My god mattilla I can honestly not believe the waffle and rubbish you're posting!!
Seriously have you done any basic research?
I shouldn't waste my time but for the benefit of the 7 that liked your post and the other uneducated individual that considered it great analysis....Pleeeease!!!
I'll spell it out for the ppl that believe this rubbish.
Invisishield is already available in Australia BECAUSE it's a COSMETIC sanitiser!!
"Hand sanitisers that are excluded from TGA regulation because they are cosmetics
Hand sanitisers, or antibacterial skin preparations, are considered to be 'general consumer products' (cosmetics) and are not regulated by the TGA if:
- they contain only low-risk ingredients (i.e. does not contain a substance included in Schedules 2, 3, 4 or 8 of the Poisons Standard)
- the therapeutic claims about the product are limited to general low level activity against bacteria (for example, kills 99.9% of bacteria).
The
National Industrial Notification and Assessment Scheme (NICNAS) regulates the ingredients in cosmetics and the
Australian Competition and Consumer Commission (ACCC) regulates labelling of cosmetics.
However, if these products make any therapeutic claims beyond being active against bacteria, they are not excluded from regulation by the TGA. The
Therapeutic Goods (Excluded Goods) Determination 2018 (the Excluded Goods Order) sets out the circumstances in which antibacterial skin care products will be regulated as therapeutic goods. These include therapeutic claims made about the products in relation to:
- being active against viruses, fungi or other microbial organisms (other than bacteria)
- for use in connection with disease, disorders or medical conditions
- being for use in a health care setting (this includes aged care facilities)."
This does not make it a "
therapeutic good instantly"
Invisishield is listed as a cosmetic sanitiser that kills 99.99% of germs as it currently stands.
If it claims to kills viruses then it needs to be assessed which requires submission and evaluation before given approval to be a therapeutic goods.
It's not
. buddy!!
Why do you think SKN want to put PathAway in their product in the first place??
Because it's a basic cosmetic hand sanitiser that doesn't meet or require TGA approval for that very reason
"Hand sanitisers regulated as therapeutic goods
Antibacterial hand hygiene products that require evaluation from the TGA and inclusion in the Australian Register of Therapeutic Goods (ARTG) are those that meet one or both of the following criteria:
- products that are claimed to kill specific organisms (e.g. E. coli or viruses)
- are to be used in clinics or hospitals."
If you're going to claim it on the ARTG and market and sell it as a covid 19 killer ou need approval from the TGA.
"
My guess is the holdup is seeking approval and registration with the TGA"
These are your words so be very careful what you wish for.
Last I checked the time given to be TGA approved as an OTC sanitiser is 55-70 days.
That's a long long time to be suspended.
If you doubt me then ring the TGA on 1800 020 653 and ask for Christina.
Ask her yourself.
You're lucky though because anything covid 19 related gets put to the front of the queue so you might find yourself suspended for only a month.
I urge all holders to do some basic research and DYOR not listen to rubbish and made up theories here on HC on what you have and currently hope to have and the process involved to obtain it.
I'll make it easy for you, here's a start...
https://www.tga.gov.au/hand-sanitisers-information-manufacturers-suppliers-and-advertisers
(20min delay)