Pharmacy and Poisons Board
PPB · Kenya · africa
Kenya's Pharmacy and Poisons Board — 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.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Kenya
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
Relevant Regulation Codes
- Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya
- Kenyan framework for traditional and alternative medicine practice as appropriate
Prescriber Requirements
- Kenya Medical Practitioners and Dentists Council–registered physician — order required for any biomedical device application
- Traditional health practitioners registered under Kenyan national law may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
PPB registration as applicable; English and Kiswahili-language labelling. Standard cold-chain conditions.
Import/Export Rules
PPB import authorisation; Directorate of Veterinary Services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Kenya is moving toward an enhanced medical-device regulatory framework; whether hirudotherapy is being captured by these reforms 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.