Entering a non-prescription medicine onto the Australian Register of Therapeutic Goods
Outline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods (ARTG).
Recently published
This page was published on [date_placeholder].
Recently updated
This page was updated on [date_placeholder]. See page history for details.
Unless exempt or excluded, all medicines are required to be entered onto the ARTG before being imported into, supplied in or exported from Australia.
-
You must have a therapeutic good
-
Be aware of fees and payments
-
Know what non-prescription medicine pathway you will follow
-
If listing your medicine - certify that your medicine meets all regulatory requirements
-
Comply with conditions of listing or registration
-
Apply to include your therapeutic good on the ARTG
You must have a therapeutic good
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.
Be aware of fees and payments
The TGA has a variety of fees and charges for non-prescription medicines:
- an initial application fee
- evaluation fees
- an annual charge to maintain the inclusion of their product in the ARTG.
The fees payable vary depending on the type of application. See Schedule of fees and charges to applications submitted to the TGA.
Know what non-prescription medicine pathway you will follow
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
If listing your medicine - certify that your medicines meets all regulatory requirements
Applies to listed and assessed listed medicines only.
Certifying that your listed or assessed listed medicine meets all regulatory requirements.
Comply with conditions of listing or registration
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
Sunscreens
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:
- hold evidence to confirm the validity and accuracy of the SPF, broad spectrum and water resistance claims for the product; and
- Provide this evidence to the TGA for evaluation and approval, when requested (within 10 working days of the request, unless otherwise agreed by the TGA, upon request by the sponsor).
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.
Apply to include your therapeutic good on the ARTG
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 site under Roles: what each user can do.
The TBS portal can be accessed through your web browser.
Guidance and resources
-
User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
-
User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
-
FormsThis form should only be used when you wish to apply for registration of a new complementary medicine that would be 'grouped' with a medicine already registered on the Australian Register of Therapeutic Goods (ARTG).
-
User guideStep by step user guide on submitting applications to register a complementary medicine (RCM) or over the counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG) in the TGA Business services (TBS).
-
User guideDetermining the route for an over-the-counter (OTC) application and assessing the risk to consumers with the umbrella brand extension.
-
User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application