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Manufacture of medicinal cannabis for supply under 'approved access' provisions
Guidance on GMP compliance
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.