Second phase of ANZTPA consultation documents released

18 October 2006

Introduction
Further information
Proposed medicines scheduling provisions of the draft Australia New Zealand Therapeutic Products Regulatory Scheme (Administration and Interpretation) Rule 2006
Consultation Paper on the proposed regulation of Blood under ANZTPA
Consultation Paper on Product Vigilance in ANZTPA
Accompanying resource documents
Making a submission
Questions relating to the consultation documents and submissions
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:

Proposed medicines scheduling provisions of the draft Administration and Interpretation Rule (pdf,115kb)

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 is 6 December 2006.

In addition the following accompanying resource documents are also available:

Plain English Guide to the proposed medicines scheduling provisions of the draft Australia New Zealand Therapeutic Products Regulatory Scheme (Administration and Interpretation) Rule 2006 (pdf,81kb)

Proposed ANZTPA Product Licence (pdf,77kb)

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.

Top of page

Further information about the consultation documents, including downloadable copies and information on how to make a submission:
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.

Proposed medicines scheduling provisions of the draft Australia New Zealand Therapeutic Products Regulatory Scheme (Administration and Interpretation) Rule 2006 (pdf,115kb)

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 the proposed regulation of Blood under ANZTPA (pdf,161kb)

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.

Consultation Paper on Product Vigilance in ANZTPA (pdf,94kb)

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.

Making a submission
Written submissions are invited on the consultation documents. Submissions can be sent by post or by email and should clearly identify which consultation document your submission relates to.

Submissions should include specific references to the Part or Division in question (for the draft Rules) or the section number / heading in the consultation paper(s).

It would be helpful if your submission included a completed submission cover form (rtf,42kb) including your name and company name, full contact details including address, telephone number and if applicable an email address or fax number.

Please clearly mark any information in your submission which you would like to be treated as confidential.

Submissions can be sent by email to: [email protected]

Or by post to:

ANZTPA consultation
c/- Joint Agency Establishment Group
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Australia
OR

c/- Joint Agency Establishment Group
Medsafe
Ministry of Health
PO Box 5013
Wellington
New Zealand
The closing date for submissions is 6 December 2006.

Questions relating to the consultation documents and submissions
Any questions relating to submissions or the consultation documents can be emailed to [email protected]