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Glossary

SAHPRA

The South African Health Products Regulatory Authority — the regulator of medicines and medical devices.

SAHPRA is the statutory regulator of medicines, medical devices, in-vitro diagnostics, clinical trials, and complementary medicines in South Africa. It issues Section 21 authorisations for unregistered medicines, including the majority of medical cannabis products. SAHPRA does not prescribe — that is the doctor’s clinical role — but reviews each Section 21 application and approves, declines, or requests more information. Typical turnaround is 2–3 business days for a complete application.

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