Withdrawal of TGA submissions. - Medical Devices Group

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

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Posted by Ayhan Aydin

Asked on October 19, 2016 12:00 am

217 views

like 4 comments

	Private answer Ask Arthur Brandwood. Marked as spam like Report spam
	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. Marked as spam like Report spam
	Private answer Kavita Sharma Followed by section 41JA and to submit the audit review documentation Marked as spam like Report spam
	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 Marked as spam like Report spam

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