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FEATURE

MEDICINAL Johann Slabber, CEO of the
Pharmaceutical Compliance
Association
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.

ince the guidelines were published in “SAHPRA has been very supportive and
2017 through the Medicines Control an instrumental guide to help me obtain
SCouncil, now known as SAHPRA understanding and experience in the right
(South African Health Products Regulatory approach for the licensing of cannabis. I
Authority), many applicants applied would like to sincerely thank them for
to obtain their section 22C licenses to their hard work,” he states.
cultivate medicinal cannabis for the
international market. Legally obtaining a cannabis Schedule 6. Hemp is also Schedule 4 due
license to its cannabinoid profile as well as its THC,
Johann Slabber, CEO of the Pharmaceutical and the fact that hot conditions increase
Compliance Association, says that many Slabber explains that in order to legally the amount of THC in hemp.
applicants “jumped in too quickly” and obtain a cannabis license in South Africa,
were misguided by so called experts the applicant (person or company) would 1. GACP = Good Agricultural and
within the industry who offered assistance have to apply via the guidelines set out Collections Practice
with site development, license application in Section 22C of Act 101, 1965 – the 2. GMP = Good Manufacturing Practice
submissions and quality systems etc. This Medicines and Related Substances Control
led to massive investments that were lost Act. Currently there are two applications About the author
and money spent unnecessarily. available: the aforementioned, which is
a license valid for five years to cultivate Johann Slabber is registered with the
According to Slabber, the requirements medicinal cannabis for local and South African Pharmaceutical Council. He
of regulatory authorities and obtaining a commercial markets. The reason one is is an entrepreneur with a pharmaceutical
license is only the first step of the process; not able to sell high concentrates locally is and business background, specialising
standards involve quite another approach due to the fact that no active dossiers have in the pharmaceutical regulatory and
if one wants to ensure an exportable been registered. The second application is compliance industries globally. He has
product without limitations to markets, Section 22 A, which is a permit available obtained his EU GACP and EU GMP
and sales of such products. for research and development, and which accreditation to conduct preliminary
is valid for 12 months. audits in Africa through independent
Slabber assisted a few applicants through regulatory authorities internationally, and
the entire process to obtain their licenses Five licenses were issued from 2017 to is currently undertaking his BCom Hons
successfully, and he is now an accredited 2019, and from 2019 to the first quarter of International. He is also a representative
Inspectorate with the support of an 2020, a further six were issued. of some of the leading medicinal cannabis
independent international company manufacturers in Europe.
that provides EU GACP (1) accreditation There are many grey areas surrounding
as well as EU GMP (2) inspection audits. the licensing of cannabis – some of these Slabber has extensive experience in
This is done to declare the compliance concern the scheduling of specified the retail, wholesale, distribution and
of specified standards and to ultimately cannabinoids, as well as the law for the manufacturing sector, and is currently
trigger the qualified person to issue registration of seeds, which does not CEO of the Pharmaceutical Compliance
relevant licenses. really exist at this stage. Import and export Association.
permits have also only recently been
As acting CEO, MD and COO in various introduced. In future articles, Slabber will discuss the
companies locally and internationally, importing and exporting of cannabis, as
Slabber is motivated to export the first There is also confusion around the fact well as the wide variety of cannabis seeds
high grade cannabis to the international that government-enacted and exemption and strains. LSA
market through resolution letters that of specified hemp and cannabinoids is
have been successfully issued through to be announced soon. At the moment, For further information contact
SAHPRA in South Africa. CBD is classified as Schedule 4, and THC as Johann Slabber 078 101 2288

8 Landscape SA • Issue 94 2020