prescription medicine registration process, page-2

Hi All

Well here we are, hopefully past Milestone 3 and moving through Milestone 4. If my interpretation of the dates is correct then by 31st July SUDA will have received a request from the TGA for further information following their evaluation of the marketing submission for ArTiMist that commenced 1st April 2017.
Milestone 4 gives SUDA a max of 30days to respond to queries raised and to review the first round assessment reports for factual content. This period will end 31st August (or sooner)

This leads into Milestone 5 that gives the TGA up to 30days to review responses from SUDA.
which ends 30th September at the latest, with SUDA being advised of the result mid Nov 2017 (at the latest).

Exciting and nervous months ahead. Remember this process has a pre-determined timeline that is driven by others not SUDA.

kippax