Medical cannabis became legal in Australia, but strictly controlled from November 2016.

The Narcotic Drugs Act was amended in parliament on 24 February 2016 to permit the legal cultivation of cannabis for the manufacture of medicinal cannabis products in Australia. The Amendment Bill essentially allows licensing and permit schemes to be established for the cultivation and production of cannabis and cannabis resin for medicinal and scientific purposes. Subsequently, the usage of medicinal cannabis was legalized at the federal level on 1 November 2016.

To grow medical cannabis legally, you will need to apply for a manufacturer licence and then secure a permit. As explained in the Bill:

A manufacture licence may authorize the manufacture of a drug and activities related to such manufacture, including manufacture for the purposes of research relating to medicinal cannabis products. Before a licence holder can manufacture a drug, the licence holder must obtain a manufacture permit. Permits deal with matters such as the types and quantities of drugs that can be manufactured.   Certain conditions are imposed on all manufacture licence holders and the Secretary may impose additional conditions.

Australia cannabis business operations are regulated by the Office of Drug Control and the Therapeutic Goods Administration with individual states and territories having their own rules about who can prescribe it and which patients can access it.

The export of medicinal cannabis products was legalized in February 2018 through the Narcotic Drugs Amendment (Cannabis) Regulations 2018.

Provided domestic supply of medicinal cannabis is not affected, the following products are eligible for export if granted a license and permit to export:

  • Medicinal cannabis products manufactured in Australia under a GMP license.
  • Medicinal cannabis products listed as export-only, or registered, on the Australian Register of Therapeutic Goods (ARTG)
  • Extracts of cannabis (or extracts of cannabis resin) manufactured under a Narcotic Drugs Act 1967 license and permit that are not in the final dosage form.

Australia Cannabis Business Licenses

There are four types of licences relating to the supply of medicinal cannabis products available:

  • medicinal cannabis licence authorising cultivation or production or both
  • cannabis research licence authorising similar process for research purposes
  • manufacturing licence authorizing the manufacture of a drug or product
  • importer.

You need to apply to the Australian Office of Drug Control (ODC). The Department will then decide whether to grant, or refuse to grant, the licence.

Licence holders will need to ensure crops are carefully secured and accounted for so as not to be diverted to illicit uses. The Amendment Bill goes into greater detail and is essential reading for anyone who is considering applying for a licence.

Application Process:

  1. Potential growers have to pass the Office of Drug Control’s “fit and proper person” test
  2. Another thing the Office of Drug Control will consider is whether or not the business can stay stable and secure. For example, applicant must prove that he’s got agreements with manufacturers that are willing to take the raw cannabis crop and turn it into medical cannabis products.
  3. Additionally, there are strict regulations around how much security the crop will require – while it’s growing, being transported, and even analysed.
  4. The Office of Drug Control also issues permits which strictly outline the type (and quantity) of cannabis that can be cultivated.

Licensing Fees and Charges

The following fees apply to applications received by the ODC for licences and/or permits for the cultivation, production or manufacture of cannabis.

AssessmentFee ($)
Application for a medicinal cannabis licence5,290
Application for a cannabis research licence5,290
Application for a manufacture licence0

In addition to licence fees and inspection fees (an average inspection fee is $7,050), there are statutory charges which are in place to cover non-direct cost recovery of activities associated with licences. This includes the conduct of unannounced inspections, administrative processing of minor operating procedure variations lodged by licence holders, and other activities need to maintain the licencing scheme.

The quantum of charge for a licence is as follows:

  1. for a medicinal cannabis licence – $27,360 for each period of 12 months, or part of a period of 12 months, for which the licence is in force;
  2. for a commercial cannabis research licence – $27,360 for each period of 12 months, or part of a period of 12 months, for which the licence is in force;
  3. for a non commercial cannabis research licence – $27,360 for the period for which the licence is in force.

As of January 2024, a total of 127 licences were issued under the scheme: 48 medicinal cannabis licences (commercial cultivation and production), 44 cannabis manufacture licences and 35 importer licences.

Australian Cannabis Market



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