Cannabis Cultivation Licences

Last Updated 31 January 2025

In terms of section 22C(1)(b) of the Medicines and Related Substances Control Act 101 of 1965 (Medicines Act), the South African Health Products Regulatory Authority (SAHPRA) is empowered to issue a licence, on application and payment of the prescribed fee, to a manufacturer, wholesaler, or distributor of a scheduled substance to manufacture, import, export, act as a wholesaler of or distribute such scheduled substance.

A section 22C(1)(b) licence is required to:

Cultivate/grow and produce Cannabis and Cannabis resin;
Extract and test Cannabis, Cannabis resin, and/or cannabinoids;
Manufacture a Cannabis-containing or cannabinoid-containing substances;
Import Cannabis-containing substances;
Export Cannabis-containing substances; and/or
Distribute a Cannabis-containing substance.

An applicant must meet various requirements to acquire such a licence, including:

Having a strictly controlled farm/facility already established/built and available for inspection;
Having third-party agreements with seed banks, waste management companies, laboratory testing facilities, and off-take agreements.

Applications may be made based on a site plan before the construction of a facility. Upon completion, the facility will be inspected for compliance with all requirements.

Fees

As published in Government Gazette No. 44026 of 22 December 2020, the latest regulations regarding fees payable in terms of the provisions of the Medicines Act, the prescribed licence fees are as follows:

R25 200 for a licence to cultivate cannabis for medicinal purposes
an inspection fee of R1 600 per hour
a hardcopy licence collection fee of R3 400

Application to Director-General of Health for a permit

In addition to the licence application to SAHPRA, applicants are required to apply to the Director-General of Health for a permit in terms of the provisions of Section 22A(9)(a)(i) of the Medicines Act to manufacture cannabis for medicinal use.

Section 22A(9)(a)(i) of the Medicines Act states:

"No person shall - acquire, use, possess, manufacture, or supply any Schedule 7... substance, or manufacture any... Schedule 6 substance unless he/she has been issued with a permit by the Director General for such acquisition, use, possession, manufacture, or supply..."

There are no restrictions on the number of licences that SAHPRA may issue, except that the overall quantities of substance produced in South Africa may not exceed the quota allocated by the International Narcotics Drug Control Board (INCB).

The permit system ensures that quotas issued by the INCB are adhered to. Permits will be managed fairly, relative to the expected usage in the country, to prevent the accumulation of cannabis or cannabis products.

SAHPRA, together with the Department of Health, will order the seizure and destruction of any cannabis produced by a licence holder when the quantity conditions of the license are not adhered to.