Published: 2 April 2015
Consultations
Guideline on the Regulation of Therapeutic Products in New Zealand. Part 8: Pharmacovigilance
Closing date: 13 May 2015
Consultation documents
The consultation document is titled: Guideline on the Regulation of Therapeutic Products in New Zealand. Part 8: Pharmacovigilance. Edition 2.0
This document is intended to explain sponsors’ responsibilities regarding pharmacovigilance and medicine safety issues.
This document expands on the existing guideline and describes the processes used for reporting suspected adverse reactions to medicines and/or safety concerns in greater detail. This update was written in response to questions from sponsors requesting further clarity and detail on the information in the previous edition.
Guideline on the Regulation of Therapeutic Products in New Zealand – Part 8: Pharmacovigilance (Edition 2.0) (Adobe pdf document 249 KB)
Guideline on the Regulation of Therapeutic Products in New Zealand – Part 8: Pharmacovigilance (Edition 2.0) (Microsoft Word document 288 KB)
Invitation to comment
Medsafe is seeking comments and input from interested parties on this proposed update.
Timetable
Document released for consultation on 2 April 2015.
Interested parties should respond by close of business 15 May 2015.
Feedback will be released following consideration of submissions. (see 'What
will happen')
About the consultation
- This edition of the guideline provides a fuller description of the pharmacovigilance processes that are already in place in New Zealand for the reporting of suspected adverse reactions to medicines or of other safety concerns about medicines.
- The underlying legal requirements and processes remain unchanged.
- This new edition constitutes a major revision of the existing guideline. It has been rewritten and expanded in response to sponsors' requests for greater clarity about the circumstances when adverse reaction reporting is required.
- The new edition includes additional sections on signal management, significant safety issues, safety monitoring documents and safety communications.
Content of submissions
Specific comments are sought on each section included in the guideline. In particular, Medsafe is seeking comments from interested parties on:
- the structure of the guideline
- whether the information is easily understood
- the circumstances described and included in the section on reporting (Section 3)
- other instances or situations that should also have been included
- any other information or subject that should be included in a guideline on pharmacovigilance.
However, submissions may address any or all of the sections of the guideline.
How to respond
Please complete the Medsafe consultation submission template.
Medsafe Pharmacovigilance guideline consultation submission template (Adobe pdf document 68 KB)
Medsafe Pharmacovigilance guideline consultation submission template (Microsoft Word document 56 KB)
Submissions must include full personal or organisational contact details (including address, telephone number or email address)
Electronic submissions are preferred which should be emailed to medsafeadrquery@health.govt.nz including 'Pharmacovigilance guideline' in the subject line of the email.
Alternatively, hard copy submissions may be posted to:
Clinical Risk Management
Medsafe
PO Box 5013
Wellington 6145
What will happen
Submissions will be reviewed by Medsafe and feedback on submissions will be provided on Medsafe's website. Input from submitters on the consultation draft will help inform the final shape, form or content of the guideline.
Confidentiality
All 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. These reasons must meet Official Information Act criteria if the submission (or part thereof) is not to be displayed.
For Official Information Act criteria, see: http://www.legislation.govt.nz/act/public/1982/0156/latest/DLM64785.html?search=qs_act_official+information+act_resel_25_h&p=3&sr=1.
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, or if you do not wish your submission to be associated with a party, 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
