Adverse event reporting
What must be reported to Medsafe, reporting timeframes, how to submit a report, and exemptions from reporting obligations in New Zealand.
Recalls and FSCAs
When a recall or Field Safety Corrective Action is required in New Zealand, how to notify Medsafe, how to issue a Field Safety Notice, and how WAND supports the process.
Labelling and advertising
Labelling requirements under GHTF/SG1/N43:2005, IFU obligations, advertising rules under the Medicines Regulations 1984, and the absence of UDI requirements in New Zealand.
Post-market surveillance
Post-market surveillance obligations for NZ Sponsors — what is required, distribution records, and how NZ compares to the EU and Australian PMS frameworks.