ANZTPA Orders
The framework for the joint regulatory scheme for therapeutic products to be implemented by the Australia New Zealand Therapeutic Products Authority (ANZTPA) will be developed in accordance with the Agreement (pdf,79kb) and implemented through Acts of Parliament in both countries.
The regulatory requirements of the scheme will be set out principally in Rules made by the Ministerial Council. Technical Orders made by the Managing Director on behalf of the Authority will provide a further level of regulatory detail.
The principles of several key Orders have already undergone stakeholder consultation (eg. labelling requirements for medicines and child-resistant packaging). In the lead up to the establishment of ANZTPA, Orders will be progressively prepared in consultation with stakeholders.
This webpage will provide a central resource for stakeholders looking for the technical details to be contained in Orders. As draft Orders are prepared, they will be published on this webpage as consultation drafts for stakeholder feedback.
Once stakeholder submissions have been considered, the final draft Orders will be published on this page for the information of stakeholders. Orders are to be made by the ANZTPA Managing Director, thus establishing them in law. They will need to be tabled in both Australian and New Zealand Parliaments, and will be disallowable by either Parliament.
Draft Orders for consultation
- Nil
Draft Orders on which consultation is complete
- Draft Order: Medical Device Standards for Medical Devices Required to be Sterile
Closed 13 July 2007 - Draft Order: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques for the Manufacture of Medical Devices
Closed 13 July 2007 - Draft Order: Packaging Requirements for Specified Therapeutic Products
Closed 13 July 2007 - Draft Order: Medical Device Standards for Clinical Evidence
Closed 4 May 2007 - Draft Order: Medical Device Standards for Risk Management
Closed 4 May 2007 - Draft Order: Conformity Assessment Standards for Quality Assurance Techniques for Animal Tissues and their Derivatives Utilised in the Manufacture of Medical Devices
Closed 4 May 2007 - Revised Draft Order: General Requirements for the Labelling of Medicines
Closed 22 August 2006 - Description of the Proposed Grouping Order for Medicines
Closed 15 August 2006 - Draft Order Child-Resistant Packaging of Therapeutic Products
Closed 19 May 2006
Final Draft Orders - for information only
Note: The layout / formatting of final Orders may differ slightly from that of the draft 'Final Draft Orders' included below, in order to satisfy legislative drafting requirements.
Final Draft Order: Medical Device Standards for Risk Management (MDSO 2) (pdf,22kb)
20 June 2007
URL: http://www.anztpa.org/consult/orders.htm