Revised: 8 March 2013
Consultations
Joint Medsafe and TGA project: Trans-Tasman Early Warning System of Safety Concerns with Medicines and Medical Devices
Closing date: 7 April 2013
Consultation documents
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 New Zealand and Australia and includes example web pages.
Link to a pdf copy of the consultation document (Adobe pdf document 488 KB)
Link to a word copy of the consultation document (Microsoft Word document 346 KB)
Invitation to comment
Medsafe is seeking comments and input from interested parties on the proposed process and example web pages for an early warning system for medicines and medical devices. The TGA is running a parallel consultation. This scheme will operate in parallel in New Zealand and Australia. 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 New Zealand and Australia.
- Example web pages including hypothetical safety communications are included in the consultation.
Through the consultation process, Medsafe and TGA 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.
Pharmaceutical companies and device manufacturers are requested to provide contact details to Medsafe if they wish to receive copies of communications, as outlined in the process document.
How to respond
Please complete the Medsafe consultation submission template. This is available in Microsoft Word format 53 kb or Adobe PDF format - 518 kb. Submissions must include full personal or organisational contact details (including address, telephone number and email).
Electronic submissions are preferred which should be emailed to medsafeadrquery@health.govt.nz including 'Early Warning System' in the subject line of the email.
Alternatively, hard copy submissions may be mailed to:
Clinical Risk Management
Medsafe
PO Box 5013
Wellington 6140
What will happen
Submissions will be reviewed by Medsafe and the TGA and feedback on submissions will be provided through the Medsafe and TGA websites. Input on the early warning system will be used to help inform the New Zealand and Australian governments on implementation of this system.
Confidentiality
All New Zealand submissions will be placed on the Medsafe 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 Medsafe 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 Medsafe by email to medsafeadrquery@health.govt.nz
