CULTIVATION OF CANNABIS AND MANUFACTURE OF CANNABIS-RELATED PHARMACEUTICAL PRODUCTS FOR MEDICINAL AND RESEARCH PURPOSES
The Medicines Control Council of South Africa releases its 2017 guidelines and framework for cultivating, processing and manufacturing of Cannabis for medicinal use in South Africa.
Are you wanting to buy or sell Cannabis/Marijuana/Dagga in South Africa?
Are you wanting to get a licence to grow Cannabis/Marijuana/Dagga in South Africa?
Are you wanting to get a licence to buy or sell Cannabis Oil in South Africa?
Then this is information on Cannabis in South Africa you’ll need to read.
The Medicines and Related Substances Act, 1965 (Act 101 of 1965), herein referred to as the Medicines Act, mandates the Medicines Control Council (MCC) to regulate the availability of quality medicines which are safe and efficacious for their intended use. This mandate requires the MCC to apply standards for the manufacture, distribution, sale and marketing of medicines, medical devices and Scheduled substances. In considering the availability of any medicine for human or animal use, the MCC assesses the balance between its benefits and risks. In terms of Sections 21 and 22A(9)(a)(i) of the Medicines Act, authorised practitioners can apply to the MCC for permission to access and prescribe unregistered medicines when intended to treat individual patients. Cannabis-containing products intended for medicinal purposes may thus be made available, in exceptional circumstances, to specific patients under medical supervision. Authorisation is dependent on the submission of an appropriate dosage regimen, an acceptable justification for the proposed use, and regular reporting to the MCC. To date, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by the MCC through importation of these products. In order to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products, the Department of Health and the MCC may permit the cultivation of Cannabis solely for medicinal and research purposes. This framework, developed in consultation with the Department of Agriculture, Forestry and Fisheries (DAFF), is intended to control the cultivation, production and manufacturing of Cannabis-containing products intended for medicinal use in South Africa. Licensed domestic cultivation of Cannabis for medicinal use is aimed at ensuring sufficient local supply for medical, scientific and clinical research purposes and the implementation of control measures necessary to prevent diversion and misuse, as well as to ensure patient safety. This guideline provides information relating to the standards required for the cultivation and processing of Cannabis as a herbal starting material and identifies the critical production steps that are needed to ensure a product of reliable and reproducible quality.
Read more at the pdf below.