Consultations

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

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

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

proposed web pages
presentation of the hypothetical examples
proposed communication channels

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.

Early warning system submission: Centre for Adverse Reactions Monitoring (pdf 22KB 2 pages)
Early warning system submission: Medical Technology Association of New Zealand (pdf 130KB 2 pages)
Early warning system submission: Medicines New Zealand (pdf 125KB 3 pages)
Early warning system submission: New Zealand Nurses Organisation (pdf 14KB 1 page)
Early warning system submission: New Zealand Self Medication Industry (pdf 26KB 4 pages)
Early warning system submission: PHARMAC (pdf 49KB 1 page)
Early warning system submission: Pharmaceutical Society New Zealand (pdf 20KB 2 pages)

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)