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Cultivation, manufacture, and wholesaling in Queensland

The cultivation, manufacture and wholesaling of medicinal cannabis products is tightly regulated by a combination of Commonwealth and Queensland Government schemes.

TGA standards

The Therapeutic Goods Administration (TGA) specifies that products supplied in Australia have to meet both the:

These requirements will deliver consistent, contaminant-free and high-grade medicinal cannabis products, which is essential to ensure medical practitioners make reliable and safe prescribing and dosage decisions.

Cultivation

The Commonwealth Government has responsibility for the cultivation and importation 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.

The Queensland Government regulates the cultivation of industrial hemp products. Queensland Health is working with the Department of Agriculture and Fisheries to investigate how Queensland industries can participate in the new Commonwealth licencing scheme.

Wholesale

The Commonwealth Government made 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 an importer to be able to provide these products through a pharmacist or doctor in Queensland a wholesaling approval needs to be in place. In Queensland, medicinal cannabis wholesaling is regulated through the Public Health (Medicinal Cannabis) Regulation 2017.

Please note this is also a requirement for wholesalers based in other Australian jurisdictions that will be providing products to Queensland based pharmacies and doctors.

What you need to know

As part of this application we require a Medicinal Cannabis Management Plan (MCMP) that will outline how you will manage the wholesale of medicinal cannabis products from your facility. The following documents are provided to support the application process:

How to apply

You will need to submit an application form to manufacture and wholesale medicinal cannabis in Queensland.

Manufacture

To enable the manufacture of medicinal cannabis products in Queensland, 2 separate Commonwealth processes need to be completed simultaneously.

  1. The Therapeutic Goods Administration (TGA) specifies that products supplied in Australia have to meet Good Manufacturing Principles (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 principles for medicinal products.
  2. All persons interested in manufacturing narcotic drugs require a licence to manufacture from the Office of Drug Control (ODC), please refer to the manufactures section of the ODC’s website.

As part of the process of gaining an approval in Queensland, the applicant will need to demonstrate that these processes have been commenced with an inspection of the facility to take place before an approval can be finalised.

Queensland Health will be notified of cultivation and manufacturing applications that are well progressed so Queensland approval processes can be coordinated and progressed in a timely manner. In the meantime, all enquiries should be forwarded to the Office of Drug Control.

How to apply

You will need to submit an application form to manufacture medicinal cannabis in Queensland.

Last updated: 19 November 2018