Regulations for all products

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information for all products.

Regulation essentials

A general introduction to therapeutic goods regulation in Australia.
Overview of applying for market authorisation

Overview of the process to follow if you want to supply therapeutic goods in Australia
Fees and payments

Learn about our fees and charges, which recover the cost of regulation from industry.
Manufacturing

Information to assist manufacturers understand their regulatory responsibilities, including licensing.
Ingredients and the scheduling of medicines and chemicals

Information on types of ingredients and approved names, the Permissible Ingredients Determination and the Poisons Standard (the SUSMP).
Labelling and packaging

Make sure your labels and packaging meet our requirements.
Advertising

Find out if the regulations for advertising of therapeutic goods apply to you.
Import and export

Learn how the regulation of therapeutic goods applies to importing and exporting.
About the Australian Register of Therapeutic Goods (ARTG)

The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. You can search the ARTG to find details of therapeutic goods approved for supply.
Legislation and legislative instruments

Find information about legislation, acts and regulations, legislative instruments and other legislative information.
TGA reforms

Information on our regulatory and business process reforms.
Compliance and enforcement

We monitor and enforce compliance with laws that regulate health products.

Product types

Product regulation