TGA document for supplying home-tests
https://www.tga.gov.au/sites/default/files/checklist-for-application-covid-19-rapid-antigen-self-test.docxHad a really brief look. I don't imagine that this is too different from what is required to apply for inclusion into the ARTG in the first place.
Really? 30 tests within 6 months... for delta...? So strict
, such a large sample dataset!
Within 6 months of inclusion in the ARTG, the sponsor must provide a supplemental clinical study to the TGA, which shows the outcome of testing at least 30 clinical samples collected from individuals that are SARS-CoV-2 positive by RT-PCR for the delta variant.
Not only is that outdated, but the time given and the number of samples are extremely inadequate.
They are now also permitting individuals to import tests for personal use. Hopefully word of this doesn't get around or there's going to be a flood of unapproved tests (and approved junk ones) making the rounds, and probably being resold by profiteers.
