Cancellations and suspensions
This database records details of medicines and medical devices that have been cancelled or suspended, and no longer appear in the ARTG.
Following a review by the TGA, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. These cancellations are made by the Secretary under section 30 of the Therapeutic Goods Act 1989.
Where other actions are taken in relation to safety, a link to the TGA's safety alert will be included in the database under 'Further information'.
The reasons for a cancellation are stated in the database below under 'Grounds for cancellation'.
The heading 'Decision status' provides updated information about cancellation decisions, for example information about any decision to revoke a cancellation decision. It will not appear in every entry.
To find out whether a product is currently authorised for supply in Australia, check the ARTG.
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Cancellation or suspensionRegulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 19/12/2016
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 07/12/2016
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Cancellation or suspensionRegulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG., effective 07/12/2016
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Cancellation or suspensionRegulatory action due to As the sponsor did not provide sufficient information to substantiate that the appropriate conformity assessment procedures have been applied to the kind of device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the inclusion of the device in the ARTG were correct, in a material particular., effective 18/11/2016
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 15/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016
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Cancellation or suspensionRegulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016