TGA has approved it, even handing out licence to GMP facilities for the production of it. However to grow, distribute, manufacture in Australia you have to deal with the office of drug control, which is convoluted at best. The entire supply chain down to the customers has to be established.
I'm curious as to when the GMP licence will be provided for the Slovenian facility. Normally it is about 3 months after the inspection. I would assume that has happened by now.
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