Medicinal Cannabis Legality and Business Sector in Australia: Since late 2016, the cultivation, production and manufacture of medicinal cannabis in Australia has been legal. Licencing and permits are required; licencing requires ODC approval and GMP production requires TGA approvals. PharmOut has been leading ODC consultants, helping industry successfully gain ODC licences. Contact us for international cultivation engineering, design and GMP expertise including licencing, site selection and documentation requirements for licencing.
In January 2018, the federal government announced its intent to allow exports of Australian Medicinal Cannabis in the future, however, there is currently no framework to support this at this stage in time. Regulations are yet to change – especially to the Narcotic Drugs Regulation 2016.
Our architects, engineers and scientists are ready to provide process designs and optimal layouts as well as obtaining planning approvals and regulatory approvals by completing the appropriate documentation for all aspects of your Australian Medicinal Cannabis ODC License or TGA Manufacturing License.
We have successfully guided more than three-quarters of the successful applicants through the ODC licensing process as well as the first TGA manufacturing license issued to an Australian Medicinal Cannabis producer. We have not yet failed to guide a company through the ODC and TGA process, as the leading Australian ODC Consultants, we feel that we are well placed to help you.
From October 2016, the Australian Office of Drug Control (ODC) began processing license applications for the cultivation, production and manufacturing of medicinal cannabis. Australia has a well established opioid industry and the regulators are rightfully careful to control the access to cannabis so that it is utilised solely for medical purposes.
The main focus of the Australian ODC licence application is an assessment of the control over the crop, as well as people. This is to ensure that no vulnerable communities are at risk and that no unauthorised people are able to access the plants.
Two manufacturing licences will be required for the manufacture of Medicinal Cannabis in its Active Pharmaceutical Ingredient form.
PharmOut offers GMP project management services to help you get a project up and running as well as compliant with the relevant regulations.
Our pharmaceutical architects and engineers have extensive experience in designing a wide variety of pharmaceutical, medical device and complementary medicine manufacturing and distribution facilities.
If you already have a facility design, we can provide an independent Design, ODC, and GMP review to make sure that all the important details are covered and nothing has been missed.
PharmOut offers a range of services and products aimed at delivering QMS compliance for medical cannabis manufacturers.
PharmOut offers a wide range of Validation, GLP, GDP and GMP training courses online, onsite, as well as in a city near you. We also offer a 1 day intensive Australian Medicinal Cannabis Training Course aimed at all staff working in Medicinal Cannabis cultivation and production and manufacturing facilities.