This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/1143
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Recategorising an application item or module level
Applications made under the Agvet Code may require differing levels of assessment for the Australian Pesticides and Veterinary Medicines Authority (APVMA) to be satisfied of the relevant criteria set out in the Agvet Code. When a person makes an application under the Agvet Code it is categorised as requiring assessment in line with a particular item of the table in Part 2 of Schedule 6 to the Agvet Code Regulations and where required it is assigned particular modules, levels or types mentioned in Schedule 7 of the Agvet Code Regulations. This recategorisation is based on the level of assessment required.
At any time after preliminary assessment, the APVMA may determine to recategorise your application to the appropriate item or assessment module levels for an application.
We must give you notice if we recategorise an application. As a consequence of the recategorisation, different application fees and assessment timeframes may apply to the recategorised application. The fee structure and assessment timeframes in the Agvet Code Regulations reflects these differing levels of assessment.
We will only recategorise your application to ensure that the correct:
- level of assessment, and associated assessment period is applied
- fees are charged.
We will recategorise your application only where the information provided by you is sufficient for us to assess the recategorised application.
We will not recategorise your application where further information would need to be provided by you for us to assess the recategorised application. In this situation we must assess the application made by you and make the appropriate decision in relation to your application.
We will not recategorise your application where you have provided all of the relevant information required to assess an application under the nominated item and during the course of the evaluation we determine that we cannot be satisfied that the application meets the statutory requirements, but we identify that if further data was to be provided and the application recategorised the approval or registration may be granted. In these circumstances, we must assess the application made and make the appropriate decision in relation to your application.
Any recategorisation of an application made by the APVMA must be consistent with the Agvet Code and the Agvet Code Regulations.