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Hi Community,
I would like your support with following question:
We are interestered in exporting a cannabis formulation through the SAS (Special Access Scheme) pathway (*). It is our interpretation that NO GMP Clearance from TGA is needed under this way (SAS), since the product is consider "unapproved". Is this correct? Or a GMP Clearance is needed when the SAS is used?
Any further thoughts on this?
Thanks.
(*) https://www.tga.gov.au/form/special-access-scheme