Hand sanitiser – What do you need to know to supply in Australia?

^{Posted on April 1, 2020}

The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories have been impacted even day to day.

One of the areas with significant change is hand sanitisers; while washing hands with soap is still considered to be the most effective way to practice good hand hygiene, hand sanitisers can play an important role in keeping hands as free from harmful microorganisms as possible.

Shortages of hand sanitisers are here already, and the inventive, creative and sometimes concerning ways to overcome these potential shortages can pose a risk to the community.

Traditionally, hand sanitizers have been regulated as either ‘cosmetics’ or ‘therapeutic goods’, based on the types of claims made and the ingredients used.

To ease the burden of these shortages, from the 28^th of March this year the Therapeutic Goods Administration (TGA) has introduced an additional category. Two formulations that were previously regulated as ‘therapeutic goods’ are now excluded from the TGA process requirements for the duration of the COVID-19 pandemic. This was enacted through the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020. It should be clear however that although certain hand sanitisers do not need to be lodged to the TGA, there are still specific requirements in the Determination that must be met before the product can be supplied through this route.

For anyone looking to import or produce hand sanitisers locally it is very important to be aware of the requirements to ensure your product is compliant for supply within Australia. The COVID-19 specific measures implemented by the TGA are creating an ever-evolving complex regulatory environment.