Cancellations and suspensions

The sponsor did not provide sufficient 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.

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 29/07/2024

The device was Suspended under section 41GA of the Act, and the period of suspension of the Device from the ARTG has expired. Therefore, the suspended ARTG must be cancelled as per section 41GK of the Act, effective 21/06/2024

The device was Suspended under section 41GA of the Act, and the period of suspension of the Device from the ARTG has expired. Therefore, the suspended ARTG must be cancelled as per section 41GK of the Act, effective 24/06/2024

The device was Suspended under section 41GA of the Act, and the period of suspension of the Device from the ARTG has expired. Therefore, the suspended ARTG must be cancelled as per section 41GK of the Act., effective 21/06/2024

Regulatory action due to Under paragraph 41FA(1)(b); the conformity assessment certification applying to the Device has been suspended by the Notified Body, effective 1/05/2024

The devices were Suspended under section 41GA of the Act, and the period of suspension of the Device from the ARTG has expired. Therefore, the suspended ARTG must be cancelled as per section 41GK of the Act., effective 21/06/2024

The devices were Suspended under section 41GA of the Act, and the period of suspension of the Device from the ARTG has expired. Therefore, the suspended ARTG must be cancelled as per section 41GK of the Act, effective 21/06/2024

The delegate is satisfied that the requirements of section 41GD of Act are met and I am revoking the suspension of the Device from the ARTG., effective 21/06/2024

The delegate is satisfied that the requirements of section 41GD of Act are met and I am revoking the suspension of the Device from the ARTG., effective 21/06/2024

The device was Suspended under section 41GA of the Act, and the period of suspension of the Device from the ARTG has expired. Therefore, the suspended ARTG must be cancelled as per section 41GK of the Act., effective 21/06/2024

The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (paragraph 30(2)(c) of the Act).

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 17/06/2024

Regulatory action due to Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable., effective 17/06/2024