Medsafe, part of the Ministry of Health, is responsible for pharmacovigilance activities in New Zealand. The collection of reports of suspected adverse reactions to medicines is contracted by the Ministry of Health to the Centre for Adverse Reactions Monitoring (CARM) in Dunedin. CARM analyses these reports and informs Medsafe of any potential medicine safety issues arising from these reports. It is Medsafe's responsibility to investigate and action safety issues arising from these reports and other sources of information.
Sponsors Obligations under the
Medicines Act 1981
Medicine importers and manufacturers (sponsors) have a statutory obligation (under section 41 of the Medicines Act 1981) to report untoward effects of medicines to the Director-General of Health. In practice this means that single case reports of suspected adverse reactions to approved medicines should be reported to CARM and information on new potential safety signals should be reported to Medsafe.
Suspected Adverse Reaction Reports
In general the ICH E2D guideline should be followed.
Cases meeting the following criteria should be sent to CARM:
- All serious cases occurring in New Zealand.
- All cases must be valid as specified in ICH E2D
- All serious literature reports of New Zealand cases where an identifiable patient is the subject of the report; the reference should be included with the report.
- Unblinded clinical trial reports for approved medicines included in studies conducted in New Zealand.
Do NOT report
- Cases occurring outside New Zealand
- Non-serious cases
- Clinical trial cases for unapproved medicines; the reporting requirements for these cases are specified in Part 11 of the Guideline of Therapeutic Products in New Zealand. (http://www.medsafe.govt.nz/regulatory/guidelines.asp)
- Blinded clinical trial cases for approved medicines; these may be reported once the medicine has been identified.
Where significant additional information for a case has been received this should be forwarded to CARM. Please quote the CARM reference number and the date of the original report when sending further information.
Reports may be made on CIOMS or CARM forms and should be sent to
The Medical Assessor
PO Box 913
FAX +64 (0)3 4797150
New Potential Safety Issues
Sponsors should promptly inform Medsafe of any significant safety concerns with their medicines. For example:
- Investigations of safety issues by another medicines regulator.
- When their review and analysis has concluded that a safety issue exists.
- Issues for which the sponsor is considering sending a Dear Health Care Professional Letter.
- Significant safety results from post marketing studies.
Dear Healthcare Professional Letters should be submitted to Medsafe for review and a final copy provided prior to distribution.
Periodic Safety Update Reports
and Risk Management Plans
Medsafe does not require routine submission of PSURs or RMPs, but may request them for specific medicines.
Section 36 of the Medicines Act 1981 allows for a review of the benefits and risks of a medicine. If such a review is conducted the sponsor will be informed in writing; the sponsor is allowed 60 days to respond. As a result of this review action may be taken to prohibit the supply of the medicine or impose conditions on the supply of the medicine. Sponsors requiring more information in the event of such a review should contact Medsafe (see below).
Correspondence should be addressed to the Manager of Clinical Risk Management and sent to:
FAX +64 (0)4 8196806
PO Box 5013