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Approvals and authorities

Medicines and poisons are regulated substances, and the Department of Health issues licenses that cover their manufacture, distribution, sale and use. We also consider applications for other regulated activities with medicines and poisons, such as research and the use of drugs and poisons in different settings, or for treatment, known as approvals. These activities are regulated under the Health (Drugs and Poisons) Regulation 1996.

The Department of Health provide forms and guidelines for certain regulated activities and sites.

Regulated activities approval forms

Approval forms for scheduled substances for therapeutic purposes 

Industry specific approval form

Approval forms for scheduled substances for non-therapeutic purposes

Universities use the Application for an Approval to use scheduled substances for non-therapeutic purposes at a university (DOC 502 kB) form to submit an application to use medicines and/or poisons for research or teaching purposes.

Outside of university and other activities

There are a number of other regulated activities that may also be performed with approval from the Chief Executive, Department of Health, known as a 'Section 18 approval'. Use the Application for an approval to obtain, possess, and use scheduled substances for non-therapeutic purposes (other than at a university) (DOC 536 kB) form if you wish to apply for an approval to do an activity with scheduled substances outside of university or that is not addressed in the approvals above.  If you are unsure please contact us, before completing this form.

Obligations and requirements

There are obligations to report lost or stolen scheduled substances. Find out who has to report losses or theft and what types of scheduled medicines are required to be reported to the Department of Health.

Last updated: 5 December 2017

Contacts

Medicines Regulation and Quality - information on forms for therapeutic purposes
Phone: 3708 5264
Email

Environmental Hazards Unit - general contact information
Phone: 3328 9310
Email

Health Protection Licensing Unit - for approvals
Email