Adverse Experience Reporting Program annual reports

The way that we report data collected from the Adverse Experience Reporting Program (AERP) has changed. AERP annual reports spanning 2004–2013 should not be compared with those reports published for 2014 and beyond.

AERP annual reports prior to 2014 published the details of an event in the year that the adverse report was ‘classified’ by the APVMA, rather than the year in which the event occurred.

We routinely receive reports of adverse events that occurred in the past. Over 40 per cent of adverse experience reports are sent to the APVMA in the year following the date of the original event. This means annual reports published prior to 2014 include data relating to events that may have occurred outside, or prior to, that calendar year.

To enhance transparency and improve the utility of the reports, we now publish the details of adverse experiences in the year that they occurred, regardless of when the adverse report was received or classified by the APVMA.

Why is this important? The year in which the event occurs is very important for deciding what, if any, regulatory action is required to ensure registered veterinary medicines and agricultural chemical products sold in Australia are safe and effective.

The APVMA may periodically update reports published for 2014 and beyond to include additional data not previously on hand.

Pre-2014

Pre-2004

 

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