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Increased flexibility for production of hand sanitiser to bolster supplies

30 March 2020

Joint media release with the Minister for Health the Hon Greg Hunt MP

The Australian Government Therapeutic Goods Administration (TGA) has cut the red tape on the manufacturing of hand sanitiser, whilst maintaining strict safety requirements, to bolster supply in Australia.

Currently, there is high demand for hand sanitiser in Australia’s health care system and hospital networks – particularly in rural and regional parts of the country.

The TGA has introduced an urgent legislative instrument and guidance to make it easier for local businesses to manufacture hand sanitiser.

This includes sanitisers for use in health care facilities – such as hospitals, aged care and other residential facilities – as well as for general consumer use.

Production of hand sanitiser can now proceed without the requirement of TGA approval or notification, provided one of the two recipes developed by the World Health Organization and endorsed by the US Food and Drug Administration are used.

Furthermore, if these recipes are used, food grade alcohol, which is cheaper and available in larger qualities than medical grade alcohol, can be used to manufacture the hand sanitisers.

Strict safety requirements have been placed on the labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions, and maintain records of production to maintain consumer safety.

Companies wishing to manufacture or import new high-end hand sanitisers with different recipes for use in health care facilities will still require TGA approval. But as per other products related to the COVID 19 pandemic, the TGA will prioritise these applications and review them as quickly as possible.

These changes will make it easier for Australian businesses to produce and supply hand sanitiser to meet rising demand caused by the COVID-19 outbreak.

The TGA’s actions will not only ease supply pressures, it will also provide opportunities for Australian businesses.

Wineries and grape-growers affected by smoke damage caused by the recent bushfires, and boutique distilleries that have lost passing tourist trade, are turning to manufacturing alcohol, the key ingredient in sanitisers.

These changes follow a roundtable between Minister Andrews, the TGA and key players in the hand sanitiser supply chain last week. A follow up will be held this week.

Further information is available by ringing 1800 020 653, emailing otc.medicines [at] health.gov.au, or from the TGA website.

Media contacts:

Minister Andrews' office 02 6277 7070

Minister Hunt's office 02 6277 7220