Due to the COVID-19 pandemic, there has been significant interest from potential sponsors and manufacturers in producing and selling disinfectants and other related products to the Australian market. There is specific interest on whether claims made to remove, kill, or reduce viruses (such as the virus that causes COVID-19) are permitted under therapeutic goods legislation.

Because of this, the TGA (Therapeutic Goods Administration) has recently released a guidance document intended to assist sponsors and manufacturers to understand the regulation of these products.

Disinfectants are regulated depending on the intended purpose and claims made in relation to that purpose. There are three key categories of disinfectants:

  1. Other Therapeutic Good – Listed disinfectants

Listed disinfectants are disinfectant liquids, sprays, wipes, sponges and aerosols that make specific claims that a product kills, or is active against, viruses, spores, tuberculosis, mycobacteria or fungi and that:

  • are intended for use on inanimate objects such as hard and soft surfaces (for example floors, walls, door handles, bench tops, curtains, lounge furniture and carpets)
  • are not intended for use internally or on skin
  • are not intended for use on medical devices

These products are required to be Listed in the Australian Register of Therapeutic Goods (ARTG) before they are supplied to the market and must meet all regulatory requirements as set out in the relevant legislation and guidance, including, Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019, and the Therapeutic Goods Advertising Code (No. 2), 2018.

  1. Other Therapeutic Good (OTG) – Exempt disinfectants

Exempt disinfectants are liquids, sprays, wipes, sponges and aerosols that are intended to kill microorganisms but do not make claims that the product kills, or is active against, viruses, spores, tuberculosis, mycobacteria or fungi.

Exempt disinfectants are not required to be listed on the ARTG but must still comply with other regulatory requirements, including, compliance with TGO 104 and the Therapeutic Goods Advertising Code (No. 2), 2018.

  1. Medical Device Disinfectants

Disinfecting and cleaning liquids, sprays, wipes and aerosols that are intended to be used on medical devices are regulated as medical devices and are required to be entered on the ARTG before sale in Australia. The Classification of these medical devices depends on the intended purpose and claims made in relation to cleaning or disinfecting medical devices.

The key takeaways are:

  1. Making generic claims and not making specific claims relating to viruses, spores, tuberculosis, mycobacteria, or fungi are exempt from the requirement to be included on the ARTG. For example, claiming your disinfectant kills 99.9% of germs will not require it to be listed on the ARTG but claiming your disinfectant kills the virus that causes COVID-19 will require listing on the ARTG.
  2. Specific claims include claims to kill or reduce the COVID-19 virus, or to provide residual

protection from the COVID-19 virus.

  1. Any disinfectant or related product that is intended to be used on medical devices is regulated as a medical device and must be included in the ARTG as a medical device.

Note the above information is only applicable to Disinfectants. If the product is intended for use internally (inside a human being) or intended for use on human skin, it does not meet the definition of a disinfectant and will be regulated separately.