PharmOut provides companies with expert ODC Consultants to assist with medicinal cannabis licencing applications to the Australian Office of Drug Control (ODC). The ODC is responsible for issuing medicinal cannabis cultivation licences in Australia. This information overviews the basic ODC criteria for medical cannabis licence approval in Australia. It remains illegal to grow cannabis in Australia without a licence and the required permits.
A number of businesses are seeking to enter the medicinal cannabis supply industry in Australia and other countries. This has led to increasing demand for licences and guidance on site selections, greenhouse designs and engineering plans, cultivation techniques and crop management as well as production, extraction and the logistics of importing and exporting cannabis products, plants and seeds.
So what does the ODC look for when considering applications for licences for cannabis cultivation?
What’s required for businesses hoping to meet the growing domestic and international demand for high-quality medicinal cannabis production and GMP pharmaceutical products for patient care or research? There are a number of items the ODC investigates when processing medicinal cannabis licence applications.
ODC Documentation requirements for Medicinal Cannabis cultivation and production licence(s)
When applying for a medicinal cannabis cultivation licence from the Office of Drug Control (ODC), you will need to provide the following documentation with your application:
- Evidence that you are fit and proper person (they investigate criminal histories and more)
- Identification documents
- Evidence of financial stability
- A site map, showing what is in the immediate vicinity
- A detailed floor plan of any buildings on the site with a particular emphasis on security details
- A copy of any standard operating procedures and policies that will be used
- A risk management plan
What does the Office of Drug Control (ODC) look for when assessing a cannabis licence?
Getting a licence to legally grow cannabis in Australia can be a daunting, time-consuming and expensive process for companies unfamiliar with the process and requirements of medicinal cannabis cultivation and industry designs.
That’s why having an expert consultant help you with the OCD application process, documentation requirements and industry-compliant design-stages is highly recommended for medicinal cannabis licencing processes.
- The main focus of the ODC licence application assessment for medicinal cannabis is the control of the crop to ensure that no vulnerable communities, such as schools, hospitals or drug rehabilitation centres, are at risk.
- The ODC application will also be assessed from a security perspective, to ensure the necessary protections are in place to prevent unauthorized people from accessing the plants and harvested products.
- There is also an assessment of the quality management systems and other documentation that is normally found in pharmaceutical manufacture.
Research and manufacturing licence applications
The documentation listed above is also required when applying for a medicinal cannabis cultivation licence for research or manufacturing purposes. In addition, the application for a manufacturing licence must be accompanied by the following information:
- Details of the drugs proposed to be manufactured
- Details of the proposed end use of the drugs
- Record keeping arrangements, including the quantities and amount of starting material
- Information regarding products manufactured for research, clinical trials or supply to the public
How we can help with cannabis start-ups and ODC licence applications
With PharmOut’s diverse skill set and long experience, we can help you design, engineer, build and setup your cultivation and/or manufacturing site. We can also help you apply for your medicinal cannabis cultivation and production licences and permits, including state poisons and manufacturing licenses. Read more about applying for a medicinal cannabis license.
In addition, our medicinal cannabis consultants may be able to assist with a turn-key facility designs.
PharmOut consultants are in demand for their expertise in cannabis industry development projects around the world. Contact the relevant office for global cannabis industry experts and related licencing application information, documentation, engineering and design assistance.
For more on the latest news in the global cannabis industry and our Top 10 Medicinal Cannabis blogs, click here.