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Entering your product on the ARTG
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If your goods meet the requirements for listed medicines, your next step will be to submit an application to include your product in the ARTG. You can do this through the TGA Business Services (TBS).
To submit an application, you should follow these steps:
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Obtain access to TBS and get a client identification number. See Getting started with the TGA for more information.
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Enter the details of your medicine and fill out the application. You can find more information on this process at: Listing a complementary medicine on the ARTG.
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Once you submit an application and you have received an AUST L number, you may import, export and supply the goods. There are fees associated with an application for a listed medicine application as well as ongoing charges to keep your product in the ARTG. These can be found in the schedule of fees and charges under non-prescription medicines.
If you need help with your application, refer to the listed medicines application and submission user guide.
Remember that it is the responsibility of the sponsor to ensure the goods remain compliant with all relevant legislation at all times.
Where to go for more help
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides information on the regulation of complementary medicines in Australia.
The SME Assist page contains general guidance for small to medium businesses, start-ups and those unfamiliar with regulation of therapeutic goods.
You may wish to seek the services of a regulatory affairs consultant to assist you with submitting an application.
If you require assistance throughout the listing process and afterwards, please contact the TGA.