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Medicinal Cannabis in Australia

The cultivation, production and manufacture of medicinal cannabis drugs has been legal in Australia for over a year.

Recently, the federal government announced its intent to allow exports of 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 the Narcotic Drugs Regulation 2016.

While the regulatory terrain is still shifting, here’s what you need to know, how to comply, and how we can help you:

Medical Cannabis Manufacturing in Australia

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.

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.

Project Management

PharmOut offers GMP project management services to help you get a project up and running as well as compliant with the relevant regulations.

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.

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.

More Information:

If you have any questions you would like to ask, please contact us here.

If you want to read more about medicinal cannabis, why not check out our blogs?