05/13/2021 | News release | Distributed by Public on 05/12/2021 20:21
Introduction
An overview of how products commonly known as disinfectants and sterilants are defined and regulated can be found on the TGA website. The following guidance relates to products that meet the definition of an exempt disinfectant. Exempt disinfectants are not required to be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied, but must still meet all regulatory requirements as set out in the following legislation:
Depending on the ingredients of your product, you should also ensure that your disinfectant product meets the requirements under:
Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP, as they are covered by Safe Work Australia's Labelling of workplace hazardous chemicals - Code of Practice(link is external).
Note
If you have a problem with a disinfectant, please tell us about it.
It is an offence to import and/or supply therapeutic goods in Australia that do not conform with a standard applicable to the goods (refer sections 14 and 14A of the Therapeutic Goods Act 1989).
The following guidance contains information about:
Basic requirements
All exempt disinfectants must meet all regulatory requirements as outlined above. Before you supply your disinfectant, you should ensure that you have the following information available as it may be requested by the TGA at any point in time:
Formulation
Ingredients included in the formulation of therapeutic goods supplied in Australia must be identified using the relevant Australian Approved Names (AANs).
Australian approved names (AAN)
The TGA develops and maintains approved terminology to ensure accuracy and consistency of the information about goods both on the Australian Register of Therapeutic Goods (ARTG) and exempt from inclusion on the Register.
These approved terms must be used to identify ingredients in your listed disinfectant:
Proprietary ingredients
Proprietary ingredients are entered into the TGA Business System (TBS) by the TGA, using details submitted by the supplier of the ingredient or by a medicine sponsor (on behalf of the supplier) using the Notification of a new proprietary ingredient form. This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number. Sponsors may select proprietary ingredients using the assigned ingredient ID number for use in their application for a listed disinfectant.
Proprietary ingredient formulations are usually fragrances or colouring ingredients and are considered to be 'commercial-in-confidence'.
Microbial efficacy
You will need to adhere to the test requirements as set out in the TGA Instructions for Disinfectant Testing in order to demonstrate microbial efficacy. If requested, you will need to provide all test methodologies and results - a summary will be insufficient. Full test methodologies and results will need to be in English with clear indexing and organisation. A summary of tests and results in English is not acceptable.
Note
Testing as described above may not be applicable to automated airborne disinfectant technologies. These include hydrogen peroxide vapour, hydrogen peroxide + peracetic acid fogging.
Toxicity
Manufacturers must take reasonable steps to ensure the disinfectant product is safe when used as intended, or if there is accidental contact with the product.
There is no expectation that studies will need to be initiated to assemble the necessary data. While a new study might be needed for a new chemical entity, it is expected that this section can be satisfied with information available through a competent search of the available literature and/or databases.
The TGA will accept information generated for other regulatory agencies. It is understood that most available toxicity data will be in relation to the individual components of a formulation rather than the formulation itself.
Toxicity tests on disinfectants used on surfaces should clearly identify any potential hazards of the formulation and risks to the user, through either intended use or accidental body contact. These hazards and risks must be clearly identified on labels and in product information.
Manufacturers should consider the following when determining toxicity of their product:
Additional information should also be supplied for the following, where applicable:
Packaging requirements
The container for a disinfectant must:
Labelling requirements
All exempt disinfectants must have labelling in place that includes the following:
Post-market - ongoing responsibilities
Your disinfectant must continue to meet all regulatory requirements for as long as you continue to supply within Australia.
You will need to retain the following information in case it is requested by the TGA:
Note
Evidence to demonstrate compliance with regulatory requirements must be held by the manufacturer or sponsor for examination on request in the event of a problem arising with the product or as part of a routine compliance evaluation.
Advertising
Advertising for disinfectants (including the label) must comply with all applicable therapeutic goods advertising requirements. These include:
Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | Original publication | Therapeutic Goods Administration | July 2019 |
V1.1 | 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 | Therapeutic Goods Administration | April 2020 |
V1.2 | Changes to reflect the requirement for advertising pre-approval in specified media ending on 30 June 2020 | Therapeutic Goods Administration | July 2020 |
V1.3 | Minor updates | Therapeutic Goods Administration | May 2021 |