Glossary
Section 21
SAHPRA authorisation for access to unregistered medicines — the primary legal pathway for medical cannabis in SA.
Section 21 of the Medicines and Related Substances Act 101 of 1965 allows the South African Health Products Regulatory Authority (SAHPRA) to authorise access to medicines that are not yet registered for general sale in South Africa. Each Section 21 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. Medical cannabis products in South Africa are overwhelmingly accessed via this pathway rather than via routine registration.
Related terms
- SAHPRAThe South African Health Products Regulatory Authority — the regulator of medicines and medical devices.
- Named Patient Application (NPA)A Section 21 application for a single, identified patient.
- Multiple Patient Application (MPA)A Section 21 application grouping several patients with the same indication and product.