01 / Legal · South Africa
Section 21
SAHPRA’s authorisation pathway to access unregistered medicines.
02 / Definition
What is Section 21?
Section 21 refers to the provision of the Medicines and Related Substances Act under which SAHPRA may authorise a patient’s access to a medicine that is not registered in South Africa. For cannabis, a healthcare practitioner applies to SAHPRA for approval to supply a specific unregistered product to a named patient. It is a prescription-based regulatory pathway, distinct from the private members’ club model.
03 / Related terms
See also
SAHPRA
The South African Health Products Regulatory Authority.
Medical cannabis
Cannabis accessed through a regulated, prescription-based clinical pathway.
Prescription (Rx)
A practitioner’s written authorisation to supply a scheduled medicine.
Schedule 6
The high-control medicines schedule that covers most THC-containing cannabis.