As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
Adverse events are unintended and sometimes harmful occurrences associated with the use of a medicine, vaccine or medical device. Adverse events include side effects to medicines and vaccines, and problems or incidents involving medical devices.
Examples of adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good. An abnormal laboratory finding could be one example of an unfavourable and unintended sign.
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PageInformation on how to report an adverse event or serious public health threat or concern for medical devices.
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PageInformation on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
Guidance and resources
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PublicationsThese guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity
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