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Wednesday, 7 March 2001
Page: 25337


Mr McGAURAN (Minister for the Arts and the Centenary of Federation) (7:22 PM) —I move:

That the bill be now read a second time.

The provisions in this bill are necessary to allow the introduction of a redeveloped and refined system for electronically listing medicines on the Australian Register of Therapeutic Goods.

The new system will bring benefits to consumers. It provides a strong basis for consumer confidence in the safety and quality of listable medicines, whilst facilitating market access by industry. It will also provide consumers with quicker access to the latest advances in complementary medicines and maximise consumer choice.

Under the changes introduced by the bill, providers of listable medicines will have greater responsibilities and accountability in relation to the certification of the medicines they wish to list on the register and the Therapeutic Goods Administration will significantly enhance post-market monitoring, testing and surveillance in relation to these products.

It should be noted that listable, or listed, medicines are considered to be of low risk based on their ingredients and therapeutic indications and claims. Most complementary medicines, such as herbal, vitamin and mineral products, fall into this category.

Some over-the-counter medicines and sunscreens also fall into this category.

These low risk products will be entered on the new electronic lodgement facility (ELF). This system will apply the same rules that are currently being applied through deskbased assessment but will be applied electronically, based on programming relating to the regulations and other legislation.

Any data entered that does not fall into the parameters required will result in the rejection of an application.

The criteria for quality, safety and efficacy that currently apply to listed medicines will continue to apply under the new listing arrangements.

It is important that any streamlining of market access for a medicine through the ELF system is balanced with a strengthened and systematic post-market monitoring system.

The provisions in this bill help to strengthen the post--market system for listed medicines. The powers of the Therapeutic Goods Administration to require information and samples will be enhanced and sanctions strengthened. Penalty provisions for providing false information or data on a product will be significantly enhanced.

Furthermore, the implementation of this new listing system will enable significantly more resources within the TGA to be applied to the post--market monitoring of these products.

This bill is an important advance in the regulation of complementary and other listed medicines. It will deliver benefits to both consumers and industry in streamlining market access for new low risk medicines. At the same time consumer confidence is enhanced by the continued application of the existing requirements in relation to quality, safety and efficacy with a strengthened post-market monitoring system.

I will seek leave to table the explanatory memorandum before the adjournment. I commend the bill to the House.