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Thursday, 17 February 2000
Page: 13845

Mr GRIFFIN (11:15 AM) —I will be very brief. This is obviously an important bill in relation to our relations with Iceland, Liechtenstein and Norway. It is a non-controversial piece of legislation that extends a mutual recognition agreement currently covering European Union countries to include those three nations. Australia entered into the original MRA in 1997. In order to implement part of the agreement parliament passed the Therapeutic Goods Amendment Act 1997. This legislation allowed the Secretary of the Department of Health and Aged Care to accept conformity assessment certificates issued by conformity assessment bodies in the EU.

The MRA states that therapeutic goods manufactured in EU countries, including registrable medical devices and listable devices to which the certificates apply, meet all Australian regulatory requirements relating to quality, safety and efficacy. Acceptance of the certificates precludes the need for further evaluation or assessment of the products before they are included in the Australian register of therapeutic goods and approved for general marketing. The current bill extends the MRA to three members of the European Economic Area: Liechtenstein, Iceland and Norway. The MRA will lead to a decrease in regulatory cost to Australian companies wishing to export therapeutic goods, including registrable medical devices and listable devices, to the EEA and to EEA companies exporting to Australia.

I do not think I can say much more directly on the bill other than that I wish it a speedy passage. I certainly intend to support that passage. I am hopeful that the member for Bradfield is now ready to say something about the bill.