Ayhan Aydin
Account Manager at The Janssen Pharmaceutical Companies of Johnson & Johnson
October 2016
< 1 min reading time
Any advice would be muchly appreciated. How many times are you able to get an extension on the decision regarding TGA submission withdrawals? If you do withdraw your submission, then work to meet the failing criteria, does this mean you will start the process of TGA submission from the start again? source: https://www.linkedin.com/groups/78665/78665-6194544364404961280 Marked as spam
 Posted by Asked on October 19, 2016 8:00 am
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Private answer
Arthur Brandwood
I am assuming that you are talking about a Conformity Assessment and not a Cc supported registration. Generally withdrawal is just that, you need to start over. TGA are pretty reasonable in allowing applicants to fix deficiencies- up to a point. They like to get it all sorted before commencing the assessment stage. That way if you do withdraw you only lose the application fee and not the full assessment fee.
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Private answer
Kavita Sharma
Followed by section 41JA and to submit the audit review documentation
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Private answer
Kavita Sharma
Hi Ayahan, if you decide to withdraw the application , that means tga will not review that application. The payment won't be refunded. If you are referring to 'application push back' that is different . In this situation the assessor will allow a pushback. Firstly to review the classification
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