Section 21 authorisation

Section 21 of the Medicines and Related Substances Act allows SAHPRA to authorise the use of an unregistered medicine for a specific patient when a registered alternative is not available or suitable. Your specialist applies for it. It is a legitimate route arranged by clinicians — it is not a way for patients to import medicines themselves.

Also known as: Section 21, named patient authorisation, unregistered medicine authorisation

Last reviewed: 8 September 2026. Written by the Antega Editorial Team. General information only — always follow the advice of your own clinic, doctor or pharmacist.