Medicinal Cannabis Australia – Legality and Business Sector: 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. PharmOut also has international medicinal cannabis cultivation experts for architecture, facility and processing designs and GMP training. Our expert cannabis consultants and production engineers can assist you with all stages of your cultivation and production or exportation business, from seed to final packaging and exportation. Contact us for international cultivation engineering, design and GMP expertise including licencing, site selection and documentation requirements for licencing.
Exportation Legality of Medicinal Cannabis in Australia
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.
Our expert PharmOut cannabis consultants can help you with your ODC applications through to facility architecture and engineering, cultivation processes, trimming, drying and milling, extraction processes and other aspects of the 12 stages of medicinal cannabis production and wholesale distribution.
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.
Australian Medicinal Cannabis Manufacturing | Cannabis Consultants
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.
Obtaining a Cultivation Licence for Medicinal Cannabis in Australia
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.
Applying for Licences to Manufacture Medicinal Cannabis – API
Two manufacturing licences will be required for the manufacture of Medicinal Cannabis in its Active Pharmaceutical Ingredient form.
Applying for Licenses to Manufacture Medicinal Cannabis – FDF
Two manufacturing licences will be required for the manufacture of Medicinal Cannabis in its Final Dosage Form.
PharmOut offers GMP project management services to help you get a project up and running as well as compliant with the relevant regulations.
Facility Design & Planning
Our pharmaceutical architects and engineers have extensive experience in designing a wide variety of pharmaceutical, medical device and complementary medicine manufacturing and distribution facilities.
Facility Design Reviews
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.
TGA Regulatory Affairs Consultants
If you’re looking to supply your products to the Australian market but are unsure on the surrounding regulations, we can support you every step of the way.
Quality Management System
PharmOut offers a range of services and products aimed at delivering QMS compliance for medical cannabis manufacturers.
Medicinal Cannabis – GMP Training
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 comprehensive Medicinal Cannabis eLearning Training Series aimed at all staff working in Medicinal Cannabis cultivation and production and manufacturing facilities.
Top 10 Blogs | Global Cannabis Industry
Browse the Top 10 Blogs covering the Medicinal Cannabis Industry and Global Cannabis business sectors including CBD and importing or exporting cannabis
Online GMP Training
PharmOut offers online GMP training for employees in Pharmaceutical, Veterinary medicine production and more.
If you have any questions you would like to ask, please contact us at one of the PharmOut offices.
If you want to read more about medicinal cannabis in Australia, why not check out our blogs?