Guidance on the regulation of listed disinfectants in Australia
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.
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
Page history
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