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 basics
Learn the basics of therapeutic goods regulation and how to find products on the Australian Register of Therapeutic Goods (ARTG).
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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. -
Fees and payments
Learn about our fees and charges, which recover the cost of regulation from industry.
Meeting requirements on your regulatory journey
Know the requirements that apply throughout your product’s regulatory journey.
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Overview of applying for market authorisation
Understand how to apply for market authorisation of therapeutic goods in Australia, including key requirements, approval processes, and regulatory considerations. -
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). -
Manufacturing
Information to assist manufacturers understand their regulatory responsibilities, including licensing. -
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Compliance and enforcement
We monitor and enforce compliance with laws that regulate health products.
Regulatory framework and reforms
Get familiar with therapeutic goods legislation and changes to the regulatory system.
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Legislation and legislative instruments
Find information about legislation, acts and regulations, legislative instruments and other legislative information. -
Product types