Chemical review

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 history of the chemical review program shows it’s been active since the introduction of the National Registration Scheme (NRS) in 1995.

On occasion, credible new scientific information may be generated after a product has been registered that suggests the existence of previously unknown risks to human health, animal or crop safety, the environment or trade, or that suggests product ineffectiveness.

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 enacted in 2014, a reconsideration must be completed within a maximum timeframe of 57 months. For these reasons, the Australian Pesticides and Veterinary Medicines Authority (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 delegate 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.

In addition to data submitted to the APVMA by holders, the APVMA considers all relevant published data and assessment reports.

In addition to the reconsideration process, the legislative framework provides a number of regulatory mechanisms through which the APVMA can take appropriate action, including in cases of imminent harm.

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