This content is current only at the time of printing. This document was printed on 7 September 2020. A current copy is located at http://www.gitygostar.com/node/244
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Who can report an adverse experience?
Anyone can report an adverse experience to the AERP. This includes veterinarians, animal owners, farmers, gardeners, agronomists, health workers, state and territory authorities or members of the public.
The APVMA receives reports about adverse experiences from three main sources:
- veterinarians and the general public (including animal owners, farmers and other chemical users)—they can voluntarily report any adverse experiences to both the APVMA and the product registration holder
- state agencies—they are encouraged to report any adverse experience reports they receive that are within our jurisdiction. This also enables us to inform the relevant state authority of any information that we become aware of that falls within state jurisdiction (such as state control-of-use issues)
- registration and permit holders—they are obliged to report to us about any adverse experiences they become aware of involving their product(s). This is one of the ways product registration holders can meet certain legislative obligations under section 161 of the Agvet Code.
Obligation to provide any adverse information in respect to a registered product
Registration holders of veterinary medicines and agricultural chemicals have a legal obligation to report any adverse events from the use of their registered product to the APVMA.
Under section 161 of the Agvet Code, registration holders must provide the APVMA with any new information that comes to their attention. This may include information on adverse human health effects; harm to animals; damage to plants, property or the environment; or lack of efficacy when the products are used according to label directions. The registration holder reporting component of the AERP for agricultural chemicals is one method by which registration holders can meet certain legislative obligations of section 161 of the Agvet Code.
Information provided under section 161 (unless provided in relation to a permit) is eligible for limits on use of information.