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Pharmacovigilance in New Zealand
📢 DDReg Knowledge Capsule – Episode [9]Overview of pharmacovigilance in New Zealand, highlighting the regulatory framework overseen by Medsafe under the Medicines Act 1981. It explains that the country participates in the WHO International Drug Monitoring Programme and uses systems like the Suspected Medicine Adverse Reaction Search (SMARS) database to gather post-market safety information. The text outlines the responsibilities of pharmaceutical sponsors, including appointing a contact person and adhering to strict timelines—such as reporting serious adverse reactions within 15 days and…
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