Section 21

Section 21 of the **Medicines and Related Substances Act 101 of 1965** is the legal mechanism that allows the South African Health Products Regulatory Authority (SAHPRA) to authorise patient access to medicines that are not yet formally registered for general sale in South Africa.

**The application contains:** a confirmed diagnosis (with ICD-11 code), patient demographics, treatment history showing what conventional first-line and second-line therapies have been trialled with response and reasons for discontinuation, the specific product requested with proposed dose and duration, and the prescribing doctor's clinical rationale. Strong applications also reference relevant specialist correspondence.

**Validity** — each authorisation is patient-specific, product-specific, and time-limited (typically 6 months). A **Named Patient Application (NPA)** covers a single individual; a **Multiple Patient Application (MPA)** can cover a cohort with the same indication.

**Process** — applications are filed by an HPCSA-registered doctor, reviewed independently by SAHPRA (typical turnaround 2–3 business days), and result in approval, conditional approval (more information requested), or decline-with-reason. Common decline reasons include incomplete first-line trial documentation, missing specialist input where the indication usually requires it, or product mismatch with the indication. Declines are not permanent — resubmission with additional evidence is often appropriate.

**Why cannabis goes via Section 21** — most medical-cannabis formulations are not registered for routine SA sale, so Section 21 is the lawful pathway for a doctor to prescribe and a pharmacy to dispense them under regulatory oversight. Self-grown or private-use cannabis (decriminalised by the Cannabis for Private Purposes Act 2024) is an entirely separate framework and is not a regulated medical supply chain.