You are here Home Guidance and resources Decision trees Listen Print Share LinkedIn (Twitter) Facebook Email Loading... 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 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. Is my product a medical device? Use this decision tool to help you determine if your product is a medical device. Good manufacturing practice application Use this decision tree to assist you to determine if GMP licencing or certification is required. 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. Which clinical trial scheme should I choose? Use this decision tool to decide which clinical trial scheme (CTN or CTA) you should use. 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. 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. 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. 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. 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. Food-Medicine Interface Guidance Tool (FMIGT) Use this tool to determine if your product is a food or medicine.
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 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.
Is my product a medical device? Use this decision tool to help you determine if your product is a medical device.
Good manufacturing practice application Use this decision tree to assist you to determine if GMP licencing or certification is required.
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.
Which clinical trial scheme should I choose? Use this decision tool to decide which clinical trial scheme (CTN or CTA) you should use.
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.
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.
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.
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.
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.
Food-Medicine Interface Guidance Tool (FMIGT) Use this tool to determine if your product is a food or medicine.
