Questions & answers about the overall proposed regulatory scheme
October 2006
What is the rationale for the definitions between the different levels and types of medicines?
The extent of regulation will depend on the type of therapeutic product and the level of risk associated with its use. The lower the risk to public health and safety the lighter the regulatory controls. Most complementary medicines are expected to be classified as low-risk. Higher-risk medicines will include most over-the-counter and all prescription medicines. Medical devices will also be divided into risk classes consistent with the international approach to the regulation of medical devices. Other therapeutic products such as some sunscreens, blood and blood components, tissues and cellular therapies, will also be regulated under the new Scheme.
What is the difference between Rules, Orders and Guidelines?
The Rules are made by the Ministerial Council and are similar to regulations. Orders are made by the Authority’s Managing Director. Because this will be a trans-Tasman scheme, there can be only one set of regulations and that is why a single set of Rules and Orders are being established for both countries. The Ministerial Council Rules will provide the fundamental regulatory requirements. The Managing Director’s Orders will provide more specific technical details such as the requirements and standards for medicines labelling. The Rules and Orders will be subject to scrutiny by the Parliaments of both countries in a similar way to domestic regulations and are disallowable instruments. The Guidelines sit underneath the Rules and Orders and provide a level of guidance or assistance in applying the Rules and Orders but are not legislative instruments.
If a Rule or an Order is disallowed in one country or another – what would happen?
If the New Zealand or Australian Parliament decided to disallow a Rule or Order then the effect would be that disallowance would apply in both countries. A new Rule or Order would then need to be made.
How would the proposed new scheme effect Australia’s free trade agreement with the United States which New Zealand is not a part of?
The proposal will not impact on Australia’s free trade agreement with the United States.
How would Official Information requests about commercially sensitive material be handled by the Authority?
The ANZTPA will be subject to the requirements of the New Zealand Official Information Act and the Australian Freedom of Information Act. There are grounds to withhold releasing commercially sensitive information in both statutes.
URL: http://www.anztpa.org/about/qascheme.htm