SAHPRA

The South African Health Products Regulatory Authority (SAHPRA) is the statutory regulator of medicines, medical devices, in-vitro diagnostics, clinical trials, complementary medicines, and cosmetics in South Africa. It was established in 2018 as the successor to the Medicines Control Council (MCC), with broadened scope and an explicit mandate to reduce historical backlogs.

**Functions relevant to cannabis prescribing:** - Issuing **Section 21 authorisations** for unregistered medicines, including the overwhelming majority of medical-cannabis products in current SA practice. - Reviewing **product registrations** for cannabis-based medicines that pursue routine registration (a slow process — most cannabis products remain Section 21). - Setting **scheduling** of cannabinoids (Schedule 0 for low-dose CBD under Gazette 43347, Schedule 4/6 for therapeutic doses). - Inspecting **licensed pharmacy** dispensing of Section 21 medicines.

**What SAHPRA does not do** — it does not prescribe, does not provide clinical advice to patients, and does not influence the doctor's clinical judgement. A SAHPRA approval authorises access to the product; whether that product is right for an individual patient is the prescribing doctor's decision.

**Turnaround** — typical Section 21 review is 2–3 business days for complete applications. Where SAHPRA requests additional information, the doctor responds and the clock effectively pauses. Outright declines are uncommon for well-prepared applications and are rarely permanent.