Agência Reguladora dos Sectores Farmacêutico e Alimentar — Cabo Verde
Cape Verde ARFA · Cape Verde · africa
Cape Verde's pharmaceutical / food regulatory agency — leech-specific authorisation pathway not independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Cape Verde
- Leech status
- unregulated
- Last ASH review
- 2026-05-28
- Website
- https://www.arfa.cv
Relevant Regulation Codes
- Cape Verde Lei do Medicamento (Medicines Law) and amendments
- ECOWAS Pharmaceutical Regulatory Harmonisation arrangements where applicable
Prescriber Requirements
- Cape Verde Ordem dos Médicos–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Cape Verde ARFA registration as applicable; Portuguese-language labelling. Standard cold-chain conditions, with logistical constraints typical of West-African archipelago distribution.
Import/Export Rules
Cape Verde ARFA and Direcção-Geral da Agricultura, Silvicultura e Pecuária clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Cape Verde's social-security health 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.
Infarmed — Portugal
Portugal's national medicines and health products authority — applies EU MDR for medical devices; leech-specific regulation has not been independently verified by ASH.
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.