Page 13 - Landscape SA 100

FEATURE

constructive co-operation in the field Section 22C(1)(b) of the Medicines and a great job in enabling applicants to
of GMP. PIC/S affiliation is subject to Related Substances Act 1965 (Act 101 cultivate, export and manufacture
initial and periodic assessment of the of 1965) specifies that manufacturers of cannabis and related products with the
participating authority to ensure that it medicines and related substances must applications one can apply for. We would
has equivalent legislation, regulatory and hold a licence. Section 35, Regulation 23 of like to thank them for helping to grow the
enforcement procedures, and inspection the Act specifies that to hold a licence, there South African economy and for ensuring
capacity. must be the ability to comply with good best practices and standards in this new,
manufacturing practices as determined by evolving medicinal cannabis industry.
According to Article 46b (2) of Directive the Authority. This allows for the Authority They have accomplished this despite the
2001/83/EC, active substances shall to determine manufacturing practices and pressure and work load since SAHPRA’s
only be imported if, inter alia, they are the relevant code of GMP to be applied by mandate was expanded to include
accompanied by written confirmation manufacturers. the regulation and control of radiation
from the competent authority of the emitting devices and radioactive nucleides
exporting third country, and if the Slabber adds: “The South African Health under the Medicines Act and Hazardous
manufacturing plant confirms that the Products Regulatory Authority is doing Substances Act of 1973.” LSA
standards of good manufacturing practice
and control of the plant are equivalent to
those in the European Union.
Slabber says that SAHPRA has been
very supportive, guiding their approach
and enabling this certificate to help
applicants export their flower materials
to commercial markets. The certificate
only allows cultivation, trimming, drying
and packaging, and does not constitute a
Good Manufacturing Practice license for
the processing and extraction of cannabis
and related products.
Cilo Cybin Pharmaceutical is in process of
obtaining its Good Manufacturing Practice
license for the processing and extraction
of cannabis, and has been inspected by
SAHPRA.

Landscape SA • Issue 100 2021 11