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Stoway, The TGA fines were for alleged advertising. Check the...

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Domesticgod

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11/08/21

21:24

Post #: 55216616
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Originally posted by stoway ↑

I admit that a Regulatory Body (TGA) in Australia would be careful about issuing infringement notices. But could someone attempt to resolve some of these queries running in my head?

Therapeutic goods must be entered in the Australian Register of Therapeutic Goods(ARTG) before they can be lawfully supplied in, imported into, or exported from Australia, unless exempt from being entered in the ARTG, or otherwise authorised by the TGA.

My understanding is that Starpharma are not exporting Viraleze, it is manufactured in Belgium. i.e Excerpt: "We have already undertaken substantial launch preparations, including manufacturing in Europe, to ensure VIRALEZE™ is available to consumersPictured above: Manufacture and shipping of VIRALEZE™ in Belgium" .

Further - If Australians cant get their hands on VIRALEZE can they be considered "consumers" - and thus fall within the reach of the TGA?
Then I assume its the ingredient SPL7013 that is the issue. If Starpharma are only exporting the ingredients for VIRALEZE to be manufactured offshore then are they subject to the TGA legislation?

So it isnt manufactured in Australia, or available to consumers in Australia, and its ingredients arent the issue - then is it solely by the logic that Starpharma is an Australian Company that this is a TGA issue.

PS I understand that the MHRA is a completely different matter.

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Stoway,

The TGA fines were for alleged advertising. Check the ASX announcement again

“TGA infringement notices for alleged advertising”

However, I am still not clear why Viraleze cannot be supplied to individuals in Australia and NZ from Viraleze.co in Holland for their personal use.

SPL Price at posting: $1.23 Sentiment: Hold Disclosure: Held
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