Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions

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This guidance is for sponsors and manufacturers considering manufacturing non sterile
medicinal cannabis products for supply under provisions of access to medicines that have not
been approved for general use, including medicinal cannabis for clinical trials.
This guidance does not apply to medicinal cannabis products that are listed or registered on the
ARTG (Australian Register of Therapeutic Goods).

Multiple laws
Medicinal cannabis is subject to the Therapeutic Goods Act 1989 as well as the Narcotic Drugs Act
1967 that are both administered by the Department of Health. In addition to that, relevant states
and territory legislation applies. These legislative frameworks work together while allowing for
different jurisdictional objectives.
States and territory governments have a role through medicine scheduling and particular
requirements on how controlled drugs including medicinal cannabis may be authorised for use
in their jurisdiction.
The Department of Health regulates medicinal cannabis products through:
· the Office of Drug Control (ODC), which administers the Narcotic Drugs Act that regulates
controlled substances to prevent diversion and illicit use
· the TGA, which administers the Therapeutic Goods Act that regulates, amongst others, the
quality, safety and efficacy of medicines as well as access to medicines that have not been
approved for general use.
For information and guidance on the regulation of medicinal cannabis products as a controlled
substance under the Narcotic Drugs Act, refer to the Office of Drug Control website.


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