Some sponsors may be seeking to supply disinfectants for the first time during the COVID-19 pandemic. This page answers frequently asked questions for new sponsors in relation to the supply of these products. For further guidance, see Disinfectants: Information for new sponsors.
Where can I test my disinfectant product for microbial efficacy?
All tests should be carried out by a GMP-licensed laboratory or laboratory accredited to ISO/IEC 17025 or equivalent, such as National Association of Testing Authorities, Australia (NATA), TGA, US FDA, PIC/S, US EPA, or NAMAS UK. To ensure a particular laboratory is accredited to perform the required testing, you are able to search through the NATA using the test codes references in the disinfectant testing instructions. You may also contact laboratories directly for further discussions to ensure suitability.
If you are having trouble identifying suitable laboratories, you may wish to contact a regulatory affairs consultant.
How do I include a claim against COVID-19 on the label?
Disinfectants that claim to be effective against COVID-19 will be asked to provide testing data that shows the product is effective against COVID-19, and must:
- have data that complies with the requirements of the TGA Instructions for Disinfectant Testing;
- use an acceptable surrogate virus to support the COVID-19 claim; and
- have evidence of adherence to Good Laboratory Practice.
Where can I find information about packaging and labelling requirements for my disinfectant?
Information about packaging and labelling requirements for disinfectants can be found in Division 3 of Therapeutic Goods Order 104 and Guidance for listed disinfectants.
How long does it take for the TGA to review disinfectant applications?
While there are no statutory timeframes for disinfectant reviews, the TGA is currently expediting applications for disinfectants with specific claims against the COVID-19 virus. Whilst every effort is taken to expedite these applications, we still need to ensure the products meet the requirements of safety, quality and performance.
How do I include a general claim against viruses on the label?
If you wish to include a general virucidal claim (such as "kills 99.9 % viruses"), the minimum testing requirement is testing using both poliovirus and herpes simplex. Parvovirus can be substituted for poliovirus. The TGA Instructions for Disinfectant Testing outlines the acceptable test methods.
Disinfectants that make virucidal claims are regulated as listed disinfectants.
Can I make residual effect claims on my disinfectant?
A claim of residual activity (such as "protects for up to 24 hours") is considered to be a specific claim which requires review by the TGA. Disinfectants that make specific claims are regulated as listed disinfectants. All claims made about residual effectiveness must be substantiated with suitable test data. In December 2021 the Therapeutic Goods Order 104 was updated to include a definition of residual activity. The approved methodologies, acceptance criteria and maximum claim duration for a residual efficacy claim are outlined in the TGA Instructions for Disinfectant Testing. Disinfectants that claim residual efficacy must demonstrate compliance with these requirements.
How do I add a new ingredient to the TGA ingredient database?
Ingredients included in the product's formulation must be identified using the relevant Australian Approved Names (AANs) or Proprietary Ingredient (PI) codes. If the formulation of the disinfectant contains ingredient(s) which do not have an AAN/PI you are required to submit a notification of a new proprietary ingredient form/proposed Australian Approved Name (AAN) application form.
New ingredient notifications are usually processed within 20-30 working days. Please contact tganames@tga.gov.au for more information.
Can I include virucidal claims in the labelling of a sanitiser?
If a sanitiser includes claims against viruses, unless it is specifically for food surfaces, the product will be regulated as a disinfectant.
Statements such as "kills COVID-19 virus" are specific claims. Disinfectants that make specific claims are regulated as listed disinfectants.
How can I tell if a disinfectant is approved to make claims against COVID-19?
Where can I report illegal or misleading advertisements?
If you want to make a complaint about advertising directed to the public, please visit the TGA's web page on how to make an advertising complaint.
How do I include a claim that my disinfectant is suitable for application by fogging?
For a sponsor to make a claim for fogging, specific instructions for use on how to apply the disinfectant to the room and ideally what size room could be treated should be included on the label for the disinfectant. Test data also should be submitted for review to validate the fogging method of application.
Does my disinfectant need to be manufactured in a TGA GMP licenced facility?
All disinfectants are exempt from GMP requirements under Item 13 Schedule 7 of the Therapeutic Goods Regulation 1990).