Listed and assessed listed medicines: application and submission user guide

The TGA Business services (TBS) portal provides an electronic facility for the listing and registration of medicines on the Australian Register of Therapeutic Goods (ARTG). There are two pathways for listing a medicine in the ARTG:

• AUST L listed medicines are listed in the ARTG after self-certification by sponsors that all legislative requirements are met;
• AUST L(A) assessed listed medicines are listed in the ARTG after self-certification of quality and safety of the product and pre-market assessment for efficacy evidence to support the product indications..

The Act allows for cancellation of a product from the ARTG if a sponsor’s certification is incorrect.

Sponsors should have an understanding of the regulation of listed medicines in Australia and their legal obligations. For more information, refer to:

• Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
• Permitted ingredients for listed medicines guidance
• Permitted indications for listed medicines guidance
• Assessed listed medicines evidence guidelines

Accessing the TGA Business Services (TBS)

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 using either - Internet Explorer, Google Chrome, Firefox or Safari.