Page 14 - Landscape SA 104

FEATURE

CANNABIS LICENSES

AND CERTIFICATION

BY JOHANN SLABBER AND ESTIAN SCHAEFER, CILO CYBIN

PHARMACEUTICAL

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.

he Medicines and Related Substances of the Medicines and Related Substances
Act, 1965 (Act 101 of 1965) mandates Control Act, 1965 allows an applicant to
Tthe South African Health Products perform the following activities:
Regulatory Authority (SAHPRA) to regulate
the availability of quality medicines which • Cultivation activities such as cloning/
are safe and efficacious for their intended seedlings, vegetation, flowering and
use. This mandate requires SAHPRA to harvesting.
apply standards for the manufacture, • Processing activities that include
distribution, sale and marketing of trimming, drying and bulk packaging
medicines, medical devices and scheduled of the flower material.
substances. In considering the availability • Testing activities that include analytical Additional license specifications
of any medicine for human or animal use, and microbiological testing of the
SAHPRA assesses the balance between its cultivated plant/s, as well as other The cultivation license also prohibits
benefits and its risks. testing activities. further manipulation of the dry flower (e.g.
• Storage of material at the site’s extraction of cannabinoids) and subsequent
In terms of Sections 21 and 22A(9)(a)(i) of premises that includes bulk storage production of a “finished product”;
the Medicines Act, authorised practitioners of cannabis cultivated by the license
can apply to SAHPRA for permission holder and bulk seeds produced by the Conforms to the standards of cGACP
to access and prescribe unregistered license holder. This may also include (current Good Agricultural and Collection
medicines when intended to treat clones/seedlings before they are Practices);
individual patients. Cannabis-containing exported to the relevant licensed buyer
products intended for medicinal purposes of such products. Waste material and rejected material of
may thus be made available, in exceptional • Distribution activities include bulk the plant, or any part of the plant must be
circumstances, to specific patients under distribution of the cannabis material destroyed as per SAHPRA guidelines for
medical supervision. Authorisation cultivated by the license holder, and destruction of Schedule 6 material.
is dependent on the submission of distribution of samples sent for testing
an appropriate dosage regimen, an at laboratories, as well as stability Early in 2021, the South African Health
acceptable justification for the proposed samples and quality control samples Products Regulatory Authority issued,
use, and regular reporting to SAHPRA. that may be required. in conjunction with the cultivation
To date, patient access to unregistered • Export activities include the export licenses mentioned above, an extension
cannabis or cannabinoid-containing of bulk packaged cannabis material certificate. They realised that it would be
medicines has been enabled by SAHPRA cultivated by the license holder. No final very difficult for license holders to export
through importation of these products. packaging is allowed to be performed cannabis flowers to commercial markets
and applicants will require a GMP under the standards of Good Agricultural
A license to cultivate cannabis for (Good Manufacturing Practice) license and Collection Practices. Therefore all
purposes of producing scheduled to package, extract and/or process the current license holders received written
substances in terms of Section 22C(1)(b) cultivated cannabis material. confirmation for active substances to be

12 Landscape SA • Issue 104 2021