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Inside the Spray Tank: surviving the screen

June 2009

Welcome back to Inside the Spray Tank – an informal ‘slice of life’ view of ACVM operations.

This is the first in a series of blogs offering an internal perspective on procedures/issues to give you some background to our decision making. ‘Surviving the screen’ has been written by Andrew Pearson, who is currently our MRL advisor but also has experience with most of the application types we receive. (photo: Andrew Pearson)

The May News and Views provides an article on what makes a complete application. While a number of the points may seem pedantic, they all have a value in ensuring that we can access the data we need quickly and thus reduce the time taken to raise a conclusion on the risks, and also reduce the chance that your application will be rejected at initial screen and/or declined during appraisal.

I’ll attempt to expand on this by briefly covering the key points we look at to see whether an application is suitable to pass the initial screen (formerly known as pre-screen).

Generally, the first time technical advisors see an application is through the initial screen. At this point all of your submission will have been broken up by one of the operations advisors, usually your allocated client manager, so that the crux of the application, data assessment reports, summaries, covering letter, labels and PDS are in a product file with any supporting dossiers attached for reference.

A clear purpose for the application

The purpose of undertaking an initial screen is to filter out any applications that are deficient. This is why a comprehensive covering letter is so important. If the advisors can’t clearly identify what the purpose of the application is, then we can’t judge that the data requirements have been met and/or any waivers are suitable. The quickest way to have an application rejected at the screen is to have an ambiguous covering letter on the assumption we will make a judgment on the purpose of the application for you.

Meeting all the data requirements

Once it’s established that you’re making a specific type of application, it’s possible to consider if the data requirements are met. These, of course, differ with each class of agricultural compound and with the application type. If you state what you’ve provided in support of the application in the covering letter, such as specific information waivers or data assessments, it aids greatly in clarifying the application is complete. Going back to my earlier point about clearly identifying the purpose -- if you’ve submitted all of the data but intend for us to complete specific data assessment reports prior to actual consideration, this needs to be very clear or your application will be considered deficient and not accepted because these reports are absent.

Addressing non-conformances

If all of the data appears to be present, the conclusions of the data assessments are checked to see if the reviewer supports the application and to determine if any conformance issues noted have been addressed. If the data assessor notes conformance issues, we expect every issue to be addressed prior to the application being submitted either through clarification or arguments presented in the covering letter or, if it is a significant issue, through the provision of an information waiver.

Defending deficiencies

If you are unable to meet certain data requirements for your proposed application, then each deficiency needs to be defended with an argument. If the deficiency is significant, we expect it to be submitted in the form of an information waiver. Generally it is preferable that these are submitted prior to the full application -- if they are submitted together the application runs the chance of being held up while the waiver is appraised.

Submitting the label and PDS

Finally, a completed PDS and label go without saying. There may be PDS entries that you are unable to complete -- for example, you’re not expected to know what ACVM reference number you’ll be assigned. However, in saying that, it is expected that everything that is recorded matches what is in the data assessments, and any recommended label amendments by the data assessor are made or justified as to why they may not be necessary.

This page was last updated on 18 June 2009.