This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/1006
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Ongoing compliance to ensure safety and efficacy
The APVMA has three primary post-authorisation (eg post approval or registration) programs to help ensure the ongoing safety and efficacy of agvet chemicals:
- compliance and enforcement
- reconsideration of approvals and registrations
- the Adverse Experience Reporting Program.
Compliance and enforcement
Part of our role and responsibility is to monitor and enforce compliance with the Agvet Code and other legislation we administer. We also work closely with state and territory government departments to ensure there is effective coordination and communication of compliance efforts.
We aim to maintain the integrity of the regulatory system, and focus our compliance and enforcement effort on activities that pose the greatest risk to human, plant or animal health, the environment, and trade.
In addition to conducting our own compliance campaigns, we encourage industry and the public to report the advertising and supply of unapproved active constituents ?and unregistered chemical products or the promotion of chemical products inconsistent with approved labels. Upon receipt of a report, we prioritise it for appropriate action based on the level of risk.
Higher risk reports are pursued through an enquiry that may escalate to an investigation, with a view to compliance actions. The reports assessed as representing a low to medium, or continuing risk, are primarily dealt with through warnings and negotiation to achieve compliance.
Reconsideration of approvals and registrations
Reconsideration is a process that enables us to reconsider the approval of an active constituent, registration of a chemical product or approval of a label at any time after it has been approved or registered, for example, if credible new information arises about the ongoing safety, environmental impact or effects on trade of the product.
We take a wide range of scientific information into account when estimating potential risk before we register agricultural or veterinary chemical products. Nevertheless, sometimes credible new scientific information may emerge that suggests the existence of previously unknown risks to human health, animal or crop safety, the environment or trade, or suggests product ineffectiveness. If this happens, we can initiate a reconsideration process to assess the identified risk and determine whether changes are needed to ensure that the product can continue to be used safely.
Adverse Experience Reporting Program
The Adverse Experience Reporting Program assesses and classifies reports of adverse experiences from exposure to, the use of, or the administration of a registered veterinary or agricultural chemical product sold in Australia when used according to label instructions. This program is vital for detecting uncommon conditions that are not evident and therefore not assessed during clinical or field trials for the initial APVMA registration of a product. It is also used for tracking the incidence of known adverse experiences from some products (particularly veterinary medicines).