Cultivation, manufacture, and wholesaling in Queensland
The cultivation, manufacture and wholesaling of medicinal cannabis products in Queensland is tightly regulated by a combination of Commonwealth and state-based schemes.
The Therapeutic Goods Administration (TGA) specifies that products supplied in Australia must meet the following:
- Good Manufacturing Practice (GMP)
- Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) (TGO 93).
These requirements will deliver consistent, contaminant-free and high-grade medicinal cannabis products, which is essential to ensure health practitioners make reliable and safe prescribing and dosage decisions.
The Commonwealth Government has responsibility for regulating the cultivation, production, manufacture, importation and export of medicinal cannabis products and all licences and permits will be provided by the Office of Drug Control (ODC). Domestic cultivation is subject to strict security requirements, because of the high risk of raw cannabis plants being used for unlawful purposes.
Industrial cannabis (Cannabis sativa) production in Queensland is managed under Part 5B of the Drugs Misuse Act 1986 and Part 4 of the Drugs Misuse Regulation 1987. For more information on producing, processing and marketing industrial cannabis in Queensland contact the Department of Agriculture and Fisheries, Biosecurity Queensland on 13 25 23 or visit business.qld.gov.au.
To enable the manufacture of medicinal cannabis products in Queensland, two separate Commonwealth processes need to be completed simultaneously.
- The Therapeutic Goods Administration (TGA) specifies that products supplied in Australia have to meet an acceptable standard of Good Manufacturing Practice (GMP). A manufacturer will need to demonstrate they meet GMP and have established procedures to ensure therapeutic goods are of high quality, please refer to the Manufacturing standards for medicinal cannabis.
- All persons interested in manufacturing narcotic drugs require a licence and permit to manufacture from the Office of Drug Control (ODC), please refer to the manufacturers section of the ODC's website.
Queensland Health will be notified of cultivation and manufacturing applications that are well progressed, so any Queensland licencing processes can be coordinated and progressed in a timely manner. No Queensland manufacturing licence is required as long as the mandatory TGA and ODC licences are in place. In the meantime, all enquiries should be forwarded to the Office of Drug Control.
The Commonwealth Government made legislative changes to allow for the bulk importation of medicinal cannabis products for therapeutic use in Australia. For further information about importation of medicinal cannabis product please see the Office of Drug Control’s website.
For a sponsor to be able to provide these products through a pharmacist or doctor in Queensland a wholesaling licence needs to be in place. In Queensland, medicinal cannabis wholesaling is regulated through the Medicines and Poisons (Medicines) Regulation 2021.
Sponsors based in another State or Territory that use a Queensland based wholesaler to distribute products on their behalf will also require a Queensland wholesale licence to store their product at the site in Queensland. That site is named on their licence. The TGA has specific requirements for this type of “distribution” arrangement, that requires the sponsor to maintain direct control of the product, please see Supply and wholesaling of medicinal cannabis products (MCP).
What you need to know
You need to make an application for a wholesaling licence – medicines.
The following documents are provided to support the application process:
- Application form: Application for a wholesaling licence – medicines (PDF 538 kB)
- Factsheet: Medicinal Cannabis Wholesalers (PDF 137 kB)
- Factsheet: Manufactures – medicine (PDF 312 kB)
How to apply
You will need to submit an application form to wholesale medicinal cannabis in Queensland.