Second phase of ANZTPA consultation documents released
18 October 2006
Please note: This consultation closed on 6 December 2006.
The second phase consultation on the proposed joint regulatory scheme for the new Australia New Zealand Therapeutic Products Authority (ANZTPA) has commenced with the release of the following documents for public consultation:
Consultation Paper on the Proposed Regulation of Blood under ANZTPA (pdf,161kb)
Consultation Paper on Product Vigilance in ANZTPA (pdf,94kb)
The closing date for submissions on the consultation documents was 6 December 2006.
In addition the following accompanying resource documents are also available:
Other consultation documents are expected to be published over the coming months.
This is the second of three substantive consultation phases on the proposed regulatory scheme.
The proposed regulatory scheme aims to protect the health and safety of Australians and New Zealanders through jointly regulating therapeutic products in accordance with international best practice.
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.
Further information
Proposed medicines scheduling provisions of the draft Administration and Interpretation Rule
This component of the draft Administration and Interpretation Rule details the proposed scheduling processes for medicines under ANZTPA.
Consultation Paper on the Proposed Regulation of Blood under ANZTPA
This consultation paper has been developed to collect the views of stakeholders on the proposed regulation of blood under the Australia New Zealand Therapeutic Products Authority (ANZTPA). Submissions received on this consultation paper will be used to inform the development of the draft Rule for the regulation of Blood under ANZTPA.
Consultation Paper on Product Vigilance in ANZTPA
This consultation paper has been developed to collect the views of stakeholders on the proposed pharmacovigilance and device vigilance (product vigilance) functions of the ANZTPA. Submissions received on this consultation paper will be used to inform the development of the aspects of the draft Rules, Orders and guidelines which describe the ANZTPA product vigilance framework.
Accompanying resource documents
The Proposed ANZTPA Product Licence (pdf,77kb) reflects data that will be collected as part of the ANZTPA on-line systems. It is intended to provide a summary of the key elements of the ANZTPA Product Licence (including restrictions such as provisional status) so that licence holders are aware of the current approved licence for their product to be marketed in Australia and / or New Zealand.
A Plain English Guide (pdf,81kb) on the proposed medicines scheduling provisions of the draft Administration and Interpretation Rule is also available to provide context and assist readers’ understanding of the key features of the regulatory proposal.
URL: http://www.anztpa.org/consult/consdocs2.htm
PDF: http://www.anztpa.org/consult/dr-medschedinterp.pdf
PDF: http://www.anztpa.org/consult/dr-bloodreg.pdf
PDF: http://www.anztpa.org/consult/dr-vigilance.pdf
PDF: http://www.anztpa.org/consult/dr-medsched.pdf
PDF: http://www.anztpa.org/consult/dr-prodlicence.pdf