Medicinal cannabis information for business and industry

Investment

Through the Victorian Medicinal Cannabis Industry Development Plan, the Victorian Government aims to create a medicinal cannabis industry that can supply half of Australia's market for medicinal cannabis by 2028.

If you are looking to invest in Melbourne and Victoria, government assistance may be available depending on the nature, size and potential location of your business. For further information, please visit the Invest Victoria website.

If you are a small business or just starting out on developing a business, a range of information and support is available through Business Victoria.

Commonwealth regulations

Cultivation and production

The cultivation and production of cannabis in Victoria for medicinal purposes or research relating to medicinal cannabis, is regulated by the Commonwealth Office of Drug Control (ODC) through its national licensing scheme under the Narcotic Drugs Act 1967. The scheme covers obtaining cannabis plants (including seeds, stems or leaves) for the purpose of cultivation, and other related activities such as supply, packaging, transport, storage, possession and control, and the disposal or destruction of cannabis plants, cannabis or cannabis resin.

Cultivation of cannabis plants includes sowing a cannabis seed, planting, growing, tending, nurturing or harvesting a cannabis plant, and grafting, dividing or transplanting a cannabis plant. Production refers to the separation of cannabis and cannabis resin from a cannabis plant.

A person or business interested in cultivating medicinal cannabis in Victoria will need to obtain both a licence and permit from the Commonwealth Office of Drug Control (ODC) to engage in the cultivation and/or production of cannabis for medicinal and/or research purposes. For information on how to obtain these licences and permits, visit the ODC's website.

The licensing and permit provisions in the Narcotic Drugs Act 1967 relating to cannabis cultivation, production and research, operate to the exclusion of State and Territory laws (unless preserved by a regulation under the Narcotic Drugs Act). This means that, provided you are granted permission to carry out cultivation by the ODC, you do not need an additional Victorian licence or permit to cultivate cannabis plants (or to obtain and possess cannabis seeds or to carry out any other activities specified on the relevant ODC cultivation licence) for the purposes of producing cannabis or cannabis resin, or to produce cannabis or cannabis resin, for medicinal or related scientific purposes. Agriculture Victoria is able to offer limited technical advice about cultivating medicinal cannabis as it relates to licensing proprietary genetics, genotyping and chemotyping of plant strains, compliance management and cannabinoid analytical services.

Manufacturing

There are Commonwealth and Victorian government regulatory requirements that a manufacturer must comply with before operating in Victoria.

Firstly, a manufacturer must obtain the Commonwealth Office of Drug Control's (ODC) licence and permit for the manufacture of medicinal cannabis under the Narcotics Drugs Act 1967. For information on how to apply for these licences and permits, visit the ODC website.

Secondly, depending on the manufacturing activity, it is likely that a manufacturer will require a Good Manufacturing Practice (GMP) licence from the Therapeutic Goods Administration (TGA). This information can be found in the manufacturing therapeutic goods section of the TGA website.

Finally, as any substance related to cannabis is scheduled under the Poisons Standard, any organisation intending to lawfully supply such substances by wholesale (and possibly conducting manufacturing activities beforehand) must obtain a Victorian poisons licence - discussed in more detail below under Victorian regulations.

Import and export

Importing medicinal cannabis into Victoria is permitted provided the relevant import licence and permit have been granted by the Commonwealth ODC.

For information on the ODC import licence and permit and how to apply, visit the importation of controlled substances section on the ODC website.

Victorian organisations seeking to export medicinal cannabis will require a licence and a permit issued by the ODC under the Customs (Prohibited Exports) Regulations 1958. The medicinal cannabis product must also be listed on the Australian Register of Therapeutic Goods. For further information on the requirements and how to apply for an export licence and permit, visit the ODC website on export of controlled substances.

Victorian regulations

Victorian licences and permits to possess (and possibly supply) scheduled substance(s)

The Department of Health helps protect the community from the potential harm of medicines and chemicals. It does this by setting boundaries for the safe storage, supply and use of scheduled substances.

As substances related to cannabis are scheduled within the Commonwealth Poisons Standard (most commonly within Schedule 4, 8 or 9), an organisation would likely require a Victorian licence or permit to be in lawful possession, or to lawfully supply such substances in Victoria. The only exception to this is where an organisation has been granted permission to carry out cultivation of cannabis by the Australian Office of Drug Control (ODC) for a Victorian site, after which, the organisation may carry out the activities specified on its ODC cannabis cultivation licence at the specific Victorian site without having to hold a Victorian poisons licence or permit (as discussed further above).

The following licences and permits are available in relation to Schedule 8 or Schedule 4 substances:

• permits to purchase or obtain for research* / industrial / advisory / educational purposes
• permits to purchase or obtain for the provision of health services
• licences to manufacture, sell or supply by wholesale
• licences for wholesale supply by indent (where the licence holder directs the wholesale supply, but does not take possession of or store the substances).

For more information regarding the different legislative controls for different schedules of medicines in Victoria, visit the Medicines and Poisons section of this website.

To apply for a Victorian licence or a permit to obtain or supply a Scheduled Substance (along with fees) visit the Licences and permits website.

Victorian licence for wholesale supply

An organisation considering selling or supplying any substances related to cannabis products by wholesale in Victoria will require a wholesale licence from DHHS.

The requirements for Victorian poisons licence are outlined within the form entitled “Apply for a new licence or permit”, which is available on the Licences and permits website.

While the following is not a complete list of all requirements of a licence holder, a licence holder must:

• nominate at least one qualified / experienced person to be named as a “responsible person” on the licence.
• comply with the requirements of the Australian Code of Good Wholesaling practice for Medicines
• have appropriate premises and procedures in place to ensure that supply, storage, security, transport, destruction and record keeping complies with legal and regulatory requirements.

A licence to supply scheduled substances DOES NOT allow the licence holder to supply scheduled substances direct to patients or members of the general public. A licence to supply scheduled substances only allows the licence holder to supply scheduled substance(s) to authorised customers, which may include:

• other persons or organisations holding a current poisons licence or permit
• authorised health practitioners, including registered medical practitioners, pharmacists working in approved pharmacies, dental practitioners and veterinary practitioners
• some other authorised persons that are specified in Regulation 7 of the current Victorian Drugs, Poisons and Controlled Substances Regulations*.

* The current Victorian Drugs, Poisons and Controlled Substances Regulations may be downloaded from the Victorian Legislation and Parliamentary Documents website.