This content is current only at the time of printing. This document was printed on 25 October 2016. A current copy is located at http://apvma.gov.au/node/10916
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New scientific information may emerge after an active constituent has been approved or a product has been registered, which suggests a change in the risks to human health, the environment, animal or crop safety, or trade.
The APVMA may undertake a formal legislative review (or reconsideration) to scientifically reassess the risks and determine whether regulatory changes are necessary to ensure that the chemical or veterinary medicine can continue to be used safely and effectively. These changes may include modifying the way chemicals are used or, if risks cannot not be managed, removing chemicals from the market.
The reconsideration process incorporates legislative, administrative and scientific elements that contribute to the final decision to affirm, vary, suspend or cancel an approval or registration. As a result, formal legislative reconsiderations can be complex, have high resource requirements and long timeframes—under current legislation, a reconsideration must be completed within a maximum timeframe of 57 months. For these reasons, the APVMA seeks to address regulatory issues pragmatically by exploring alternative regulatory and non-regulatory pathways before deciding to conduct a review.
The formal reconsideration process is initiated when new scientific information raises concerns relating to the safety or effectiveness of the pesticide or veterinary medicine.
The formal legislative process commences when the CEO decides it is necessary to undertake a reconsideration and issues a legal notice to holders placing their approvals and registrations under review.
It is a legal requirement for holders to comply with this notice and there are penalties for not providing requisite information within a specified timeframe. Holders are provided a work plan for the reconsideration, which sets out the key milestones and legislative timeframe within which a decision on the approval or registration must be made by the CEO.
In addition to data submitted to the APVMA by holders, the APVMA considers all relevant published data and assessment reports.
See a list of the chemicals nominated and prioritised for review.