Manufacturing of medicinal cannabis
Once you make the decision to start a medicinal cannabis manufacturing business, there are several steps to follow before you can legally operate in Victoria.
Take a look at each of the sections below for all the information you'll need to get started, including information about requirements before you apply for the relevant licence.
- The Regulatory Requirements
- Before Applying
- Applying for a Licence/permit
- Licence/permit process
- Application Cost
- Further Information
The Regulatory Requirements
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.
Secondly, 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 most medicinal cannabis products are currently classified as either Schedule 8 or Schedule 4 products in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), a manufacturer may need to obtain a Victorian licence to possess, sell or supply by wholesale from the Victorian Drugs and Poisons Regulation unless their activities are exempt or completely covered by the ODC licence and permit.
There are several regulatory factors to consider when you are preparing to become a licensed Australian manufacturer of medicinal cannabis. They include:
- The medicinal cannabis products must be manufactured to the relevant GMP standard.
- An applicant must demonstrate that supply of the product will be controlled and in accordance with the existing TGA access pathways
- The export of medicinal cannabis (extracts and preparations) is not permitted unless the product is listed as export-only or registered on the Australian Register of Therapeutic Goods (ARTG) and the exporter holds a licence and permit to export drugs from the Office of Drug Control.
- Import of cannabis material is permitted for manufacture of medicinal cannabis products, subject to Victorian and Commonwealth approvals.
Manufacturers are suggested to gain an understanding the Possession, sale and supply of medicinal cannabis in Victoria requirements and the ODC's guidelines on applying for a manufacturing licence for narcotic drugs before applying for these licences.
Applying for licences/permits
ODC Manufacturing Licence and Permit
You can download, fill out and submit the manufacturing licence application form to the ODC. Contact details are provided on the application form. Guidance on the details required in the application are also available from the ODC website to assist with the application process.
This application process is to be followed if you are applying for a standalone licence to manufacture narcotic drugs derived from cannabis and/or cannabis resin. If you are also applying for a cannabis licence (cultivation, production and/or research), you should visit the medicinal cannabis section of at the ODC website and use the online smart form to complete your application electronically.
To apply for a GMP licence from the TGA, the first step is to register with the TGA to access its business portal and then apply for the licence through the portal. Visit the TGA website on how to get started and follow the step-by-step guide on Australian manufacturing licences and overseas GMP certification. A PDF copy of the step-by step guide is also available for download.
When you are ready to apply for a Victorian licence for the manufacture, sale or supply by wholesale medicinal cannabis, visit the DHHS website and complete the smart application form electronically.
The Victorian licence is usually issued for a period of 12 months.
Key considerations when applying for a Victorian licence
- Schedules 4 and 8 medicines will need to be compliant with requirements outlined in section 74 of the Drugs, Poisons and Controlled Substances Regulations 2017
- An independent security audit is required for Schedule 8 medicines. The DHHS website has a list of Independent Security Advisors that provide audit services in Victoria
- A record keeping system for supply of scheduled products is required.
The ODC processes applications on a first in, first served basis. If your application requires further information, its processing may be halted until the required information has been received. Note that information sought by ODC from other government agencies may affect the processing time.
The applicant may only commence manufacturing activities once the licence has been granted from the ODC and relevant Victorian requirements have been met.
There are currently no fees imposed by the ODC for the application of manufacturing licences. Visit the ODC website for the latest schedule of ODC fees and charges.
There are fees and charges applicable for obtaining licences for the manufacture, sale or supply by wholesale of Schedule 4 and Schedule 8 medicinal cannabis products in Victoria. You can view the latest Victorian fees and charges schedule from the DHHS website.
The ODC publishes a list of the latest licensed medicinal cannabis manufacturers and suppliers in Australia.
For information about medicinal cannabis manufacturing licenses, please contact the ODC on:
Tel: 02 6232 8740
Fax: 02 6203 1740
If you have any queries regarding the Victorian licenses and permits for Manufacture and sale or supply by wholesale of Schedule 4 and Schedule 8 medicinal products, please contact the Drugs and Poisons Regulation on:
From 10:00 am to 4:00 pm Monday to Friday (except for public holidays)
Tel: 1300 364 545
Fax: 1300 360 830
Page last updated: 11 January 2019