Medsafe Logo
Hide menus
Show menus

Consultations

Published: 22 May 2013

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

22 May 2013

About the consultation

Through the consultation process, Medsafe and the Therapeutic Goods Administration (TGA) sought comments from interested parties on the:

Consultation documents

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

Consultation: The Trans-Tasman early warning system: How the process will work in Australia and New Zealand (pdf, 488 KB, 40 pages)

Submissions received

Submissions received in response to the consultation paper are published below.

Note: Submissions have had personal information removed (where requested).

Consultation feedback

All submissions have been reviewed by the TGA and Medsafe. The feedback from this consultation has helped inform the Australian and New Zealand governments on implementation of this system. Attached below is a summary of the consultation submissions received in Australia and New Zealand and an outline of TGA’s and Medsafe's responses.

Summary of feedback on the Trans-Tasman early warning system: How the process will work in Australia and New Zealand consultation (pdf 180 KB, 6 pages)

Workshops

Prior to the consultation Medsafe and the TGA jointly hosted a number of workshops with key stakeholders. The purpose of the workshops was to gather information on the design of the system and how safety information should be communicated.

Workshop briefing document (pdf 119KB, 14 pages)

Summary of workshop feedback (pdf 258KB, 17 pages)

Enquiries

Any questions relating to submissions should be directed to Medsafe by email to medsafeadrquery@moh.govt.nz

0 1 2 4 5 6 7 9 [ /