Stakeholder consultation programme 2006/07

Introduction
Consultation phase one
Consultation phase two
Consultation phase three
Other consultation
Questions & answers from stakeholder meetings held during Phases 1, 2 and 3
ANZTPA stakeholder meetings
Presentations from the June 2006 ANZTPA Stakeholder Information Meetings
Presentations from the May 2007 ANZTPA Stakeholder Workshops
Australia and New Zealand have been working together since the late 1990s to develop a world-class joint regulatory scheme for therapeutic products that will protect and safeguard public health and safety now and into the future.

It’s proposed that a joint scheme to regulate prescription and over-the-counter medicines, complementary medicines, medical devices, blood and blood products and cellular therapies be established under the trans Tasman agency called the Australia New Zealand Therapeutic Products Authority (ANZTPA).

During 2006/07 there will be a phased release of documents for public consultation. This will include the draft Ministerial Council Rules, which contain the detail of the proposed joint regulatory framework for therapeutic products, and the draft Orders which define specific technical standards.

Consultation on the draft Rules and draft Orders will occur in three phases:

Phase 1: From May 2006
Phase 2: From October 2006
Phase 3: From March 2007
All consultation documents will be published on the ANZTPA website (www.anztpa.org) and written submissions invited.

During the consultation phases, meetings will be arranged where appropriate, to provide an opportunity for key stakeholders to find out more about the proposals, ask questions and provide preliminary feedback to officials on the consultation documents.

All submissions will be taken into consideration as part of the development of the final Rules and Orders.

Additional consultation on the more technical aspects of the regulatory scheme will also take place during 2006/2007 as the proposals are developed. Feedback from these consultations will be used to inform the development of the Orders.

Consultation on the implementing legislation (the Australian and New Zealand Bills) is being undertaken as part of the parliamentary processes of each country. In New Zealand, consultation on the New Zealand Therapeutic Products Bill is occurring as part of Select Committee consideration of the Bill. In Australia, consultation on the Australian Therapeutic Products Bill occurred with the release of an exposure draft of the Bill. Consultation on the Australian Exposure Draft closed on 4 May 2007.

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Consultation phase one
The following documents were released for consultation 23 May 2006. Submissions closed on 15 August 2006.

Draft Medicines Rule (pdf,489kb)
Proposed Grouping Order for medicines (pdf,53kb)
Draft guideline on transition provisions for product licensing (pdf,133kb)
Draft Medical Devices Rule (pdf,754kb)
Draft Administration Rule (pdf,330kb)
Consultation document on the proposed fees and charges (pdf,353kb)
Following release of these documents, a series of stakeholder meetings were held in Australia and New Zealand during June 2006: Presentations from the June ANZTPA Stakeholder Information Meetings.

Questions arising during the Phase 1 stakeholder meetings have been collated and answers prepared in a Q&A webpage format: Questions & answers from the Phase 1 Stakeholder Information Meetings
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Consultation phase two
The following consultation documents were released for consultation on 18 October 2006. Submissions closed on 6 December 2006.

Proposed medicines scheduling provisions of the draft Administration and Interpretation Rule (pdf,115kb)
Consultation Paper on Product Vigilance in ANZTPA (pdf,94kb)
Consultation Paper on the proposed Regulation of Blood under ANZTPA (pdf,161kb)
Following release of these documents focus group meetings with key stakeholder groups were held in Australia and New Zealand during November 2006.

The Draft Advertising Rule (pdf,380kb) released for consultation on 17 January 2007. Submissions closed on 14 March 2007.

Key stakeholder groups were invited to focus group meetings which were held in Australia and New Zealand during February 2007.

Questions arising during the Phase 2 stakeholder meetings have been collated and answers prepared in a Q&A webpage format: Questions & answers from the Phase 2 Stakeholder Information Meetings
The consultation paper: Proposed clinical trial regulatory arrangements under the Australia New Zealand Therapeutic Products Authority (ANZTPA) (pdf,65kb) was released for stakeholder feedback on 21 February 2007. The closing date for submissions was 18 April 2007.

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Consultation phase three
Phase 3 of the ANZTPA Stakeholder Consultation Programme 2006/07 began on 4 April 2007, with the release for stakeholder consultation of three draft Orders relating to medical devices. The first three draft Orders were published on the following webpage ANZTPA Orders which has been developed to provide a central space for stakeholders looking for the technical details to be contained in Orders.

The following documents (which constitute two of the major elements of this third phase of the consultation) were released for public consultation on 24 April 2007:

In-Vitro Diagnostic Devices (IVD) Revision Draft of the proposed Australia New Zealand Therapeutic Products Regulatory Scheme (Medical Devices) Rule 2007 (pdf,876kb)
Consultation Paper: The Regulation of Human Cellular and Tissue Therapies (HCTs) (pdf,219kb)
The closing date for submissions on the IVD Revision Draft of the Medical Devices Rule and the Consultation Paper on HCTs was 13 June 2007.

In addition the following accompanying resource document was also made available:

Plain English Guide: In-Vitro Diagnostic Medical Devices (IVDs) as included in the draft Medical Devices Rule (pdf,206kb)
Following the release of these documents, targeted focus group workshops were held in Australia and New Zealand during May 2007: Presentations from the May ANZTPA workshops
Questions arising during the Phase 3 stakeholder meetings have been collated and answers prepared in a Q&A webpage format: Questions & answers from the Phase 3 Stakeholder Information Meetings
Three further draft Orders were published on the ANZTPA Orders web page for stakeholder feedback during late May / early June 2007. In addition, the following scheduling-related documents were released for public consultation on 13 June 2007:

Draft Scheduling Policy Framework (pdf,450kb)
Draft Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (pdf,581kb)
The closing date for submissions on the draft SUSMP and the draft Scheduling Policy Framework was 25 July 2007.

Other consultation
Separate consultation will be undertaken for any Australian-only or New Zealand-only legislation that does not relate to the joint regulatory scheme.