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TRANS-TASMAN AUTHORITY SEEKS FEEDBACK

October 18, 2006

The Australia New Zealand Therapeutic Products Authority (ANZTPA) has begun a second phase of consultation on the proposed joint regulatory scheme and is asking for feedback. The two countries are working together to set up a joint regulatory scheme for complementary medicines, over-the-counter and prescription medicines, medical devices, blood and blood products and tissues and cellular therapies.

The aim of the agency is to develop a regulatory scheme that better protects the health and safety of consumers in Australia and New Zealand, according to the transitional director of the Joint Agency Establishment Group, Philip Davies. As part of the development of the joint scheme, submissions are now being sought on technical details pertaining to: The proposed medicines scheduling provisions of the draft Administration and Interpretation Rule;The proposed regulation of blood; and The proposed product vigilance arrangements.

"It is important to emphasize that we are consulting on draft rules and consultation documents and we are genuinely seeking constructive comments and suggestions that will be considered as part of the development of the joint regulatory scheme," Davies said.

The deadline for submissions is Dec. 6. The consultation documents can be downloaded at www.anztpa.org/consult/consdocs2.htm (http://www.anztpa.org/consult/consdocs2.htm).