Ann: TGA Registration Update, page-264

You seem pretty confused. TGA doesn't make the application, they make the rules. TGA also advises in the link you provided to contact a regulatory affairs consultant if you want the application to sail through without queries.

TGA has come back to AnteoTech with questions that were foreseeable. Does nobody know how to deliver a project!

Do you think these queries were not foreseeable? That the company did a smashing job in the regulatory application?

This is about as good as the original UK application where the sampling technique was not defined.