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 good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 18/06/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 18/06/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 18/06/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 8(f) of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 18/06/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to provide information requested under section 41JA of the Act and therefore failed to comply with an automatic condition of inclusion under section 41FN(3)(c) of the Act., effective 16/06/2020
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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 01/06/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 14 of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 26/05/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 14 of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 26/05/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 14 of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 26/05/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 14 of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 26/05/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 14 of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 26/05/2020
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Cancellation or suspensionRegulatory action due to The good had become an exempt good under Schedule 5, Item 14 of the Regulations. Exempt goods are not required to be included on the ARTG (paragraph 18(1) of the Act)., effective 26/05/2020
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Cancellation or suspensionRegulatory action due to The Device was suspended from the Register under section 41GA of the Act, and the period of suspension, applied under subsection 41GC(3) has expired before the suspension was revoked under section 41GD of the Act.The information submitted in response to the suspension is insufficient to remove the grounds for cancellation and fulfil the requirements of the suspension being revoked., effective 20/04/2020
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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 14/04/2020
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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 01/04/2020
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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 27/03/2020
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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 27/03/2020
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Cancellation or suspensionRegulatory action due to Voluntary revocation at the request of the manufacturer., effective 13/03/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to provide evidence to demonstrate that the medical device complies with the applicable provisions of the Essential Principles. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(a) of the Act)., effective 24/02/2020
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Cancellation or suspensionRegulatory action due to The sponsor failed to provide evidence to demonstrate that the medical device complies with the applicable provisions of the Essential Principles. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(a) of the Act)., effective 19/02/2020
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Light therapy unit infrared [35147] (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Cancellation or suspensionRegulatory action due to The sponsor failed to provide evidence to demonstrate that the medical device complies with the applicable provisions of the Essential Principles. The sponsor therefore failed to comply with an automatic condition of inclusion (s41FN(3)(a) of the Act)., effective 18/02/2020 -
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 14/02/2020
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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 14/02/2020
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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 14/02/2020
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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 12/02/2020