Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated problem.
New Zealand is a member of the WHO International Drug Monitoring Programme based in
Uppsala, Sweden.
Medsafe has an established pharmacovigilance system for collecting and evaluating
information relevant to the benefit-risk balance of approved medicines in New Zealand.
This Pharmacovigilance guideline provides information for sponsors about their
pharmacovigilance obligations and responsibilities for medicines that are approved by
Medsafe and for medicines imported under s29 of The Act. The guideline also includes
recommendations to sponsors that are not currently underpinned by medicines legislation
and provides guidance on best practice of pharmacovigilance…
