This content is current only at the time of printing. This document was printed on 4 December 2016. A current copy is located at http://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 registered use of a veterinary medicine or agricultural chemical product when the product is used according to the approved label directions.
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.
There are two components to the AERP:
- the AERP Vet for registered veterinary medicines, and
- the AERP Ag for registered agricultural chemicals.
Anyone can report an adverse experience to the AERP—ie, 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). In some cases, the APVMA may cancel the registration of the product and remove it from the market.