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Listed and assessed listed medicines: Application and submission user guide

21 March 2019

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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:

Listed and assessed listed medicines: Application and submission user guide

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Contents

  • Introduction
  • Accessing the TGA Business Services (TBS)
  • How to login
  • Creating new listed and assessed listed application
  • Navigating through an application
  • Other application types
  • Validating an application
  • Submission
  • Preparing to make an application
  • Trouble shooting in the TBS portal

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