Medsafe oversees medicine safety in New Zealand and works with the Centre for Adverse Reactions Monitoring (CARM) to operate the national pharmacovigilance database.
Core official resources
- Adverse reaction reporting for medicines — guidance for industry — sponsor-facing ICSR reporting requirements and routes.
- Adverse Reaction Reporting — central public reporting and safety-information hub.
- Report a Problem — reporting routes for medicine, vaccine and device safety issues.
- Requesting adverse reaction information — guidance for industry — how sponsors can request relevant deidentified national PV data.
Practical use
Medsafe's current industry guidance requires valid serious New Zealand ICSRs to be submitted within 15 calendar days and gives specific routes for submission. Check the current Pharmacovigilance Guideline and product-specific conditions when defining broader sponsor obligations.