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The importance of the AERP
The Adverse Experience Reporting Program (AERP) collects information on how products perform after registration to ensure that they continue to be safe and effective. The AERP completes the regulatory loop to ensuring that the registration decisions we make are appropriate and that standards in chemical products are maintained. This promotes and maintains confidence in the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the National Registration Scheme for Agricultural and Veterinary Chemicals.
Under section 161 of the Agvet Code, if the holder of the registration of a chemical product becomes aware of any relevant information in relation to the product or any of its constituents, they must, as soon as they become aware of the information, give that information to the APVMA. The opportunity to further investigate the circumstances before notifying the APVMA is not made available in the Agvet Code and significant penalties apply for not complying with this requirement.
Information is relevant if it contradicts any information entered in the Record, Register or Record of Permits for the product; or shows that the product may not meet the safety criteria, the trade criteria or the efficacy criteria. This includes 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.
It is important that holders give information to the APVMA the moment that they become aware that the product may not meet the specified criteria.