Since late 2016, the cultivation, production and manufacture of medicinal cannabis in Australia has been legal.
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.
Having successfully guided more than three quarters of the successful applicants through the ODC 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, we are well placed to help.
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.
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.
With the vast number of regulatory rules, standards and guidelines out there, it’s easy to become overwhelmed! We can help you develop a GMP compliance roadmap to guide you on your way.