This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/239
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The importance of the program
It is essential that risk management systems (such as the regulatory system we operate) have strong feedback loops to ensure that the decisions being made are appropriate and effective. Our pre-marketing evaluation processes are consistent with world’s best practice. In addition, as part of our AERP, we collect information on how products perform in the field after registration to ensure that they continue to be safe and effective. The AERP therefore completes the regulatory feedback loop to ensure that the registration decisions we make are appropriate. It also assists in promoting and maintaining public confidence in the APVMA and the National Registration Scheme for Agricultural and Veterinary Chemicals.
Section 161 of the Agvet Code requires holders to provide us with any new, relevant information they become aware of. New, relevant information on products can include adverse experience information relating to:
- human health issues
- harm to animals
- damage to plants, things or the environment
- lack of efficacy when used according to label directions.