What happens once I submit my overseas/international assessment?

Our initial assessment of the data

We will make an initial evaluation of the international or other national assessment to check that it:

  • is relevant to the active constituent or product intended for approval or registration in Australia – including its identity and use pattern
  • fulfils Australian regulatory (data) requirements
  • is consistent with Australian technical policy
  • uses contemporary scientific methodologies for hazard, exposure and risk assessments
  • is supported by all underlying data contains an adequate level of reporting detail.

If we find the assessment fit for purpose, it will be used as a basis for our Australian assessment.

If an international assessment is expected to become available after we’ve started our evaluation of an application, you may consider using the timeshift arrangements (Item 27 application). You should discuss this with us at pre-application assistance (PAA).

How we use the assessment

We will use the international or other national assessment to inform our regulatory decision, and not simply adopt the conclusions of that international assessment. Each international assessment must be fit-for-purpose and supported by studies that fulfil our regulatory (data) requirements.

We may seek data supplemental to that used in overseas assessments to meet specific legislative requirements and to enable us to fully consider the risk for Australian environmental conditions and use patterns.

In all cases, we must be satisfied that the proposed use of a product is safe and effective, which is achieved through a scientific assessment process. The use of an international assessment does not remove the obligation of applicants to submit certain studies, data or information nor does it remove our responsibility to undertake an independent scientific evaluation.

Additional data or studies generated since completion of the original studies contained in an international assessment that could reasonably be expected to be submitted under s 160A of the Agvet Code must also be submitted. Depending on the age of the international assessment, new data could be generated after its completion. We expect applicants to provide any new published or unpublished data relevant to the application.

We do not expect data to be submitted that would not already be required to support an active constituent or product application.

Your feedback will be submitted to the APVMA anonymously. If you require a response, please contact us.