3 years is the maxium (14.3.1 TGA ) required by law by the TGA any extension of that requires data for stability (14.3.2) !
and assay results to be submitted.
. Also see (14.4) TGA stability biological medicines . Everything has to also comply with GMP. (good manufacturing process)
You need to supply some details of how you get your info please so i can validate your statements ?
Note ! im only answering your statements on the shelf life not your ideas on how they or you should run the company .
Or your investment advice !
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