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Unless exempt or excluded, all medicines are required to be entered onto the ARTG before being imported into, supplied in or exported from Australia.
Check if your health product is a non-prescription medicine before you start.
The TGA only regulates therapeutic goods. If you don't have a therapeutic good, you might not need to engage with the TGA at all.
The TGA has a variety of fees and charges for non-prescription medicines:
The fees payable vary depending on the type of application. See Schedule of fees and charges to applications submitted to the TGA.
Understand the non-prescription medicine pathways
Non-prescription medicines are categorised by the ingredients they contain and the therapeutic indications they use.
Also see: Dossier requirements for non-prescription medicines
Applies to listed and assessed listed medicines only.
Certifying that your listed or assessed listed medicine meets all regulatory requirements.
All medicines on the ARTG are subject to either conditions of listing (for AUSTL or AUST LA) or registration (AUST R), such as record keeping and product recall requirements.
See: Conditions - Standard and specific
The TGA has imposed a condition on the listing of all sunscreens on the ARTG that requires testing results from AMA Laboratories are supplemented with additional justification by the sponsor in support of the efficacy of their sunscreen. The condition makes it clear that it is the responsibility of the sponsor to ensure they can substantiate the efficacy of their sunscreen where testing results from AMA Laboratories are held to demonstrate compliance with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products-Evaluation and classification (the Sunscreen Standard).
Sponsors should ensure that they:
Rather than holding additional evidence or justification, sponsors may instead consider having their sunscreens tested by an approved testing facility other than AMA Laboratories Inc. Testing conducted by an alternative facility will be considered acceptable where it meets the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products-Evaluation and classification (the Sunscreen Standard) without any additional evidence or justification needing to be provided to the TGA under the condition of listing.
The TGA Business services (TBS) portal provides an electronic facility for the listing and registration of medicines on the ARTG.
To apply for a TGA client ID and access to the TBS portal, please see TGA Business Services: getting started with the TGA.
Information regarding the various 'roles' within TBS can be found at TGA Business Services: how to use the portal under Roles: what each user can do.
The TBS portal can be accessed through your web browser.
The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
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