The outbreak of COVID-19 has led to a marked increase in the demand and production of hand sanitisers in Australia.
In order to ease supply pressures, the TGA relaxed regulations on the manufacture of medical grade hand sanitisers at the end of March, making it easier for local businesses to manufacture hand sanitiser.
Under the new legislation, production of hand sanitiser can now proceed without TGA approval or notification, as long as it uses the formulations developed by the World Health Organisation (WHO).
These therapeutic hand sanitisers are regulated by the TGA and must follow the formulations dictated by WHO, which will contain 80% ethanol or 75% isopropyl alcohol.
Companies that manufacture or import hand sanitisers made with different formulations for use in health care facilities will still require TGA approval.
Though TGA approval and notification is not required, manufacturers of therapeutic hand sanitiser must still maintain safety standards, said TGA.
For instance, manufacturers that use purified water that is produced by purification processes other than boiling or distillation must undergo regular microbiological testing.
They must also verify the concentration of ethanol by testing samples of each batch using methods such as gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of “equivalent or greater accuracy”.
Promotional limits
Hand sanitisers that have been exempted from TGA registration are limited in terms of promotional material to business logos and required label information.
They must also include statements noting the use of a WHO formulation and that it is suitable for use in medical and health services.
TGA noted that an advertisement for hand sanitiser of any kind cannot make claims that the product can ‘kill’ COVID-19 or imply that it can prevent or treat COVID-19.
“The label or an ad for a hand sanitiser cannot claim to help reduce the transmission of the coronavirus or prevent COVID-19 unless it has been approved for those claims,” said TGA.
Failure to comply with this rule will void the exemption of the product and it will be subject to the therapeutic goods requirements, including the need for it to be included in the Australian Register of Therapeutic Goods (ARTG).
If a hand sanitiser claims to kill specific organisms such as E.coli or viruses, it is required to be assessed and regulated by the TGA for safety, quality and effectiveness.
Hand sanitisers that have undergone TGA regulation will have an AUST R number included on the label.
TGA warned consumers: “If a hand sanitiser makes these claims and it does not have an AUST R number on the label, it is likely to be an illegal product that has not been assessed by the TGA.”
The advertising of therapeutic goods must also comply with all other applicable requirements in the Therapeutic Goods Act and the Therapeutic Goods Advertising Code.