26 September 2023

TGA cleans up sanitiser approval

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The Therapeutic Goods Administration (TGA) is to cut red tape on the manufacture of hand sanitiser in a bid to bolster supplies of the disinfectant in Australia.

Minister for Health, Greg Hunt said there was currently high demand for hand sanitiser in the health care system and hospital networks, particularly in rural and regional parts of Australia.

“The TGA has introduced an urgent legislative instrument and guidance to make it easier for local businesses to manufacture hand sanitiser,” Mr Hunt said.

“This includes sanitisers for use in health care facilities … as well as for general consumer use.”

He said production of hand sanitiser could now proceed without the requirement of TGA approval or notification, provided one of the two recipes developed by the World Health Organisation and endorsed by the US Food and Drug Administration were used.

“Furthermore, if these recipes are used, food grade alcohol, which is cheaper and available in larger quantities than medical grade alcohol, can be used to manufacture the hand sanitisers,” Mr Hunt said.

He said that strict safety requirements had been placed on the labelling of such products however.

“Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain records of production to maintain consumer safety,” Mr Hunt said.

He said the changes would make it easier for Australian businesses to produce and supply sanitiser to meet rising demand during the pandemic.

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

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