Compassionate Use Programme – South Africa
Section 21 Application FormRegulatory21 days
Description & Eligibility
SAHPRA mechanism for accessing unregistered medicines for patients with serious or life-threatening conditions. Requires detailed motivation from treating physician.
Eligibility Criteria
Patients with serious conditions where registered medicines are inadequate
Legal Reference / Source
Medicines and Related Substances Act 101 of 1965, Section 21
Compassionate Use Programme – South Africa
| Approval Form | Section 21 Application Form |
| Timeline | 21 days |
| Legal Status | Regulatory |
| Source Ref. | Medicines and Related Substances Act 101 of 1965, Section 21 |
| Countries | 0 countries |
Compliance Check
Legal Review3/21/2026
Global ValidityVerified