What TGA requirements need to be met to produce sanitiser for hospitals?
The Therapeutic Goods Administration (TGA) has made a new legislative instrument that allows local production of hand sanitiser to be carried out more readily.
This includes sanitisers for healthcare facility use – including hospitals and 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 qualities than medical grade alcohol can be used in the manufacture of the hand sanitisers.
I would like to supply medical equipment to the Government
SA Health has existing contractual arrangements in place that will meet increased demand for 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 be able to provide the following first stage information: product specifications, volume, price, timeline for delivery, country of origin, proof of certification with traceability to the certifier.
How can my business manufacture PPE?
All South Australian companies with an interest in manufacturing PPE items should register their details via this Austender RFI portal
The Commonwealth Government is currently mapping domestic production capability of medical personal protective equipment (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.
How do I get PPE for my business?
You can register your shortage on the national Industry Capability Network (ICN) portal
that is being 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.
My company can provide technical and clinical solutions to COVID-19, who should I contact?
If your company can provide technical or clinical solutions, such as test kits and medical equipment. Please contact the Department for Trade and Investment: DTI.Reception@sa.gov.au