Medical Cannabis In Sa: What Section 21 Means

Understanding Section 21: The Only Legal Pathway for

Medical Cannabis Access in South Africa

Most South Africans have heard of medical cannabis. Far fewer understand how it legally reaches a patient. Bassani Health explains the framework and why getting it right matters.

South Africa’s cannabis industry has no shortage of operators claiming to serve the medical market. But there is a significant difference between selling cannabis products and legally supplying pharmaceutical-grade cannabis medicine to a patient under a doctor’s care. That difference comes down to one framework: Section 21.

For most people outside the industry, and many inside it, Section 21 remains poorly understood. That lack of clarity has allowed a wide range of operators to position themselves as “medical” without ever engaging the framework properly. Bassani Health believes it is time to change that.

What Is Section 21?

Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) is a provision that allows the South African Health Products Regulatory Authority (SAHPRA) to authorise the use of an unregistered medicine for a specific patient, under the care of a specific doctor, on a case-by-case basis.

It is not a cannabis-specific mechanism. It exists across the broader pharmaceutical landscape and has been used for decades to provide access to medicines that have not yet completed formal registration in South Africa but have demonstrated therapeutic value elsewhere. In the absence of registered cannabis-based medicines in South Africa, Section 21 has become the primary legal route through which pharmaceutical-grade cannabis can reach a patient today.

The process works as follows: a licensed medical practitioner identifies a patient who may benefit from a cannabis-based medicine. The doctor submits a formal application to SAHPRA, motivating the clinical need and specifying the product, dosage and quantity required. SAHPRA reviews the application and, if approved, issues a Section 21 authorisation letter. That letter is patient-specific, doctor-specific and time-limited, typically valid for six months.

Critically, the authorisation does not end there. The product itself must be sourced, handled, packed, labelled and dispensed through fully licensed channels. This is where most operators fall short.

Why Implementation Is the Hard Part

Understanding Section 21 conceptually is straightforward. Implementing it correctly is not. To do so legally, an operator needs a very specific set of permits, all active simultaneously.

First, a SAHPRA Section 22C cultivation licence is required to legally grow cannabis for medicinal purposes. Second, a Section 22C(1)(b) Manufacture and Packer licence is required to process and, critically, to package and label finished pharmaceutical products. The packer designation within this licence is frequently overlooked, but it is not optional. Packaging and labelling of a finished medicine is a regulated pharmaceutical activity, and without this specific authorisation, it cannot be done legally. Third, a Department of Health manufacturing pharmacy licence is required to operate a manufacturing pharmacy facility. Fourth, a South African Pharmacy Council pharmacy grading certificate confirms that the dispensing facility meets the standards required for pharmaceutical-grade supply.

All four must be in place simultaneously. A gap in any one of them breaks the legal chain. And that legal chain is what separates a properly implemented Section 21 supply from one that exists in a grey area, regardless of how it is marketed.

The Structural Reality of the Market

Bassani Health holds all four permits. It is, to our knowledge, the only cannabis operator in South Africa that does. That is not a marketing claim. It is a structural reality of a licensing environment that has been deliberately difficult to navigate, requiring years of regulatory engagement, significant capital investment and an unwavering commitment to doing things correctly.

The company has invested over R330 million in building and licensing its Midrand facility to pharmaceutical standards, incorporating GACP and GMP principles across cultivation, extraction, formulation and packaging. The result is a seed-to-patient platform that can implement the Section 21 framework in full, from the moment a doctor submits an application to the moment a patient receives their medicine through a licensed pharmacy.

Bassani Health has already received SAHPRA-approved Section 21 authorisations, with licensed medical practitioners prescribing products including high-potency THC formulations to specific patients. The framework is not theoretical. It is operational.

What This Means for Doctors, Patients and the Industry

For medical practitioners, Section 21 offers a legitimate, SAHPRA-sanctioned route to prescribe cannabis-based medicines to patients who may benefit from them, without waiting for formal product registration. The process is more involved than a standard prescription, but the pathway exists and is being used.

For patients, it means access to pharmaceutical-grade cannabis medicine, properly dosed, properly labelled and properly dispensed, through a licensed pharmacy. Not a wellness product. Not a grey-market supplement. A medicine.

For the industry, it means that the bar for legitimately claiming to operate in the medical cannabis space is considerably higher than many current operators acknowledge. As SAHPRA’s enforcement posture develops and the regulatory environment matures, that gap between genuine compliance and the appearance of it will become increasingly difficult to ignore.

Operationalising the Mandate Today

South Africa has a pharmaceutical cannabis mandate. The framework to begin delivering on it already exists. Bassani Health has built the platform to implement it, bringing legally manufactured, GMP-certified pharmaceutical cannabis to licensed entities for safe and compliant distribution to every patient across the nation, operationalising that mandate today, without waiting for 2027.

The question for the market is no longer whether medical cannabis is legal in South Africa. It is whether the operators claiming to serve that market are doing so within the law. Section 21 provides the answer. The permits tell the story.

Ends.

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