- SAHPRA — South African Health Products Regulatory Authority
Primary regulator for health products including cannabis. Issues licenses, product registrations, and Section 21 authorizations. Manages GMP compliance under PIC/S alignment.
- Cannabis product registration
- Section 21 authorization for unapproved medicines
- Schedule 7 cultivation licenses
- GMP compliance oversight
- Department of Health — Policy oversight
Policy oversight of health products regulation. Medicines and Related Substances Act 101 of 1965 is the foundational legislation.
- Medicines and Related Substances Act 101 of 1965
- National health products policy
- Oversight of SAHPRA
- SAPS — South African Police Service
Enforcement of cannabis regulations. Investigates unlicensed cultivation, distribution, and possession outside legal frameworks.
- Licensed Producers — Growing export sector
Growing export sector with climate advantage and low labor costs. SA exports to Germany, UK, and Netherlands. Must hold SAHPRA Schedule 7 license and GMP compliance.
- Patients — End recipients
End recipients of medicinal cannabis. Access via SAHPRA-registered products or Section 21 authorization for unapproved medicines.