The Australia New Zealand Therapeutic Products Authority Newsletter 3

The Australia New Zealand Therapeutic Products Authority Project
Newsletter No 3, September/October 2006

This newsletter aims to provide regular information and updates to New Zealand industry and other stakeholders about the proposal to establish a trans-Tasman regulator for therapeutic products.

Submissions analysis

The analysis of submissions on the draft Rules for medicines, medical devices and administrative matters, along with the discussion paper on the proposals for fees and charges is currently underway.

Submissions on these consultation documents closed on 15 August 2006. Around 221 individual submissions were received, along with a number of generic-style submissions.

The submissions are being analysed jointly by officials from New Zealand’s Medsafe and Ministry of Health and Australia’s Therapeutic Goods Administration and its Department of Health and Ageing.

Following that process, recommendations will then be made to the two Ministers on the Therapeutic Products Interim Ministerial Council. A summary of issues raised in submissions and the next steps are expected to be published towards the end of the year.

Next consultation round

Submissions are now being invited on further aspects of the proposed regulatory scheme for the Australia New Zealand Therapeutic Products Authority (ANZTPA).

Documents released for consultation on 18 October 2006 include:

The proposed medicines scheduling provisions of the draft Administration and Interpretation Rule which details the proposed scheduling processes for medicines under ANZTPA.
A consultation paper on the proposed regulation of blood under ANZTPA.
Consultation Paper on proposed pharmacovigilance and device vigilance (product vigilance) functions of the ANZTPA.

Submissions close on 6 December 2006. Accompanying resource documents including a Plain English Guide to the proposed medicines scheduling provisions of the draft Administration and Interpretation Rule and a copy of a proposed ANZTPA Product Licence are also available.

These documents can all be downloaded from the ANZTPA website

This year we have entered into an intensive phase of consultation on the proposed joint regulatory scheme to provide the opportunity for industry, other stakeholders and consumers to provide feedback and to help inform the development of the new regulatory scheme.

Open minded consultation is crucial in ensuring the proposed new regulatory scheme is workable and meets the overall objective of safeguarding public health and safety in both Australia and New Zealand.

Any questions you may have that relate to submissions or the consultation documents can be emailed to consultation@anztpa.org.

Further information about the 2006/2007 consultation programme on the proposed joint regulatory scheme is available at: www.anztpa.org/consult/programme0607.htm

Information to help you when preparing your submission

Submissions will be more effective if they are specific, well organised and contain adequate information and examples to support the views being made.

Points to keep in mind when preparing your submission:

Clearly identify which consultation document your submission relates to.
Clearly state the Part or Division of the draft Rules or the section number/heading in the consultation papers that your views or comments relate to.
Be specific when explaining your points and where appropriate provide additional information or give examples.
Clearly explain how the proposals might affect you and suggest how the effects could be minimised or avoided.
If you wish to suggest alternatives to the proposed regulatory approach, provide information about what you would propose instead and why it should be considered.
Mark as confidential any information in your submission which you would like to be treated as confidential.
Include a completed submission cover form containing your details which is available from the ANZTPA website

Submissions can be sent:

By email to: consultation@anztpa.org

Or by post in New Zealand to:

c/- Joint Agency Establishment Group
Medsafe
The Ministry of Health
PO Box 5013, Wellington

Frequently Asked Questions

Questions and answers about the proposed joint regulatory scheme and the phase one consultation documents can now be seen on the ANZTPA website.

Topics covered include questions and answers about consultation, governance and accountability; fees and charges proposals; medical devices; complementary medicines; and over-the-counter and prescription medicines.

Therapeutic Products Interim Ministerial Committee

At the last meeting of the Interim Ministerial Council, which was held in Wellington, the New Zealand Minister for State Services, Annette King, and the Australian Parliamentary Secretary for Health, Christopher Pyne, ratified the appointments of the chair, deputy chair and membership of a new Advertising Implementation Steering Group.

The steering group will provide guidance on implementing proposals for the joint regulation of the advertising of therapeutic products under the proposed trans-Tasman Authority.

Sue Knowles, formerly an Australian senator, has been appointed as the chair of the steering group. Tony Miller, the chief executive of New Zealand's Self Medication Industry Association, has been appointed to the role of deputy chair.

Microbiological Standards for Medicines

Submissions on the proposed joint microbiological standards for medicines closed on 15 September. Issues under consideration include how the preservative efficacy of sterile and non-sterile multidose medicines, and the microbial attributes of non-sterile medicines, can be assured. An update will be provided once the submissions have been considered.

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