Direction de la Pharmacie et du Médicament — Tunisie
DPM Tunisia · Tunisia · africa
Tunisia's Directorate of Pharmacy and Medicines (Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework or traditional-medicine pathways as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Tunisia
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- http://www.dpm.tn
Relevant Regulation Codes
- Tunisian Code de la Santé Publique — pharmaceutical and device provisions
- Tunisian national medical device regulatory framework
Prescriber Requirements
- Conseil National de l'Ordre des Médecins de Tunisie–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Ministry of Health registration as applicable; Arabic and French-language labelling. Standard cold-chain conditions, with logistical considerations typical of North African distribution.
Import/Export Rules
DPM and Ministry of Health import authorisation; 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. North African regulators frequently follow French (ANSM) regulatory conventions for pharmaceutical and device terminology; whether this extends to live-organism medical devices has not been independently mapped by ASH.
Related Jurisdictions
ANSM — France
Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.
EDA — Egypt
Egypt's Egyptian Drug Authority (formed 2019, replacing the older CAPA / Central Administration of Pharmaceutical Affairs) — leech therapy regulated as a medical device with parallel traditional-medicine context.
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.