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 (87)
- Medicine cancellation (59)
- Revocation of a TGA issued Conformity Assessment Certificate (55)
- Medical device cancellation - certain devices within an entry (23)
- Voluntary revocation at the request of the manufacturer (18)
- 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 The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA, effective 12/07/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA letter., effective 02/07/2019
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Cancellation or suspensionRegulatory action due to Information supplied to the TGA was insufficient to substantial compliance with Conformity Assessment procedures (s.41FN 3(a)) and the Essential Principles (s.41FN3(b)). Additionally, the sponsor did not comply with conditions of inclusion (s.41FN 3(c)) and false or misleading information was provided at the time of application (s.41FD (d))., effective 05/06/2019
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Cancellation or suspensionRegulatory action due to The Secretary was satisfied that a statement made in, or in connection with, the application for listing of the product was false or misleading in a material particular. It appeared to the Secretary that a certification made by the sponsor under paragraph 26A(2)(ja) of the Act was incorrect., effective 03/06/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular., effective 17/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular., effective 17/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular., effective 16/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular., effective 16/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular., effective 16/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with the notice under section 41JA requiring to provide information and to demonstrate that all matters certified under section 41FD of the Therapeutic Goods Act 1989 were correct, in a material particular., effective 15/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA letter, effective 03/05/2019
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Cancellation or suspensionRegulatory action due to The sponsor did not provide information or documents when required under a section 41JA notice., effective 29/04/2019
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Cancellation or suspensionRegulatory action due to The sponsor did not provide information or documents when required under a section 41JA notice., effective 29/04/2019
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 10/04/2019
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of inclusion in that the sponsor failed to provide information to the Secretary as required in response to a section 41JA letter., effective 27/02/2019
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Cancellation or suspensionRegulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certificates., effective 20/02/2019
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Cancellation or suspensionRegulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certificates., effective 20/02/2019
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 06/02/2019
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 10/01/2019
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 26/11/2018
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 04/10/2018
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 22/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018
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Cancellation or suspensionRegulatory action due to Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 11/08/2018