
- Eswatini Medicines and Related Substances Act and amendments
- SADC regional regulatory cooperation arrangements where applicable
Prescriber Requirements
- Eswatini Medical and Dental Council–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Eswatini MRC registration as applicable; English and siSwati-language labelling. Standard cold-chain conditions, with logistical constraints typical of Southern-African distribution.
Import/Export Rules
Eswatini MRC and Department of Veterinary Services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Eswatini's public health system 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.
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.