Pharmacovigilance
Sponsors obligations under the Medicines Act 1981
Medsafe is the regulatory agency responsible for overseeing pharmacovigilance activities in New Zealand. Medicine importers and manufacturers 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 operation, Medsafe interprets this clause as requiring sponsors to report adverse reactions occurring within New Zealand that are either serious or unexpected (unlisted), and to report these to the Centre for Adverse Reactions Monitoring (CARM) in Dunedin. Adverse reactions occurring in other countries are not required to be reported routinely, although Medsafe reserves the right to require sponsors to submit an analysis of these reports if requested.
Additionally, if reports of adverse reactions in other countries have prompted an investigation by either the sponsor or regulatory authority in that country, then Medsafe should be informed.
Good pharmacovigilance practice
Medsafe asks that sponsors promptly inform the Medsafe Pharmacovigilance Team of the following:
- investigations of safety issues by an overseas regulatory authority
- new or revised safety information necessitating a change in the data sheet
- any emergent medicine-safety concerns
- proposed "Dear Doctor/Health Professional" letters.
Forward all pharmacovigilance correspondence to:
Medical Advisor, Pharmacovigilance Team, Medsafe, PO Box 5013, Wellington
Dear Doctor/Health Professional letters
Medsafe asks that for all proposed "Dear Doctor/Health Professional" letters sponsors seek input and comment from Medsafe prior to the finalisation and distribution of the letter. Please contact the Medical Advisor at Medsafe.
Additionally, a copy of the final version of "Dear Doctor/Health Professional" letters must be sent to the Medical Advisor at Medsafe in advance of the letter being distributed to doctors/health professionals.
Post-marketing surveillance
Post-marketing surveillance of medicines in New Zealand includes the spontaneous adverse reactions reporting scheme (CARM) and an Intensive Medicines Monitoring Programme (IMMP) - both managed by the New Zealand Pharmacovigilance Centre in Dunedin, under contract to Medsafe.
Send New Zealand adverse reaction reports to CARM:
Freepost 112002
The Medical Assessor
CARM
PO Box 913
Dunedin
Phone (03) 479 7247 or Fax (03) 479 7150
E-mail: carmnz@stonebow.otago.ac.nz
Reporting forms can be downloaded from the Information for Health Professionals section or the CARM website.
Clinical Trials
The requirements for the reporting of adverse reactions occurring in clinical trials are specified in Volume 3 of the NZ Regulatory Guidelines for Medicines, section 6 (available from New Zealand Regulatory Guidelines for Medicines- volumes 1- 4).
Medsafe will also accept reports of clinical trial adverse reactions when these are submitted in the format and timescale required by the Australian TGA and the ICH Guidelines for Good Clinical Practice.
Further information
More details about the requirements of sponsors to report adverse reactions can be found in Volume 1 of the New Zealand Regulatory Guidelines for Medicines (Microsoft Word document 5,620KB), section 19.