New Zealand

Pharmacovigilance in New Zealand is administered by the Ministry of Health – Manatū Hauora through Medsafe under the Medicines Act 1981 and GRTPNZ: Pharmacovigilance, Edition 3.0, effective 1 July 2024. The sponsor must have a New Zealand legal presence under GRTPNZ Part 2 and should nominate a pharmacovigilance contact, preferably in New Zealand or contactable during local business hours; Medsafe should be notified within 15 days of approval or a change. New Zealand does not use the EU QPPV title or require an EU-style PSMF. Serious valid New Zealand ICSRs are due within 15 calendar days; non-serious cases are retained for signal evaluation. Confirmed significant safety issues are due within 72 hours and other safety issues requiring action within 30 days. PBRERs are routine only for specified products or when conditioned or requested, while RMPs may be requested during evaluation, as an approval condition or following a safety concern. Medsafe may inspect sponsor compliance and supporting records. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.