Compassionate Use / Access to Unregistered Medicines – South Africa
Unregistered medicines application / compassionate-use submissionStatutory/Administrative
Description & Eligibility
South Africa allows access to unregistered medicines through a controlled compassionate-use process overseen by the South African Health Products Regulatory Authority. Access is generally limited to serious or life-threatening conditions when no registered alternative is suitable and requires regulatory authorization. [?]
Eligibility Criteria
Patients with serious or life-threatening conditions for whom no registered therapeutic alternative exists or is appropriate.
Legal Reference / Source
Medicines and Related Substances Act and SAHPRA guidance on access to unregistered medicines
Compassionate Use / Access to Unregistered Medicines – South Africa
| Approval Form | Unregistered medicines application / compassionate-use submission |
| Legal Status | Statutory/Administrative |
| Source Ref. | Medicines and Related Substances Act and SAHPRA guidance on access to unregistered medicines |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified