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Thursday, 14 September 2017
Page: 10430


Mr HUNT (FlindersMinister for Health and Minister for Sport) (10:32): I move:

That this bill be now read a second time.

The Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017 amended the Therapeutic Goods Act 1989 to allow Australian corporations to be designated as Australian conformity assessment bodies. Once designated, these bodies will be able to undertake conformity assessments of manufacturers of medical devices.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 further amends the Therapeutic Goods Act to make it clear that an annual conformity assessment body determination charge is payable by the Australian corporation that is the subject of a determination.

This bill therefore makes consequential amendments to the Therapeutic Goods (Charges) Act 1989 to enable regulations to be made to specify the relevant amount of the charge. Different charges may apply depending on the scope of the conformity assessment body determination.

The introduction of such a charge will ensure that the Department of Health, through the Therapeutic Goods Administration, is able to recover the cost of its postmarket monitoring activities of conformity assessment bodies, which will ensure the safety and performance of the devices assessed by those bodies.

The bill also provides that where the    secretary suspends a conformity assessment body determination, the obligation for the conformity assessment body to pay an annual charge will continue during that period. This is because a suspension is temporary and during the suspension period the usual regulatory work in relation to the determination continues.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 also establishes a new provisional approval pathway for promising new prescription medicines. This bill clarifies that annual charges prescribed in relation to provisionally registered goods, will also apply to any provisionally registered goods entered in the Australian Register of Therapeutic Goods by Commonwealth officers in accordance with a corresponding state law. Similar provisions are currently in the charges act in relation to registered goods, listed goods, biologicals and medical devices.

I commend the bill to the House. I thank the opposition for their cooperation during this process and acknowledge the shadow minister.

Debate adjourned.