In the June 2020 issue of Landscape SA, an article entitled Medicinal Cannabis Licensing was featured. However, the current cannabis industry and regulatory challenges have given rise to some confusion, and this article covers additional information on activities that can be performed under various licenses
The Medicines and Related Substances Act, 1965 (Act 101 of 1965) mandates the South African Health Products Regulatory Authority (SAHPRA) to regulate the availability of quality medicines which are safe and efficacious for their intended use. This mandate requires SAHPRA 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, SAHPRA assesses the balance between its benefits and its risks.
In terms of Sections 21 and 22A(9)(a)(i) of the Medicines Act, authorised practitioners can apply to SAHPRA 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 SAHPRA. To date, patient access to unregistered cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products.
A license to cultivate cannabis for purposes of producing scheduled substances in terms of Section 22C(1)(b) of the Medicines and Related Substances Control Act, 1965 allows an applicant to perform the following activities:
• Cultivation activities such as cloning/ seedlings, vegetation, flowering and harvesting. • Processing activities that include trimming, drying and bulk packaging of the flower material. • Testing activities that include analytical and microbiological testing of the cultivated plant/s, as well as other testing activities.
• Storage of material at the site’s premises that includes bulk storage of cannabis cultivated by the license holder and bulk seeds produced by the license holder. This may also include clones/seedlings before they are exported to the relevant licensed buyer of such products.
• Distribution activities include bulk distribution of the cannabis material cultivated by the license holder, and distribution of samples sent for testing at laboratories, as well as stability samples and quality control samples that may be required.
• Export activities include the export of bulk packaged cannabis material cultivated by the license holder. No final packaging is allowed to be performed and applicants will require a GMP (Good Manufacturing Practice) license to package, extract and/or process the cultivated cannabis material.
Additional license specifications
The cultivation license also prohibits further manipulation of the dry flower (e.g. extraction of cannabinoids) and subsequent production of a “finished product”;
Conforms to the standards of cGACP (current Good Agricultural and Collection Practices);
Waste material and rejected material of the plant, or any part of the plant must be destroyed as per SAHPRA guidelines for destruction of Schedule 6 material.
Early in 2021, the South African Health Products Regulatory Authority issued, in conjunction with the cultivation licenses mentioned above, an extension certificate. They realised that it would be very difficult for license holders to export cannabis flowers to commercial markets under the standards of Good Agricultural and Collection Practices. Therefore all current license holders received written confirmation for active substances to be exported into the European Union (EU) for medicinal products for human use. This certificate goes together with the GACP license and is based on the standards and requirements outlined in Article 46b (2)(b) of Directive 2001/83/EC.
Unfortunately, this caused a lot of confusion in the industry, where some license holders understood that they were now EU GMP licensed and/or GMP licensed; some even understood that products could now be further processed and packaged.
To summarise the above, the current license is not a GMP license or an EU GMP license, but rather a GACP license with an extension certificate to indicate compliance with an EU standard that only allows one to conduct the same activities as indicated on a cultivation license, but which assists in exporting products to commercial markets.
Explanation of a GMP license
The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. The PIC/S presently comprises 54 participating authorities from around the world (Europe, Africa, America, Asia and Australasia) and aims to harmonise inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors.
It also aims to facilitate co-operation and networking between competent authorities, regional and international organisations, thereby increasing mutual confidence. This is reflected in the PIC/S’ mission, which is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. This will be achieved by:
• developing and promoting harmonised GMP standards and guidance documents;
• training competent authorities, in particular inspectors;
• assessing (and reassessing) inspectorates; and
• facilitating the co-operation and networking of competent authorities and international organisations.
Conforming to the requirements of regulatory authorities is the first step in obtaining a license, but to export and build a business in the cannabis industry, it is necessary to implement the right standards and approach with your market.
About the authors
Johann Slabber is a production and regulatory expert from a pharmaceutical background, and Estian Schaefer is a quality and regulatory expert from a pharmaceutical background. They were the first team to obtain a GACP (Good Agricultural and Collections Practices) license as well as a GMP (Good Manufacturing Practise) license on one site for the cultivation and processing of cannabis.