Applying for pre-application assistance

Making an application for pre-application assistance

• Applications for pre-application assistance (PAA) are undertaken online through the APVMA Online Services Portal. An account is not required to lodge a PAA application.
• Under the registration and permits tab, select 'decision tree'.
• A separate application is required per product or active constituent.
• The Online Services Portal guides you through a series of questions to identify what type of PAA you need – tier one, two or three.
• Answer each question as accurately as possible.
• Supporting information can be uploaded with your request, such as a proposed label, directions for use, or any other reference material.
• The application form gives people the opportunity to outline the purpose of the PAA request and to identify specific questions or issues.
• You can choose to receive PAA in writing or, (for tier 2 or 3 PAAs), via a meeting held by videoconference, teleconference, or in person at the APVMA office.
• The fee is payable at the time of making the application.
• You may be entitled to a rebate of the fee.
• To get the most out of your PAA provide as much detailed information as possible.

Applications for pre-application assistance are made through the APVMA Online Services Portal.

What to expect when you submit the application online

1. Online confirmation of your application

When: Immediately, as an online confirmation message.

• When you click on ‘complete’ to finalise your online application you will see a message confirming that your application has been received.
• After you make your payment you will see a screen with two links – ‘Review your submission’ and ‘Copy of your receipt’. Please open and print or save these PDF files as you will need the identification number and details for future reference.

Keep a copy of your receipt and note the identification number – you will need these for future reference.

2. Contact from the APVMA about your application

When: In the first 10 days.

We 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
• call to seek clarification on your application, if required
• arrange a meeting time where a videoconference, teleconference or face-to-face meeting is proposed.

A case manager is assigned to every PAA application and is your point of contact for the life of the application.

3. Providing the assistance

When: As per specified timeframes.

Written assistance

• Where there is no meeting request, you will receive written assistance within the specified timeframe relevant to the required tier of assistance. Timeframes commence from the date of receipt of your application.

Meeting

• If you have requested a meeting (videoconference, teleconference, or face-to-face) for a tier 2 or 3 PAA a mutually suitable date and time will be arranged.
• If the APVMA is unable to find a date suitable for you within the stated timeframe, a new timeframe will be negotiated.
• Meetings will generally last for one hour.
• Following the meeting, you will be provided with draft written advice. If you have comments arising from this written advice, the APVMA will address these and issue a final copy of the written assistance. Please note that formal meeting minutes are not taken by the APVMA.

The APVMA aims to finalise all written pre-application assistance requests within specified tiered timeframes. Where meetings or teleconferences are required, finalisation will depend on the time taken to arrange and conduct the meeting and coordinate endorsement of the minutes.

4. Clarification and further assistance

• You can contact your case manager to request clarification of advice after reviewing the pre-application assistance.
• For advice on substantial additional or new questions, you will need to apply for further pre-application assistance.
• If you are seeking clarification or development of a project plan more than 12 months after the PAA advice was issued, you will, in most cases, need to submit a new PAA application.

New and substantial additional questions will require a new application for pre-application assistance.

5.   Opportunity to provide feedback

• The APVMA welcomes feedback on its pre-application assistance service.
• You will receive a link to a feedback form when your request is finalised to give you an opportunity to tell us about your experience.
• Feedback assists us with continual improvement of the pre-application assistance process.

You can withdraw a pre-application assistance request at any time by emailing enquiries@apvma.gov.au and quoting the identification number of the request.