BIOSAFETY SOUTH AFRICA

Facilitating Responsible Bio-Innovation

Cannabis Compliance Navigator

Your Guide to South Africa's Cannabis Regulatory Framework

Cannabis Regulation in South Africa

Purpose: This compliance navigator serves as a reference tool to help stakeholders identify which regulatory bodies govern different cannabis activities, understand applicable legislation, and access direct pathways to licenses, permits, and regulatory information.

📋 Scope of this Navigator

This infographic outlines the current cannabis regulatory framework in South Africa, covering key authorities, compliance pathways, legislative milestones, and operational requirements for various cannabis-related activities.

🔍 How to Use

Navigate compliance through understanding applicable legislation, identifying relevant regulatory authorities, securing necessary permits, and maintaining alignment with evolving regulatory requirements across different cannabis activity categories.

🎯 Objective

To support stakeholders in the cannabis industry — cultivators, processors, researchers, and distributors — in achieving full regulatory compliance with South Africa's evolving legislative landscape.

Key Regulatory Authorities

SAHPRA

South African Health Products Regulatory Authority – Controls medical cannabis products, manufacturing licenses, and product registration.

SAHPRA Cannabis Licensing ↗

Department of Health

Oversees medical cannabis programs, public health aspects, and authorization for distribution and research activities.

Visit DoH ↗

Department of Agriculture (DoA)

Regulates hemp (low-THC cannabis) cultivation under the Plant Improvement Act through a permit system. Previously known as DALRRD.

Hemp Guidelines ↗

Department of Justice

Responsible for legislative framework, enforcement of cannabis laws, and oversight of drug trafficking provisions under relevant Acts.

Visit DoJ ↗

DSTI

Department of Science, Technology and Innovation (previously DSI) – Supports cannabis biotechnology research and innovation ecosystems.

Visit DSTI ↗

Parliament of South Africa

Legislative oversight through the Parliamentary Monitoring Group, tracking cannabis-related bills, amendments, and regulatory developments.

Visit PMG ↗

Industry Activity Categories

The following categories represent different types of commercial cannabis activities in South Africa. Each requires specific licenses, permits, and compliance with distinct regulatory frameworks depending on the intended use — medical, industrial, or research.

Steps to Regulatory Compliance

1

Understand Applicable Legislation

Identify which laws apply to your specific cannabis activity. South Africa's regulation involves multiple legislative instruments.

2

Define Your Activity Scope

Determine your operational focus: industrial hemp, medical products, commercial cultivation, research, or processing.

  • Medical Cannabis – Requires Section 22C(1)(b) license from SAHPRA ↗ + Section 22A(9)(a)(i) permit from DoH/SAHPRA
  • Industrial HempDoA permit required ↗ for cultivation of cannabis with ≤0.2% THC content
  • Research Activities – Coordinated through appropriate regulatory bodies; typically SAHPRA and DoH
  • Commercial Processing – Multi-authority oversight required; consult SAHPRA and DoA
3

Secure Required Permits

Obtain all necessary permits from relevant authorities before commencing operations.

4

Monitor Regulatory Updates

Stay informed about changes in cannabis legislation and regulatory guidance.

⚖️ Cannabis for Private Purposes Act (7 of 2024)

The Cannabis for Private Purposes Act decriminalises the private cultivation and use of cannabis by adults in private spaces. It does not legalise commercial trade. Trafficking, supply, and commercialisation remain regulated activities requiring appropriate permits and licensing.

Private use: Decriminalised Commercial sale: Still regulated Age limit: Adults only Public use: Restricted
View Full Act (PDF) ↗

Regulatory Evolution Overview

Cannabis Regulation Timeline in South Africa

1965
Foundation

Medicines and Related Substances Act

Act 101 of 1965 amended to include cannabis-derived substances under scheduling framework, establishing SAHPRA's regulatory authority over pharmaceutical cannabis.

View Act 101 of 1965
1992
Scheduling

Drugs and Drug Trafficking Act (140 of 1992)

Cannabis listed in Schedule 2 of this Act, establishing the criminal framework for cannabis. This Act continues to govern trafficking and commercial offences.

View Act 140 of 1992
2018
Landmark

Constitutional Court Ruling – Prince Case

Landmark judgment decriminalising private adult use and cultivation of cannabis. The Constitutional Court gave Parliament 24 months to remedy legislative defects.

Read Court Judgment
2020
Commercial

Medical Cannabis Cultivation Licences Issued

The Department of Health issued first commercial licences for medical cannabis cultivation, marking the beginning of South Africa's regulated medical cannabis industry.

DoH Cannabis Licensing
2022
Guidelines

SAHPRA Medical Cannabis Cultivation Guidelines

SAHPRA published detailed cultivation guidelines for licensed operators, establishing GMP standards, security requirements, and compliance inspection protocols.

View SAHPRA Guidelines
2023
Industrial

Industrial Hemp Framework Consolidated

The DoA consolidated its hemp permit system under the Plant Improvement Act, formalising the ≤0.2% THC threshold for industrial hemp and streamlining the HP-Form-001 application process.

DoA Hemp Guidelines
2024
Enacted

Cannabis for Private Purposes Act (7 of 2024)

Signed into law, formally decriminalising private cannabis use and cultivation by adults in private spaces. Commercial trade and supply remain controlled activities.

View Act 7 of 2024
2025–26
Ongoing

Continued Regulatory Development

Ongoing public consultation processes and regulatory amendments are in progress. Stakeholders are encouraged to monitor government gazettes and SAHPRA bulletins for the latest updates.

Government Gazettes