Skip to Content
Skip to Main Navigation
Skip to Local Navigation
Skip to Search

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

8 January 2013

This consultation closed on 21 February 2013

Consultation documents

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 sought 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 responded 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 anztpa.submission@anztpa.org 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 anztpa.info@anztpa.org