This content is current only at the time of printing. This document was printed on 30 October 2020. A current copy is located at https://apvma.gov.au/node/69
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Adverse Experience Reporting Program
The Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the use of a registered veterinary medicine or agricultural chemical.
It is vital to record, assess and classify adverse experiences to detect uncommon events not evident during the initial registration process of a product. The program provides a means of facilitating regulatory action that may be necessary to assure the continued safety, quality and effectiveness of registered products.
Anyone can report an adverse experience to the AERP, for example—farmers, pet owners, gardeners, veterinarians or the general public.
The AERP assesses each report of an adverse experience it receives. It then classifies the relationship between the veterinary medicine or agricultural chemical product and the adverse experience. This classification may cause the APVMA to confirm the registration of a product as safe and effective, or to request some changes to how the product is manufactured, packaged or used (and corresponding changes to label instructions and warnings). On rare occasions, the APVMA may cancel the registration of the product and remove it from the market.
Reports of adverse experiences are closely monitored by the APVMA. Annual summaries of adverse experience reports (from 2015 to present) are available on data.gov.au.