South Africa is one of only three African countries that permit the cultivation of medical cannabis, enabling its citizens to capitalise on the increasing market for both the recreational and medical uses of the plant. Following the ruling of the Constitutional Court in 2018, cannabis has been decriminalized, however, there are still very few laws that regulate its industrialization. This grey area in the law makes it extremely difficult to obtain compliance to farm cannabis in the country.
Licenses for cannabis production in South Africa can be obtained, however, the processes to get them are strict and costly. A report published from Landbouweekblad estimates that the cost of setting up the production facility, along with preparing for the application will cost between R3 million to R5 million. It’s also important to ensure you have a contract in place with an international buyer before beginning the application process.
How to get a cannabis license in South Africa
The South African Health Products Regulatory Authority (SAHPRA), is required to regulate the availability of quality medicines, which are safe and efficacious for their intended use. Thus, this mandate requires SAHPRA to create and monitor regulations for the production, distribution, selling and marketing of medicines and scheduled substances, including cannabis. A business must obtain a licence from SAHPRA and the Department of Health for the following activities:
- Cultivation and production of cannabis and cannabis resin
- The extraction and testing of cannabis
- Manufacturing a cannabis/cannabinoid-containing medicine
- The importation of cannabis containing medicine
- The exportation of cannabis containing medicine
- The distribution of cannabis containing medicine
To approve the license, SAHPRA will need to conduct a full inspection of the plans for the production facility and the proposed quality control procedures to be implemented. Furthermore, applicants are also required to apply to the Director-General of Health for a permit to comply with the provisions of Section 22A(9)(a)(i) of the Medicines Act to acquire, possess, manufacture, use or supply cannabis for medical use.
Maintaining a cannabis license in South Africa
To maintain your cannabis license, strict record-keeping procedures must be in place. A license holder must ensure that information created, sent and received in the course of running their business is stringently recorded for the following purposes:
- Fulfilment of the obligations under licence conditions
- Corporate memory and repeatable decision making
- Ensuring the integrity of information assets
- Facilitating business stability in regards to employee turnover
- Responding to auditing or inspector requirements (including unannounced inspections)
- Meeting and maintaining the security arrangements stipulated in the license agreement
Applicants must also implement a robust documentation system that will allow for the recording of all processes and procedures which may affect the quality of the product for each batch produced by the business. These records must include the following information:
- The location and name of the person in charge of the cultivation
- Details of the previous crops grown in that location
- Nature, origin and quantity of the herbal starting materials
- The chemicals used during the cultivation process
- An irrigation water analysis
- Standard cultivation conditions
- The particular circumstances of the cultivation
- Nature and quality of the yields
- Drying conditions for the crops
- Measures for pest control
- Reports of soil conditions
The cultivating process for cannabis in South Africa is currently quite lengthy given the fact the government is yet to address the industrialisation of the cannabis plant. However, as the panic of the COVID-19 pandemic starts to subside, the hope is that parliament will start working on regulations and laws that mitigate the current extensive process of obtaining a cannabis license.