Article 83 Compassionate Use – South Africa (SAHPRA)
SAHPRA Section 21 Application FormStatutory30 days
Description & Eligibility
Section 21 authorization allows for the sale of unregistered medicines in South Africa for compassionate use in individual patients or clinical trials. SAHPRA evaluates applications based on medical necessity and patient safety considerations.
Eligibility Criteria
Patients with life-threatening or seriously debilitating conditions where no registered alternative exists in South Africa
Legal Reference / Source
Medicines and Related Substances Act 101 of 1965, Section 21
Article 83 Compassionate Use – South Africa (SAHPRA)
| Approval Form | SAHPRA Section 21 Application Form |
| Timeline | 30 days |
| Legal Status | Statutory |
| Source Ref. | Medicines and Related Substances Act 101 of 1965, Section 21 |
| Countries | 0 countries |
Compliance Check
Legal Review3/21/2026
Global ValidityVerified