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.
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Cultivation and production
The cultivation and production of medicinal cannabis in Victoria is regulated by the Commonwealth Office of Drug Control (ODC) through its national licensing scheme under the Narcotic Drugs Act 1967.
Cultivation refers to the growing of cannabis plants and includes all steps up to, but not including, harvest (defined as removal of flowers/resin from plants). Production refers to harvesting, extraction, and the placing of this product in a container for the purpose of manufacture or research.
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.
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.
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's 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 medicinal cannabis products are classified as either Schedule 8 or Schedule 4 controlled drugs, a manufacturer may also require a Victorian licence to obtain, possess, sell or supply a controlled substance - which are discussed in more detail below under Victorian regulations. A Victorian licence is not required if these activities are exempt or completely covered by the ODC licence.
Import and export
Importing medicinal cannabis into Victoria is permitted provided the relevant import licence and permit have been granted by the Commonwealth ODC. The importer will also need to hold a Victorian licence allowing possession and wholesale supply of cannabis material (discussed below under Victorian Regulations) before import approval may be granted by the 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 licences and permits to possess, sell and supply a controlled substance
The Department of Health and Human Services helps protect the community from the potential harm of medicines and chemicals. It does this by setting boundaries for the safe storage, prescribing, supply and use of scheduled medicines.
As most medicinal cannabis products are classified as either Schedule 8 or Schedule 4 controlled drugs in the Australian Poisons Standard, a manufacturer will also require a Victorian licence to obtain, possess, sell or supply a controlled substance, in situations where these activities are not exempt or fully covered by the Commonwealth ODC licence.
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 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 section of this website.
Victorian licence for wholesale supply
An organisation considering selling or supplying medicinal cannabis products by wholesale in Victoria will require a wholesale licence from DHHS.
In addition, an organisation considering storing an imported product in a third party warehouse will require an Victorian indent wholesale licence.
Wholesale licence applicants must:
- nominate a responsible, qualified, and experienced person to be named on the licence. Minimum requirements that apply to a nominated Responsible Person can be found in the Responsible Person Application Form
- understand the Australia-wide Code of Good Wholesaling practice for Medicines
- have appropriate premises and appropriate processes and procedures in place to ensure that the supply, storage, security, transport, destruction and record keeping in relation to the scheduled substance is in accordance with all legal and regulatory requirements.
Wholesale licence applicants may be required to provide information showing that they have satisfactory knowledge and understanding relevant to the supply of medicinal cannabis products by wholesale. This may be demonstrated by providing a detailed business plan demonstrating:
- the nominated person's relevant qualifications or experience handling Scheduled Substances, and
- their knowledge and understanding of relevant regulatory requirements for supplying medicinal cannabis products by wholesale, and
- how they intend to obtain and distribute medicinal cannabis products, and
- how the proposed site is suitable for the purpose of supplying medicinal cannabis products.
NOTE: 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.