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 It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 05/06/2017
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Cancellation or suspensionRegulatory action due to Under subsection 41GA(1)(b); it is likely there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 02/06/2017
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods., effective 30/05/2017
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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 26/05/2017
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Cancellation or suspensionRegulatory action due to , effective 18/05/2017
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IntelliVue MX40 (Suspension from ARTG for a 6 month period under paragraph 41GA(1)(a)(i) of the Act)
Cancellation or suspensionRegulatory action due to 6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious illness or serious injury if the kind of device continues to be included in the ARTG., effective 16/05/2017 -
Cancellation or suspensionRegulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection GN(1)(b)., effective 21/04/2017
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods., effective 21/03/2017
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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 21/03/2017
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Cancellation or suspensionRegulatory action due to As the sponsor did not comply with a product specific condition of registration for the Therapeutic Goods in the ARTG and the failure to provide information required under a s.31 letter., effective 07/03/2017
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Cancellation or suspensionRegulatory action due to As the sponsor did not comply with a product specific condition of registration for the Therapeutic Goods in the ARTG and the failure to provide information required under a s.31 letter., effective 07/03/2017
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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 03/03/2017
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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 03/03/2017
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods., effective 06/02/2017
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of listing imposed by the Secretary under s.28(2B) of the Act., effective 01/02/2017
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of listing imposed by the Secretary under s.28(2B) of the Act., effective 01/02/2017
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of listing imposed by the Secretary under s.28(2B) of the Act., effective 01/02/2017
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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 11/01/2017
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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 11/01/2017
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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 11/01/2017
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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