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 within the required timeframe with a notice under s.41JA requiring further information about the kind of medical device., effective 10/03/2014
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Cancellation or suspensionRegulatory action due to The goods did not conform to a standard applicable to the goods as the label did not comply with the Therapeutic Goods Order No. 69 (TGO 69)., effective 06/03/2014
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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).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014
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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).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014
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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 03/02/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 31/01/2014
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 31/01/2014
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Cancellation or suspensionRegulatory action due to The manufactured medicine is separate and distinct from the medicine included in the ARTG. As the presentation of the product was unacceptable, the certification made under s26A(2)(c) was incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act and did not conform to a standard applicable to the goods., effective 23/12/2013
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act., effective 18/11/2013
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act., effective 18/11/2013
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Cancellation or suspensionRegulatory action due to As the sponsor of the kind of medical device failed to comply with the notice under s.41JA of the Act, requesting the sponsor to give the TGA information relating to the kind of device, within a further 10 working days from the day specified in the notice, the entry was cancelled., effective 01/10/2013
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Cancellation or suspensionRegulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect.As the sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s. 41FO.As the information supplied with the device did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD(f) was incorrect., effective 30/09/2013
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product, the medicine was not safe for the purposes for which it is to be used and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(b), (c) and (j) were incorrect. The goods were also not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the TGAC (see item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations)., effective 27/09/2013
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Cancellation or suspensionRegulatory action due to As the device labelling did not comply with the essential principles, the certification made under s.41FD (d) was incorrect.As the sponsor failed to provide evidence that conformity assessment procedure has been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect.As the promotional material did not comply with the Therapeutic Goods Advertising Code 2007, the certification made under s.41FD(h) was incorrect., effective 24/09/2013
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Cancellation or suspensionRegulatory action due to As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD(f) was incorrect., effective 23/09/2013
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Cancellation or suspensionRegulatory action due to As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD (f) and (g) were incorrect., effective 20/09/2013
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Cancellation or suspensionRegulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect.As the device labelling did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.As the sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s.41FO.As the sponsor failed to supply evidence that conformity assessment procedures have been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect., effective 13/09/2013
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Cancellation or suspensionRegulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect., effective 12/09/2013
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Cancellation or suspensionRegulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect., effective 31/08/2013
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect., effective 16/08/2013
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Cancellation or suspensionRegulatory action due to As the kind of medical device included in the Register was not correctly classified and the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certifications made under s.41FD(c) and (f) were incorrect., effective 05/08/2013
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Cancellation or suspensionRegulatory action due to As the kind of medical device included in the Register was not correctly classified, the certification made by the applicant under s.41FD(c) was incorrect., effective 12/07/2013
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Cancellation or suspensionRegulatory action due to As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act., effective 05/07/2013
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 02/07/2013
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 28/06/2013