MEDICINAL CANNABIS LICENSING

Two previous articles on cannabis have appeared in Landscape SA:  The Cannabis Conundrum and Greenhouse Technology for Cannabis. This article, by Johann Slabber of the Pharmaceutical Compliance Association, looks at legally obtaining a medicinal cannabis license.

Since the guidelines were published in 2017 through the Medicines Control Council, now known as SAHPRA (South African Health Products Regulatory Authority), many applicants applied to obtain their section 22C licenses to cultivate medicinal cannabis for the international market.

Johann Slabber, CEO of the Pharmaceutical Compliance Association, says that many applicants “jumped in too quickly” and were misguided by so called experts within the industry who offered assistance with site development, license application submissions and quality systems etc. This led to massive investments that were lost and money spent unnecessarily.

According to Slabber, the requirements of regulatory authorities and obtaining a license is only the first step of the process;  standards involve quite another approach if one wants to ensure an exportable product without limitations to markets, and sales of such products. Slabber assisted a few applicants through the entire process to obtain their licenses

successfully, and he is now an accredited Inspectorate with the support of an independent international company that provides EU GACP (1) accreditation as well as EU GMP (2) inspection audits. This is done to declare the compliance of specified standards and to ultimately trigger the qualified person to issue relevant licenses.

“SAHPRA has been very supportive and an instrumental guide to help me obtain understanding and experience in the right approach for the licensing of cannabis.  I would like to sincerely thank them for their hard work,” he states.

Legally obtaining a cannabis license

Slabber explains that in order to legally obtain a cannabis license in South Africa, the applicant (person or company) would have to apply via the guidelines set out in Section 22C of Act 101, 1965 – the Medicines and Related Substances Control Act. Currently there are two applications available: the aforementioned, which is a license valid for five years to cultivate medicinal cannabis for local and commercial markets. The reason one is not able to sell high concentrates locally is due to the fact that no active dossiers have been registered. The second application is Section 22 A, which is a permit available for research and development, and which is valid for 12 months.

There are many grey areas surrounding the licensing of cannabis – some of these concern the scheduling of specified cannabinoids, as well as the law for the registration of seeds, which does not really exist at this stage. Import and export permits have also only recently been introduced.

There is also confusion around the fact that government-enacted and exemption of specified hemp and cannabinoids is to be announced soon. At the moment, CBD is classified as Schedule 4, and THC as Schedule 6. Hemp is also Schedule 4 due to its cannabinoid profile as well as its THC, and the fact that hot conditions increase the amount of THC in hemp. 

  

  1. GACP = Good Agricultural and Collections Practice     
  2. GMP = Good Manufacturing Practice

About the author

Johann Slabber is registered with the South African Pharmaceutical Council. He is an entrepreneur with a pharmaceutical and business background, specialising in the pharmaceutical regulatory and compliance industries globally. He has obtained his EU GACP and EU GMP accreditation to conduct preliminary audits in Africa through independent regulatory authorities internationally, and is currently undertaking his BCom Hons International. He is also a representative of some of the leading medicinal cannabis manufacturers in Europe.

Slabber has extensive experience in the retail, wholesale, distribution and manufacturing sector, and is currently CEO of the Pharmaceutical Compliance Association.

In future articles, Slabber will discuss the importing and exporting of cannabis, as well as the wide variety of cannabis seeds and strains.

For further information contact him on 078 101 2288.

Caption: Johann Slabber, CEO of the Pharmaceutical Compliance Association