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Joint TGA and Medsafe project: Trans-Tasman early warning system of safety concerns with medicines and medical devices

Related information

Consultation

8 March 2013

This consultation closed on 7 April 2013

Consultation documents

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The consultation document is titled: The Trans-Tasman early warning system: How the process will work in Australia and New Zealand. This document contains a description of the proposed process for the early warning system for Australia and New Zealand and includes example web pages.

Invitation to comment

The TGA sought comments and input from interested parties on the proposed process and example web pages for an early warning system for medicines and medical devices. Medsafe is running a parallel consultation. This scheme will operate in parallel in Australia and New Zealand. Comments will be used to inform the process for both countries.

Timetable

Document released for consultation on 8 March 2013.

Interested parties should respond by close of business 7 April 2013.

Feedback will be released following consideration of submissions (see 'What will happen').

About the consultation

  • This discussion/information paper outlines a description of the proposed process for a parallel early warning system for safety concerns with medicines and medical devices in Australia and New Zealand.
  • Example web pages including hypothetical safety communications are included in the consultation.

Through the consultation process, the TGA and Medsafe are seeking comments from interested parties on the:

  • proposed webpages
  • presentation of the hypothetical examples
  • proposed communication channels.

Content of submissions

Submissions may address any, or all, of the following areas:

  • the proposed webpages
  • the presentation of the hypothetical examples
  • the proposed communication channels.

In addition, submissions may include general comments on the proposed scheme.

What will happen

Submissions will be reviewed by the TGA and Medsafe and feedback on submissions will be provided through the TGA and Medsafe websites. Input on the early warning system will be used to help inform the Australian and New Zealand governments on implementation of this system.

Confidentiality

All Australian submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be 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 TGA 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 the TGA by email to ews.consultation@tga.gov.au.

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Content last updated: Friday, 8 March 2013

Content last reviewed: Friday, 8 March 2013

Web page last updated: Thursday, 31 October 2013

URL: http://www.tga.gov.au/newsroom/consult-anztpa-early-warning-system-130308.htm