Glossary
Medicines and Related Substances Act 101 of 1965
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The foundational SA statute governing all medicines, scheduling, and the Section 21 unregistered-medicines mechanism.
The Medicines and Related Substances Act 101 of 1965 is the primary piece of South African legislation governing medicines, medical devices, scheduling, prescription rules, and advertising restrictions. It has been amended substantially over decades but remains the foundational statute. Key sections relevant to medical cannabis prescribing include:
- **§21** — the legal mechanism that lets SAHPRA authorise patient access to medicines not registered for general sale in SA. This is the legal foundation of the entire medical-cannabis pathway. - **§22A** — sets out scheduling rules and prescription requirements (which medicines need a doctor's prescription, which need pharmacy-only sale, which are over-the-counter). - **§18C** — prohibits direct-to-public advertising of prescription medicines and prescription-only treatments. This is why patient-facing content from telemedicine providers must be educational rather than promotional. - **§22(15)(a)** — scheduling-status legal authority, allowing the Minister to publish scheduling Gazettes (e.g. Gazette 43347 creating the low-dose CBD Schedule 0 carve-out).
The Act sits alongside HPCSA Rule 27 (doctor-conduct rules) to form the regulatory framework within which Docto24 operates.
Related terms
- Section 21SAHPRA authorisation for access to unregistered medicines — the primary legal pathway for medical cannabis in SA.
- SAHPRAThe South African Health Products Regulatory Authority — the regulator of medicines and medical devices.
- HPCSAThe Health Professions Council of South Africa — registration and professional-ethics regulator for medical practitioners.
- Government Gazette 43347The 2020 SA Government Gazette that created the Schedule 0 carve-out for low-dose CBD.