ANZTPA: Description of a possible joint regulatory scheme for therapeutic products under ANZTPA

8 January 2013

Closing date: 21 February 2013

Consultation documents
Invitation to comment
Timetable
About the consultation
Background
Content of submissions
How to respond
What will happen
Confidentiality
Enquiries
Consultation documents
How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

Description of a possible joint regulatory framework under ANZTPA

Consultation document in PDF – 372kb

Consultation document in Word – 115kb

Invitation to comment
The TGA and Medsafe are seeking comments and input from interested parties on a discussion paper setting out the high level features of a possible framework for regulation of therapeutic products within the ANZTPA-a joint scheme to regulate therapeutic products in Australia and New Zealand.

Timetable
Document released for consultation on 8 January 2013.
Interested parties should respond by close of business 21 February 2013
Feedback will be released following consideration of submissions. (see ‘What will happen’).

About the consultation
This discussion/information paper outlines a high level description of a possible joint regulatory scheme for therapeutic products under ANZTPA.
Through the consultation process, the TGA and Medsafe are requesting comment that will help to direct future work on the development of the regulatory framework for ANZTPA.
Content of submissions
Submissions may address any, or all, of the proposed amendments to the Description of a possible joint regulatory scheme for therapeutic products under ANZTPA or other identified issues.

In addition, submissions might include:

Suggested improvements
Whether or not you support the possible framework. If you do not support the possible framework as described, you may make suggestions for an alternative acceptable to you.
An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
Are there any areas where early harmonisation of processes between TGA and Medsafe would assist your business? Please list details of potential benefits for your business?
How to respond
All submissions should be accompanied by an ANZTPA consultation submission coversheet. This is available in Microsoft Word format – 29kb or Adobe PDF format – 20kb. Submissions must include full personal or organizational contact details (including address, telephone number and email).

Electronic submissions are preferred which should be emailed to [email protected] including ‘ANZTPA – Possible joint regulatory scheme’ in the subject line of the email.

Alternatively, hard copy submissions may be mailed to:

ANZTPA
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

What will happen
Submissions will be reviewed by the TGA and Medsafe and feedback on submissions will be provided through the ANZTPA Internet site.

Input and comment on the possible key features of the framework will be used to help inform Australian and New Zealand government decisions on the development of the common regulatory framework for use by ANZTPA.

As the project progresses and more details of the framework are developed you will have the opportunity to provide feedback.

Confidentiality
All submissions will be placed on the ANZTPA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked ‘IN CONFIDENCE’. Reasons for a claim to confidentiality must be included in the space provided on the submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the ANZTPA’s website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries
Any questions relating to submissions should be directed to ANZTPA by email to [email protected]

Content last updated: Tuesday, 8 January 2013

Content last reviewed: Tuesday, 8 January 2013

Web page last updated: Tuesday, 8 January 2013

URL: http://www.anztpa.org/consultation/Discussion_paper-ANZTPA_regulatory_scheme-20130107.htm

Copyright | Privacy & security | Disclaimer | Acronyms & glossary | www.australia.gov.au | www.health.gov.au | www.tga.gov.au | www.medsafe.govt.nz | www.moh.govt.nz | newzealand.govt.nz