Kippax,
As you are aware the time period placed on the completion of a MAA is 255 normal weekdays, this time has now come and gone - I know someone here blame TGA for the delay but to me this was not the case, the delay imo was all SUDA either not having the information requested by TGA which is hard to understand as all trails have said to be completed - or could it be that they could give answers on the manufacturing safety etc
prescription medicine registration process, page-35
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