Decision trees
Use decision trees to check rules for therapeutic goods in Australia, including classification, reporting obligations, advertising requirements and supply pathways.
Medicines
Understand the steps and documents involved in listing a medicine in the Australian Register of Therapeutic Goods (ARTG) and how a medicine shortage may impact patient care.
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What do I require to have a listed medicine in the ARTG?
Sponsors of listed medicines (AUST L), use this decision tool to understand what is required to have your listed medicine in the Australian Register of Therapeutic Goods (ARTG). -
What is the patient impact of my medicine shortage and do I have to report it to the TGA?
Sponsors of medicines, use this decision tool to determine the patient impact level of a shortage (or an anticipated shortage) of products and if you need to report it.
Medical devices
Determine whether your product is a medical device under Australian law and what classification it falls under based on risk and intended use.
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Is my product a medical device?
Use this decision tool to help you determine if your product is a medical device. -
What classification is my medical device?
Use this decision tree to work out the classification of the medical device you want to sell or supply in Australia. -
Does UDI apply to my device
Use this decision tree to determine whether Unique Device Identification (UDI) requirements apply to the devices you supply in Australia. -
When does UDI apply to my device
Use this decision tree to determine when Unique Device Identification (UDI) requirements are mandatory for the devices you supply in Australia.
Check if your product is a therapeutic good
Determine if your product is a therapeutic good, food or sports supplement under Australian law based on its ingredients, claims, labelling and intended use.
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Is my product a therapeutic good?
Use this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good. -
Food-Medicine Interface Guidance Tool (FMIGT)
Use this tool to determine if your product is a food or medicine. -
Is my sports supplement a therapeutic good?
Use this decision tree to help you determine if your sports supplement is declared to be a therapeutic good.
Unapproved goods and compliance
Establish how you may access an unapproved therapeutic good in Australia, based on the product type and circumstances of use.
Check if a particular therapeutic good can be legally advertised in Australia, based on its type, approval status and the applicable requirements under Australian law.
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Accessing unapproved therapeutic goods tool
Health practitioners, use this guide to determine which pathway, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme, is appropriate to use. -
Can I advertise this therapeutic good to the public?
Use this decision tree to help you understand if you can advertise a particular therapeutic good to the public.
Good Manufacturing Practice
Decide whether you need a Good Manufacturing Practice (GMP) licence or certification in Australia, and what evidence you'll need to provide for a GMP clearance application based on your manufacturing activities.
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Clearance Application Assistance Tool
Use the GMP Clearance Application Assistance Tool (CAAT) to assist in determining the general evidence requirements for your GMP clearance applications. -
Good manufacturing practice application
Use this decision tree to assist you to determine if GMP licencing or certification is required.