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Manufacturers will need to meet the conditions outlined in their medicinal cannabis licence and have a relevant permit in order to manufacture medicinal cannabis products. The conditions aim to protect patient safety by ensuring the production of high-quality products.
A medicinal cannabis licence can authorise manufacture of a cannabis drug for one or more permitted supplies.
A permit allows you to undertake the activity you are authorised for under your licence. A permit is additional to your medicinal cannabis licence, you must apply for permits separately. Permits will set out the types and amount of cannabis plants, cannabis or cannabis resin that can be grown and/or produced, and the types and quantities of cannabis drug that can be manufactured, under a licence.
The medicinal cannabis products authorised to be manufactured will be those supported by clinical evidence. The determining factor will be products that approved medical prescribers are willing to prescribe, noting that state/territory and Therapeutic Goods Administration (TGA) approvals will then be required for their supply. See Prescribing unapproved drugs for more information.
Relevant authorities
Manufacturing of medicinal cannabis products is subject to provisions under the Therapeutic Goods Act 1989 (the TG Act) regulated by the TGA, as well as any relevant state or territory legislation. Potential manufacturers must ensure that they comply with all legislative requirements before commencing manufacturing operations. See our related authorities page for contact details.
The Office of Drug Control (ODC) does not regulate the manufacturing standards of medicinal cannabis. The TGA is responsible for governing and regulating the manufacturing standards of medicinal cannabis products in Australia.
For further information about the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order see the Medicinal cannabis hub on the TGA website.
Under the Therapeutic Goods Act 1989, a Good Manufacturing Practice (GMP) licence is required from the TGA and this will regulate the standards for activities such as; production, processing, assembling, packaging, labelling, storage, sterilisation, testing and release for supply.
For further information about GMP, see the Manufacture of medicinal cannabis page on the TGA website.
See our Frequently asked questions about medicinal cannabis for more information about manufacture.