From SUD Announcement dated 3 April 2016 - as I have stated before is the fact that they stated 255 days without any clarifications that the 255 days were in fact what we consider working days or something else:
In late 2016, SUDA made a pre-submission to the TGA and based on that filing the TGA has advised that the filing is complete and deemed the MAA submission to be effective and has accepted the dossier for evaluation. The TGA now has 255 days to complete its review and provide an opinion, including potential approval of the ArTiMist Marketing Authorisation.
prescription medicine registration process, page-36
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