The TGA has made a new legislative instrument that allows local production of hand santiser to be carried out more readily.
This includes sanitisers for healthcare facility use - including hospitals, aged care and other residential facilities – as well as for general consumer use.
Small and large-scale production of hand sanitiser can now proceed without requirement for TGA approval or notification provided that only one of two recipes developed by the World Health Organisation (WHO) and endorsed by the US Food and Drug Administration (FDA) are used.
If these recipes are used, food grade alcohol, which is cheaper and available in larger quantities than medical grade alcohol, can be used in the manufacture of hand sanitisers.
SA Health has existing contractual arrangements in place that will meet increased demand for personal protective equipment (PPE) items.
However, you can register your capabilities on the national Industry Capability Network (ICN) portal which is being used to connect those organisations experiencing PPE shortages with suppliers.
All South Australian companies with an interest in importing PPE items from overseas for potential on-selling to SA Health or other health authorities must provide the following first stage information: product specifications, volume, price, timeline for delivery, country of origin and proof of certification with traceability to the certifier.
All South Australian companies interested in manufacturing PPE items should register their details via this Austender RFI portal.
The Commonwealth Government is currently mapping domestic production capability of medical PPE, including: surgical gowns, gloves, goggles, hand sanitisers, clinical waste bags, waste bag closure devices (ties), blood and fluid spill kits, mask fit test kits and thermometers.
Responses will be used to inform national activities and be shared with state authorities.
Register your shortage on the national Industry Capability Network portal used to connect organisations experiencing PPE shortages with suppliers.
Once registered, an ICN consultant will be in touch to discuss your needs in more detail and can conduct investigations across the national network.
Advice from the Australian Taxation Office (ATO) on the production of hand sanitiser is that it does not ordinarily attract excise as its alcohol content has usually been treated (denatured) to make it unfit for human consumption.
Regulatory requirements apply to the production and use of concessional spirits. For example, businesses need to apply for ATO permits to purchase (undenatured) spirit from licensed manufacturers for use in the commercial production of hand sanitiser.
Denatured spirit may also be suitable for making hand sanitisation and other commercial cleaning products and can be purchased without restriction.
The ATO will support further production of hand sanitiser during these difficult times for existing concessional spirit permit holders, licensed distillers, and other licensed entities. Visit the ATO website or email Alcohol@ato.gov.au
Phone 1300 137 290 between 8.00am and 6.00pm, Monday to Friday.