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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432 result(s) found, displaying 26 to 50
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Cancellation or suspensionRegulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 17/12/2020
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Cancellation or suspensionRegulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 17/12/2020
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Cancellation or suspensionRegulatory action due to The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect., effective 09/12/2020
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Cancellation or suspensionRegulatory action due to The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect., effective 09/12/2020
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Cancellation or suspensionRegulatory action due to The product is not a medical device. Therefore, the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect, effective 09/12/2020
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Cancellation or suspensionRegulatory action due to The device was incorrectly classified as a class I medical device. From the information available the device should be included on the ARTG at a higher classification. Therefore, the certification made by the sponsor under paragraph 41FD(c) of the Act in the application for inclusion is incorrect., effective 08/12/2020
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Cancellation or suspensionRegulatory action due to Failure to comply with a condition of inclusion, effective 07/12/2020
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Cancellation or suspensionRegulatory action due to Non response following a s41JA, effective 03/12/2020
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Cancellation or suspensionRegulatory action due to Non response following a s41JA, effective 03/12/2020
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Cancellation or suspensionRegulatory action due to Non response following a s41JA, effective 03/12/2020
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Cancellation or suspensionRegulatory action due to Non response following a s41JA, effective 03/12/2020
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Cancellation or suspensionRegulatory action due to Non response following a s41JA, effective 03/12/2020
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Cancellation or suspensionRegulatory action due to Non response following a s41JA, effective 03/12/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to demonstrate that the Device complies with Essential Principles 1,3,6,13, 14 and 15., effective 02/12/2020
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 01/12/2020
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Cancellation or suspensionRegulatory action due to The Sponsor failed to comply with the notice under section 41JA within a further 10 working days., effective 26/11/2020
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Cancellation or suspensionRegulatory action due to The product is not a medical device therefore the certifications made under section 41FD of the Act at the time of application are incorrect., effective 25/11/2020
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Cancellation or suspensionRegulatory action due to Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b) & (1)(e)., effective 24/11/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to respond to a request for information and therefore failed to comply with an automatic condition of inclusion., effective 23/11/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to respond to a request for information and therefore failed to comply with an automatic condition of inclusion., effective 23/11/2020
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Cancellation or suspensionRegulatory action due to Failure to comply with a condition of inclusion, effective 20/11/2020
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Cancellation or suspensionRegulatory action due to The sponsor has failed to comply with an automatic condition of inclusion applied to this ARTG entry under subsection 41FN(5A) of Therapeutic Goods Act 1989 and regulation 5.11 of Therapeutic Goods (Medical Devices) Regulations 2002, to provide information about the safety and performance of the Devices by 1 October each year for three consecutive years after the inclusion., effective 20/11/2020
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Cancellation or suspensionRegulatory action due to The product is not a medical device therefore the certification made by the sponsor under paragraph 41FD(a) of the Act, that the Product in question is a medical device, is incorrect., effective 16/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 12/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 12/11/2020
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