Page 15 - Landscape SA 104

FEATURE

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 Co-
operation 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 About the authors
and networking between competent • training competent authorities, in
authorities, regional and international particular inspectors; Johann Slabber is a production and
organisations, thereby increasing mutual • assessing (and reassessing) inspec- regulatory expert from a pharmaceutical
confidence. This is reflected in the PIC/S’ torates; and background, and Estian Schaefer is
mission, which is to lead the international • facilitating the co-operation and a quality and regulatory expert from
development, implementation and networking of competent authorities a pharmaceutical background. They
maintenance of harmonised GMP and international organisations. were the first team to obtain a GACP
standards and quality systems of (Good Agricultural and Collections
inspectorates in the field of medicinal Conforming to the requirements of Practices) license as well as a GMP (Good
products. This will be achieved by: regulatory authorities is the first step in Manufacturing Practise) license on one
obtaining a license, but to export and site for the cultivation and processing of
• developing and promoting harmonised build a business in the cannabis industry, cannabis. LSA
GMP standards and guidance it is necessary to implement the right
documents; standards and approach with your market.

Landscape SA • Issue 104 2021 13