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  • 1.  TGA Australia - Change in Sponsor Address

    Posted 08-Feb-2017 15:50
    Hi,

    I have few questions regarding changing the sponsor office address in Australia.

    The office address are on all the medical devices Labels, user instructions, cartons, promotional materials, etc.

    After the office move there are no time to implement the change immediately. So I am assessing the impact of the change now.

    1. What is the impact from TGA regarding the products that still have the old address?
    (ex: fine the company, revoke license, stop selling the product, etc)
    2. can the UI and labels be updated first then the carton? that means that the user will receive package with 2 diff office address.
    what is the impact?
    3. If the PO of the old address can still be active for couple of months, would this be enough till the change is fully implemented?
    4. I can't see this change having any impact on Declaration of Conformity and licenses?

    Many Thanks
    Masar

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    Masar
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  • 2.  RE: TGA Australia - Change in Sponsor Address

    Posted 09-Feb-2017 03:53
    Hi Masar - Usually for a change in Sponsor (including name and address), you can notify TGA and update the address in TBS within 3 months. Then in about 10days, TGA will update the ARTG certificates with the new sponsor name and address. In your case, if it is just address change of sponsor, then I guess it is the same - update TBS with in 3 months and make sure that you update product labeling with new address within this 3 months. If not sure, you can write an e-mail to TGA, you may get a response within a week or less. 

    Regards,
    Sreenu

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    Sreenu. S
    Singapore
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    Original Message


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