Section 21 Registration
SECTION 21 – PATIENT INTAKE FORM
- Section 21’s:
Before any medicine can be sold in South Africa, it must be approved by the South African
Health Products Regulatory Authority (SAHPRA), who certifies that the medicine is safe, of
good quality and is effective.
Unless the medicine has gone through these processes, it cannot be on the shelves for sale.
In exceptional circumstances, SAHPRA may permit access to unregistered medicines. This
exception is permitted by section 21 of the Medicines and Related Substances Act, 101 of
1965 through a process that is commonly referred to as “a section 21 application”.
- Dispensing of Medicinal Cannabis:
Under the Medicines Act, medical practitioners can apply to SAHPRA for permission to
access and prescribe unregistered medicines – including cannabis – for their patients in
certain exceptional circumstances.
The only means by which a patient will be able to obtain Medicinal Cannabis in South Africa
is through a medical practitioner who holds the relevant license to prescribe it, which license
is obtained from SAHPRA.
A Pharmacist registered accordingly with the relevant Pharmacy Council are able to provide
medicinal cannabis when provided with a legitimate prescription from a medical practitioner.
Medicinal Cannabis products may thus be made available to specific patients under medical
supervision and through legal channels as confirmed by SAHPRA in the guideline document
in this regard.
- Supporting Documents Required:
– Notification of Payment
– Copy of ID
– Selfie Photo