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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Action
- Medical device cancellation (851)
- Medicine suspension (506)
- Complementary medicine cancellation (205)
- Medical device suspension (88)
- Medicine cancellation (59)
- Revocation of a TGA issued Conformity Assessment Certificate (55)
- Voluntary revocation at the request of the manufacturer (39)
- Medical device cancellation - certain devices within an entry (23)
- Registered medicine cancellation (14)
- Medical device cancellation - requested by the sponsor - certain devices within an entry (8)
- Medical device cancellation (7)
- Listed medicine cancellation (4)
- Listed medicine cancellation (4)
- Revocation of a TGA issued Conformity Assessment Certificate. (3)
- Revocation of medical device suspension (3)
- Revoked medicine suspension (2)
- AFT Pharmaceuticals Pty Ltd (1)
- Alphapharm Pty Ltd (1)
- Complementary Medicine Cancellation (1)
- Complementary medicine cancellation (1)
- Medical device cancellation (1)
- Suspension from the ARTG under subsection s41GA(1)(b) (1)
- Voluntary revocation at the request of the manufacturer. (1)
Find out more about Cancellations and Suspensions.
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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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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 11/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 07/11/2020
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Cancellation or suspensionRegulatory action due to The product is not a therapeutic good/medical device therefore the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect., effective 06/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 06/11/2020
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Cancellation or suspensionRegulatory action due to Medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia, effective 06/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 06/11/2020
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Cancellation or suspensionRegulatory action due to Medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia, effective 06/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 06/11/2020
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Cancellation or suspensionRegulatory action due to Non response to a s41JA, effective 06/11/2020
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Cancellation or suspensionRegulatory action due to The product is not a therapeutic good/medical device therefore the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect., effective 06/11/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a notice under section 41JA of the Act and therefore failed to comply with an automatic condition of inclusion under s41FN(3)(c)of the Act., effective 04/11/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to provide information requested by the TGA under section 41JA of the Act. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(c) of the Act)., effective 03/11/2020