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Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance
This consultation closes on 12 February 2019.
Invitation to comment
Hard surface disinfectants must meet all regulatory requirements as set out in TGO 54: Standard for Disinfectants (TGO 54) and associated guidance. This Order will sunset (cease) on 1 April 2019, therefore the TGA invites comments on their proposed update.
It is intended that the updated Therapeutic Goods Order will incorporate all relevant regulatory requirements, comprising:
- Updated sections of TGO 54 that clarify existing requirements
- The labelling requirements of the former Therapeutic Goods Order No. 37 (which has now sunset), and
- Standards and requirements contained within the Guidelines for the evaluation of disinfectants.
Hard surface disinfectants have recently been down-regulated as a result of the reform activities endorsed by Government from the Future Regulation of Low Risk Products Review. This included:
- Downregulating Registered disinfectants entries on the Australian Register of Therapeutic Goods to become Listed entries, and Listed disinfectants are now exempt, and
- Pre-market review of listed disinfectants will only be conducted on new ingredients (that are active) and/or new specific claims.
Sponsors will be advised separately of the progress of downregulation reform activities.
Further information can be found at Disinfectants & sterilants. The downregulation reforms have been implemented and are therefore not within the scope of this consultation.
TGA will consider feedback and comments relevant to the proposed update to TGO 54.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
- Consultation: TGO 54 standard for disinfectants (pdf,178kb)
- Consultation: TGO 54 standard for disinfectants (docx,96kb)
Draft: Therapeutic Goods Order: Standard for disinfectants
- Draft: Therapeutic Goods Order: Standard for disinfectants (pdf,372kb)
- Draft: Therapeutic Goods Order: Standard for disinfectants (docx,162kb)
Exempt disinfectants guidance
Listed disinfectants guidance
Document released for consultation on Tuesday 18 December 2018.
Interested parties should respond by close of business Tuesday 12 February 2019.
Feedback will be released following consideration of submissions. (See 'What will happen').
Content of submissions
Submissions may address any, or all, of the above consultation documents.
Submissions must be relevant to the proposed Therapeutic Goods Order and associated guidance documents only, noting the points made above under 'Important Note'.
In addition, submissions may include information on:
- The suitability of the test requirements and limits specified in the new Therapeutic Goods Order.
- Suggested improvements.
- Whether or not you support the proposal. If you do not support the proposal, you may make suggestions for an alternative acceptable to you.
- An assessment of how the proposal will impact on you.
How to submit
Complete the online consultation submission form to upload your submission in either pdf or word format.
Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:
Business Improvement Section
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be emailed to LowRiskDevices@health.gov.au.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.
It is proposed to re-make the Therapeutic Goods Order before the current TGO 54 sunsets in April 2019.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.