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 The goods have changed so they have become separate and distinct from the goods included in the ARTG.As the presentation of the product was unacceptable, the certification made under s.26A(2)(c) was incorrect.The sponsor failed to comply with a condition of listing under s.28(5)(ab) (that the goods would not be advertised for an indication other than those accepted in the Register).The goods do not conform to a standard applicable to the goods., effective 11/07/2014
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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 19/06/2014
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Cancellation or suspensionRegulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014
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Cancellation or suspensionRegulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014
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Cancellation or suspensionRegulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014
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Cancellation or suspensionRegulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014
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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 by the applicant under s26A(2)(j) was incorrect., effective 16/05/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 30/04/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 30/04/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under s.41JA requiring further information about the kind of medical device., effective 10/03/2014
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Cancellation or suspensionRegulatory action due to The goods did not conform to a standard applicable to the goods as the label did not comply with the Therapeutic Goods Order No. 69 (TGO 69)., effective 06/03/2014
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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).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014
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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).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014
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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 03/02/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 31/01/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 31/01/2014