Cancellations and suspensions

Regulatory action due to Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 25/10/2019

Regulatory action due to Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 25/10/2019

Regulatory action due to Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 18/10/2019

Regulatory action due to Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 11/09/2019

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable. It appeared to the Secretary that a certification made by the sponsor under paragraph 26A(2)(b) of the Act was incorrect. The Secretary was satisfied that a statement made in, or in connection with, the application for listing of the goods was false or misleading in a material particular. The goods did not conform to a standard applicable to the goods., effective 02/09/2019

Regulatory 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 20/08/2019

Regulatory 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 20/08/2019

Regulatory 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 20/08/2019

Regulatory 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 Request for Information Notice., effective 19/08/2019

Regulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations.As it appeared to the Secretary that the presentation of the goods was unacceptable, the certification made under s.26A(2)(c) of the Act was incorrect.The sponsor failed to comply with a condition of listing under s.28(5)(ab) of the Act (that the goods would not be advertised for an indication other than those accepted in the Register).The goods do not conform to a standard applicable to the goods., effective 31/07/2019

Regulatory action due to Voluntary revocation at the request of the manufacturer., effective 25/07/2019

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable.As there was insufficient information or evidence to support the claims about the product, the certification made under s.26A(2)(j) of the Act was incorrect., effective 22/07/2019

Regulatory 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 section 41JA., effective 18/07/2019

Regulatory action due to The certification the sponsor made under section 41FD of the Act in relation to the application for inclusion of the kind of device in the Register is incorrect, or is no longer correct, in a material particular., effective 16/07/2019

Regulatory 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 16/07/2019

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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

Regulatory 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