Licences and permits
Medicinal Cannabis is a highly regulated controlled substance.
It is a requirement under the Drugs, Poisons and Controlled Substances Act 1981 to have an authorisation (such as a licence and a permit) to obtain, possess, sell or supply any controlled substance in Victoria.
The Australian Standard for the Uniform Scheduling of Medicines and Poisons currently classifies most medicinal cannabis products as either Schedule 8 or Schedule 4.
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).
Information on how to apply for a Victorian licence or a permit to obtain or supply a Scheduled Substance (along with fees) can be found on the Licences and permits section.
Schedule 8 and Schedule 4 poisons are only available to patients holding a valid prescription, issued by an authorised, registered health practitioner, and dispensed by that health practitioner or via a pharmacy. Where the Schedule 8 or Schedule 4 substance is 'unapproved' by the Therapeutic Goods Administration (most medicinal cannabis products are 'unapproved') - additional Commonwealth approvals may be required.
None of the Victorian licences or permits above allow the supply of scheduled substances direct to patients or members of the general public.
Licences for wholesale supply
An organisation considering selling or supplying medicinal cannabis products by wholesale in Victoria will require a wholesale licence from the Victorian Medicines and Poisons Regulation.
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.
The importation of medicinal cannabis products or cannabis for medicinal purposes in Australia is exclusively regulated by the Commonwealth government. The Office of Drug Control website provides information.
It is necessary to hold a state licence before applying for a Commonwealth Import Licence. According to the Office of Drug Control website, an 'importer must establish that they are permitted to supply medicinal cannabis products within their state/territory. As prescription only controlled drugs, the importer must provide the relevant licences/approvals to possess/supply the drugs to be imported at the time of the licence application'.
Cultivation and manufacturing
The cultivation of cannabis for medicinal purposes is regulated by the Commonwealth government under the Narcotic Drugs Act 1967. In order to legally cultivate cannabis for medicinal purposes a licence from the federal Office of Drug Control is required.
Further information can be obtained on the Office of Drug Control website.
The manufacture of medicinal cannabis is also regulated at the Commonwealth level. Before manufacture can occur you must hold both a manufacturing licence and permit granted by the Commonwealth Office of Drug Control. It is not a prerequisite to hold a state licence before applying for a Commonwealth Manufacturing Licence. The relevant forms and guidance materials are available on the manufacturers section of the Office of Drug Control website.