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Regulation of listed disinfectants in Australia

Guidance

How the Therapeutic Goods Administration (TGA) defines and regulates listed disinfectants, including guidance on how to submit a product application and the supporting data and other information required.

Last updated

This guidance relates to products that meet the definition of a listed disinfectant. Listed disinfectants make specific claims, as outlined in the claim guide, and must be included in the Australian Register of Therapeutic Goods (ARTG) and meet all requirements as set out in the following legislation before they can be supplied.

The following guidance contains information about:

  • information required to support your application
  • formulation
  • how to make your application in TBS
  • fees and charges
  • post-market - ongoing responsibilities

Supporting documents

Topics

Page history

Show all page updates (6)

Version 2.1: Updates due to changes in fees and charges and advertising code

Version 2.0: Updates based on TGO 104 changes for residual activity claims and minor amendments

Version 1.3: Minor updates

Version 1.2: Update box on amendment to Standard

Version 1.1: Replaced references to Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)] with Safe Work Australia's Model Code of Practice: Labelling of workplace hazardous chemicals

Version 1.0: Original publication

Version 2.1: Updates due to changes in fees and charges and advertising code

Version 2.0: Updates based on TGO 104 changes for residual activity claims and minor amendments

Version 1.3: Minor updates

Version 1.2: Update box on amendment to Standard

Version 1.1: Replaced references to Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)] with Safe Work Australia's Model Code of Practice: Labelling of workplace hazardous chemicals

Version 1.0: Original publication

This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/regulation-listed-disinfectants-australia

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