Botswana Medicines Regulatory Authority
BoMRA · Botswana · africa
Botswana Medicines Regulatory Authority — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Botswana
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://www.bomra.co.bw
Relevant Regulation Codes
- Botswana Medicines and Related Substances Act, 2013
- Botswana national medical device regulatory framework
- Southern African Development Community (SADC) harmonised pharmaceutical frameworks where applicable
- African Medicines Agency (AMA) harmonised frameworks (where applicable)
Prescriber Requirements
- Botswana Health Professions Council–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
BoMRA registration as applicable; English-language labelling. Standard cold-chain conditions, with logistical constraints typical of landlocked Southern African distribution.
Import/Export Rules
BoMRA and Department of Veterinary Services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Botswana's public health system coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Southern African regulatory frameworks are progressively coordinating through SADC and the African Medicines Agency (AMA); whether this captures live-organism medical devices has not been independently mapped by ASH.
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.