Skip to Content

Section 21 Patient Access

A regulated pathway for accessing cannabis-based medicines in South Africa

Doctor-led, patient-specific access within a controlled regulatory framework.

A Structured Access Pathway

In South Africa, access to cannabis-based medicines is regulated under the SAHPRA Section 21 framework. This pathway allows registered medical practitioners to prescribe unregistered medicines for individual patients, subject to regulatory approval. Bassani Health operates within this framework to enable compliant, controlled access to cannabis-based medicines through recognised healthcare channels.

Understanding the Section 21 Framework

Section 21 of the Medicines and Related Substances Act permits the use of unregistered medicines under specific conditions. This includes:

  • Prescription by a registered medical practitioner
  • Submission of an application to SAHPRA
  • Approval on a patient-specific basis
  • Controlled dispensing through authorised healthcare professionals

This framework ensures that access to cannabis-based medicines is managed within a regulated and medically supervised environment.

How the Process Works

Doctor Consultation

Section 21 Application

SAHPRA Approval

Product Allocation

Pharmacy Dispensing

Patient

Step-by-Step Access


STEP 1: Medical Consultation

A registered doctor evaluates the patient and determines whether cannabis-based treatment is appropriate.

STEP 2: Section 21 Application

An application is submitted to SAHPRA for approval of the prescribed medicine.

STEP 3: Regulatory Approval

SAHPRA reviews the application and grants patient-specific approval.

STEP 4: Product Allocation

Approved products are prepared and allocated within a regulated supply chain.

STEP 5: Dispensing

The medicine is dispensed by a licensed pharmacist or authorised dispensing practitioner.

Supporting the Process

Bassani Health supports the Section 21 process through its integrated platform. This includes:


  • Supply of pharmaceutical-grade cannabis products
  • Alignment with regulatory requirements
  • Coordination across manufacturing and distribution
  • Delivery through compliant pharmacy channels
  • Ensuring consistency and quality
  • Compliance throughout the process

A Controlled, Regulated System

Cannabis-based medicines supplied under Section 21 are classified as scheduled medicines and must be handled within strict regulatory controls. Bassani Health's model ensures:


  • Product quality aligned with pharmaceutical standards
  • Product quality aligned with pharmaceutical standards
  • Compliance with SAHPRA, Department of Health, and SAPC
  • Patient safety through medically supervised access

For Healthcare Professionals and Partners

Bassani Health works with:


Medical Practitioners

Prescribing under Section 21

Pharmacies

Dispensing practitioners

Healthcare Providers

Seeking compliant pathways

Industry Participants

Transitioning to regulated frameworks

We provide structured support to enable participation within the regulatory system..

Access the Framework

If you are a healthcare provider, pharmacy, or organisation seeking to operate within the Section 21 framework, Bassani Health provides structured pathways aligned with regulatory requirements.


Start Onboarding Speak to our Team