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  • 1.  Australian Sponsor

    This message was posted by a user wishing to remain anonymous
    Posted 04-Nov-2019 15:17
    This message was posted by a user wishing to remain anonymous

    Hi,

    A device is registered in Australia through an Australian sponsor. The device was never sold in Australia. We want to terminate the Australian sponsor services as the device sales still looks dormant.

    My question is do we need to notify TGA that the Australian sponsor services are terminated? Is there anything else which should be taken into consideration before we terminate the AR services?
      
    Device approval still remains active if we do not have a sponsor?

    Thanks for any insights!


  • 2.  RE: Australian Sponsor

    Posted 04-Nov-2019 16:58
    Hi,

    The ARTG entry also needs to be cancelled , this will have to be done by your Australian sponsor.​

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    RashmiGreenacresAustralia
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    Original Message


  • 3.  RE: Australian Sponsor

    Posted 05-Nov-2019 03:43
    Dear Anonymous,
    One of the conditions of inclusion on the ARTG is the designation of an Australian Sponsor. So if you do decide to terminate your current Sponsor and you want to continue supplying in Australia, then you will need to assign a new Sponsor. There are many reputable organizations in Australia who can provide this service and I would be happy to recommend a couple offline.

    Whatever course you take with respect to terminating or transferring Sponsor responsibilities, you will need to notify the TGA. There is a guidance document available on their website (Changing the sponsor of therapeutic goods) that will point you in the right direction.

    If you decide that you do not want to appoint a new Sponsor, then you will be required to withdraw any ARTG entries that your Sponsor holds for your products. Again, the TGA has a guidance document that can help you with that too.

    I hope this addresses your concerns.

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    Elizabeth Freitas, PhD
    Assoc Director, Regulatory Affairs
    Illumina Australia Pty Ltd

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    Original Message


  • 4.  RE: Australian Sponsor

    Posted 06-Nov-2019 08:01
    Perhaps I can add a couple of points to the excellent advice from Elizabeth..

    The smoothest route is to persuade your existing sponsor to consent to transfer the sponsorship to a new entity.  This then is an administrative process sing the forms indicated by Elizabeth and comes with a small TGA fee attached.  however, depending on the nature of the device and the commercial considerations the existing sponsor may or may not agree, or may demand a fee for doing so (I have seen cases where very large fees were extracted for transfer of valuable high risk device registrations).

    If the existing sponsor won't agree, then:

    1. You will need to get the new sponsor to arrange a new registration.  Depending on the risk class this may involve a new regulatory review.  If the device is Class I there is really minimal impact because the registration is in effect a notification with no review.
    2. There is no need in this case to take any action regarding the old registration.  TGA allows multiple registrations for the same device via different sponsors.  The old sponsor will not be able to supply because you will not be providing them product (unless they have residual stock).  The old sponsor will bear the cost of annual fees - so it is in their interest to cancel.

    Now more generally, an option is to use a third party to hold the registration.  This allows you to select and change your distributors on commercial terms without need to change the sponsorship or registrations.  The right choice of service provider can mean that yo have a higher level of local regulatory expertise than is available within many distributors (who often subcontract this anyway).  We do this for many international clients and put in place arrangements acceptable to TGA for working with both the manufacturer and the local distributor(s) to ensure both pre- and post-market compliance.  Feel free to message me offline if you would like to discuss in more detail.

    Regards

    Arthur  


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    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
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    Original Message


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