Application profiling and registration pathways

The APVMA is seeking to ensure that regulatory effort and the regulatory burden imposed on those affected is always aligned with the risks associated with chemical use.

Different product types give rise to different risks and, as a result, the levels and types of assessment vary. Generally, lower risk products require reduced levels of assessment, currently achieved through the use of application categories that are graduated based on the level of risk. However even for those applications where the risks are well understood, some regulatory effort and consideration is given before that application can be finalised.

In order to align regulatory effort to the risks associated with the registration of agricultural and veterinary chemicals, the APVMA is looking at opportunities to reduce the regulatory burden for certain applications that meet relevant criteria. Initially, applications for active constituent approvals, product registrations and variations are included in the scope. At a later date, applications for permits and manufacturing licences may be incorporated into the review.

This is being achieved through firstly profiling applications to identify those types of applications where a lower level of regulatory intervention would be appropriate and secondly offering alternative pathways for registration and approval of these.

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