Making an application for pre-application assistance

You can apply for pre-application assistance through the Online Services Portal. You do not need an account to make an application.

The APVMA Online Services Portal will guide you through a series of questions to identify what pre-application assistance tier you need. Your application will be assigned a tier depending on its complexity and the amount of work required for the APVMA to provide a response. The tier determines the relevant application fee. 

A separate application is required for each agricultural or veterinary chemical product or active constituent. 

In the application you can:

  • outline the purpose of your pre-application assistance application and identify specific questions or issues for advice
  • upload supporting information, such as a proposed label, directions for use, or any other reference material
  • choose to receive your pre-application assistance in writing, at a meeting with the APVMA, or both. 

To get the most out of your request for pre-application assistance you should provide as much information as possible in your application.

What to expect when you submit the application online

1. Online confirmation of your application

When you finalise your application, you will see a message confirming that your application has been received by the APVMA. You will then be directed to pay the application fee.

After you have paid the application fee you will see a screen with 2 links – ‘Review your submission’ and ‘Copy of your receipt’. You should open and print or save both PDF files as you will need the identification number and details for future reference.

2. Contact from the APVMA about your application

The APVMA will:

  • Provide written confirmation of receipt of your application
  • Allocate a case manager who will be your main point of contact throughout the process
  • Verify all components of your application, including whether the appropriate tier has been selected
  • Contact you to seek clarification on your application, if required
  • Arrange a meeting time if a meeting is requested

3. Pre-application assistance

Written response

The APVMA will provide a written response to your pre-application assistance application.

Meeting

Your case manager will arrange a meeting if you have requested one in your application. The APVMA may request a meeting if it considers discussion is necessary to prepare written advice, particularly regarding the suitability of technical data. Meetings will generally last for one hour.

Meetings can be held by videoconference (preferred), teleconference, or in person at the APVMA Office in Canberra ACT or Armidale NSW. The APVMA uses Microsoft Teams for online meetings.

You will be provided with the written response to your application after your meeting. 

Please note that formal meeting minutes are not taken by the APVMA.

4. Clarification and further assistance

You can contact your case manager to request clarification of the pre-application assistance provided by the APVMA.

If you require further assistance, you will need to apply for more pre-application assistance. 

Applicants are reminded to provide as much detail as possible in their applications so that the APVMA can provide a thorough response.

5.   Providing feedback

The APVMA welcomes feedback on its pre-application assistance processes.

You will receive a link to a feedback form with your pre-application assistance. Your feedback will assist us to improve the pre-application assistance process.

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