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 sponsor failed to comply with a condition of listing under s.28(5B)(a) of the Act (that each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step).The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 23/02/2016
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of listing under s.28(5B)(a) of the Act (that each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step).The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 23/02/2016
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of listing under s.28(5B)(a) of the Act (that each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step).The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 23/02/2016
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Cancellation or suspensionRegulatory action due to The sponsor failed to comply with a condition of listing under s.28(5B)(a) of the Act (that each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step).The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 23/02/2016
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Cancellation or suspensionRegulatory action due to It appeared to the Secretary that the presentation of the goods was unacceptable.The goods have changed so they have become separate and distinct from the goods included in the ARTG.As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect. The goods do not conform to a standard applicable to the goods., effective 05/02/2016
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Dressing, hydrogel (Cancelled from the ARTG under s. 41GL(d) and the ARTG entry varied under s.41GO)
Cancellation or suspensionRegulatory action due to The sponsor requested in writing the cancellation of these devices from the ARTG entry., effective 02/02/2016 -
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 29/01/2016
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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) was incorrect. The goods do not conform to a standard applicable to the goods., effective 22/01/2016
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 18/01/2016
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Cancellation or suspensionRegulatory action due to The goods were not eligible for listing as they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 18/01/2016