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Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants (TGO 54)
Outcomes from consultation
The label requirements under subsection (2)(i)(vii) of TGO 104 will be amended to "Not for use on skin" and to apply only to products that contain the active ingredient Chlorhexidine. Compliance obligations and penalties will commence on 29 March 2021, allowing a reasonable period to implement labelling changes.
The TGA has made the new Therapeutic Goods Order 104: Standard for Disinfectants (TGO 104) to replace the previous TGO 54 'Standard for Disinfectants and Sterilants' which sunset on 1 April 2019.
The TGA has incorporated stakeholder feedback from consultation, about the proposed new TGO and its associated Guidance documents for Listed and Exempt disinfectants. TGO 104 incorporates:
- Updated sections of the previous TGO 54 'Standard for Disinfectants and Sterilants' and clarifies the requirements for hard surface disinfectants;
- The labelling requirements of the previous and TGO 37 'General Requirements for Labels for Therapeutic Devices' (which sunset on 1 October 2018); and
- Standards and requirements within the Guidelines for the evaluation of disinfectants.
As a result, these regulatory requirements are now contained within one TGO.
The TGA thanks the 21 individuals and organisations who provided valuable feedback. Stakeholders broadly supported the updated TGO, which better aligns with contemporary expectations and standards and provides clear and comprehensive guidance on the new regulatory arrangements for hard surface disinfectants. Those suggestions which maintain the TGA's requirements to ensure that disinfectants available in Australia are of an acceptable standard, have been incorporated in the final TGO and guidance materials.
Stakeholder feedback will also inform TGA's review of:
- the disinfectants pages of the TGA website, to ensure the application processes for inclusion in the Australian Register of Therapeutic Goods (ARTG) are clear for all current and potential sponsors of disinfectants; and
- the guidance documents for exempt and listed disinfectants (which will be published in late April in response to requests from stakeholders for further amendments). In the interim, the previous guidance documents provide support to sponsors for understanding the TGO.
In response to requests from stakeholders, the TGA intends to consult separately on a Standard for sterilants and disinfectants of medical devices during 2019. In the interim, sponsors may continue to comply with the appropriate sections of TGO 104 (which refers to the Guidelines for the evaluation of disinfectants) as 'state of the art'.
The TGA also intends to amend the definition of hospital grade disinfectant to more accurately reflect how these products are used outside of a medical setting, at the next review of the regulations. The TGA has allowed a transition period for sponsors to amend labels to include the warning "not for use on skin" for disinfectants that contain chlorhexidine.
Compliance obligations and penalties will commence on 29 March 2021, allowing a reasonable period to implement labelling changes.
The TGA has also responded to stakeholder feedback to improve clarity of TGO 104 by separating the previous schedules of TGO 54. These schedules are no longer included in TGO 104. Instead they are provided separately on the TGA website, to improve readability for sponsors.