Chemical review process

The APVMA takes into account a wide range of scientific data submitted by sponsors in support of an application to approve an active constituent or to register a product containing that active constituent. 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. If this happens, the APVMA 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 and effectively.

Chemical reconsiderations are managed under the auspices of the APVMA’s Chemical Review Program, which was established in 1995. Further information on the establishment and history of this program can be found below.

Legislative basis

The APVMA has legislative powers to reconsider the approvals of active constituents, the registration of products and their labels and to require registrants to provide information.

History of the chemical review program

The history behind the Chemical Review Program.

The reconsideration process

The reconsideration process comprises legislative, administrative and scientific elements.

Timeframes for chemical reviews

The period within which the APVMA is to complete a reconsideration.

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