SAHPRA licensing for medical cannabis production - eucatech Store

SAHPRA licensing for medical cannabis production

There have been many advances for the cannabis industry in South Africa over the past few years and one being the ability to obtain a license from SAHPRA to cultivate cannabis for medical research purposes. The use of IoT can aid in meeting compliance for license approval.

Cannabis Compliance

South Africa has decriminalized cannabis for personal use, but commercial cannabis is not yet legal for the recreational market. However, the country has a thriving medical marijuana program that relies heavily on Canadian suppliers. If you do want to become a licensed cannabis producer in South Africa, you must follow strict regulations set by the South African Health Products Regulatory Authority (SAHPRA). Having the right IoT systems in place plays an important role in reaching these compliance standards.

IoT and Compliance Standards

The use of IoT in the cannabis industry can help meet compliance standards by ensuring that the cannabis is being produced according to regulations. IoT sensors can be used to monitor temperature, humidity, CO2, and soil moisture, light sensitivity sensors, among other environmental conditions during cultivation, curing and storage. This can help prevent bud rot, white powdery mildew, and other harmful moulds, ensuring that the cannabis is safe for consumption. IoT can also help ensure that the product reaches the intended destination while staying within the regulated temperatures, for this a temperature data logger can be used when shipping.

Chroni Co is a leading example of medical cannabis production in South Africa, they make use of our IoT products and services take a look at a case study of their operation here.

cannabis iot

Getting a Cannabis License in South Africa

If you want to become a licensed cannabis producer in South Africa, you must follow the regulations set out by SAHPRA. These regulations state that you must apply for a license to cultivate, import, export or manufacture cannabis or cannabinoid containing products. If you're interested in producing cannabis for medicinal use, you'll need to apply for licenses in advance. The licenses can be obtained by submitting a site plan and site master file before construction of the facility even begins.

marijuana and a gable

However, it's important to note that once the facility is built, it will be inspected to ensure that all requirements are met. In addition to applying for a license from SAHPRA, you'll also need to seek a permit from the Director-General of Health. This permit is necessary to comply with the provisions of Section 22A(9)(a)(i) of the Medicines Act, which allows for the acquisition, possession, manufacture, use, or supply of cannabis for medicinal purposes.

Compliant Record-Keeping Procedures

To meet compliance standards, record-keeping procedures must be in place. The regulatory framework outlines record-keeping procedures that match up closely with the pre-existing Canadian model. This includes stipulations that a license holder should ensure that information created, sent, and received in the course of conducting their business is appropriately recorded.

"As part of the application process you are required to provide the details of the record keeping arrangements in place." 

The Nvirosense platform, which is listed with SAHPRA (CFR21 Part11) for Pharmaceutical Compliance as well as Perishable Products Export Control Board (PPECB) for the freshly produced and cold storage market, has back up and secure data communication via an embedded web sever, the web server Quality Intelligence Centre (QIC) reporting auto facilitates temperature and humidity mapping reports which will streamline aspects of record keeping.

A Bright Future

South Africa's medical marijuana program is thriving, but there are strict regulations in place for those who want to become licensed cannabis producers. Compliance with these regulations is essential for ensuring that the cannabis is produced safely. The use of IoT products from EUCA can help meet these compliance standards by monitoring the environmental conditions during the production process. If you would like more information on the IoT products that can be used in cannabis production, please reach out.

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