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How does the Adverse Experience Reporting Program work?

22 December 2010

The Adverse Experience Reporting Program (AERP) is a program run by the APVMA to provide feedback about the performance of registered pesticides and veterinary medicines on the Australian market. The aim of the program is to ensure that registered products remain safe and effective and that instructions and warnings on product labels are appropriate.

More detail

The APVMA’s primary role is to assess and register pesticides and veterinary medicines proposed for use on the Australian market to see if they work and can be used safely subject to conditions the APVMA may impose. Products that are registered must be of a high quality, not pose a threat to people, crops, the environment and Australia’s international trade and continue to work effectively.

The AERP is designed to provide the APVMA with feedback about the performance of registered pesticides and veterinary medicines in the field to ensure that registration decisions made by the APVMA are appropriate and effective.

To achieve this the general community, state and territory authorities and chemical manufacturers are encouraged to report ‘adverse experiences’. These are unintended or unexpected negative effects on plants, animals, humans or the environment that flow from the use of pesticides and veterinary medicines when used according to label instructions.

Adverse experience reports received by the APVMA are assessed to determine their seriousness, if the problem was created by the legal appropriate use of a product and whether any regulatory action is required.

In assessing reports the APVMA may seek advice from the states and territories, other government agencies and independent experts. It then evaluates any advice it receives and makes a decision whether the relationship between the use of the product and the reported adverse experience is probable, possible, unlikely or unknown.

The APVMA reviews all events classified as ‘probable’ or ‘possible’ to look for possible trends. Have similar problems emerged with similar products? How many have occurred compared with the amount of the product sold? Are there clusters of similar adverse effects resulting from the use of the same or similar products?

Based on outcomes of this trend analysis, the AERP may recommend risk mitigation strategies or corrective actions. These recommendations may propose registration amendments such as label changes, review of the active constituent and products, changes to production line processes, compliance action or even suspension or cancellation of a product’s registration. This may also help identify the areas where community awareness should be directed.

Summaries and classifications of adverse experiences reports submitted to the APVMA involving legal use of a product are reported annually.

In 2009, for example, 2016 reports (1901 for veterinary medicines and 115 for pesticides) were classified.

In recent years, specific risk mitigation and corrective actions undertaken as a result of the AERP have included numerous changes to product labels to provide additional warnings, precautionary and restraint statements. Wide ranging activity designed to raise awareness of the program has also been undertaken.

Regulatory action is not taken if a causal link between exposure to a registered pesticide or veterinary medicine and an adverse event cannot be established.

Further information

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Last updated on 22 December, 2010