This content is current only at the time of printing. This document was printed on 18 September 2020. A current copy is located at http://www.xlg888.com/node/108
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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 pre-application assistance application.
- Under the registration and permits tab, select 'decision tree'.
- A separate application is required per product or active constituent.
- The online system guides you through a series of questions to identify what type of pre-application assistance 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 pre-application assistance request and to identify specific questions or issues.
- You can choose to receive pre-application assistance in writing, via a videoconference or 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 first 10 days.
- 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.
- 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.
- If you have requested a videoconference, teleconference or face-to-face meeting these are arranged by agreement of a mutually suitable date and time.
- 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.
- Prior to? the meeting, you may receive a draft copy of the written advice? for discussion during the meeting. 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 but applicants are welcome to submit their own minutes after the meeting for consideration in the final written advice.
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.
Tier of assistance
Tier 1 – written response
Tier 1 – with meeting
Tier 2 – written response or meeting
Tier 3 – written response or meeting
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/new questions you will need to re-apply for further pre-application assistance.
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 feedback form when your request is finalised to give you an opportunity to tell us about your experience.
- You can seek further clarification on the assistance provided at any time.
- 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 email@example.com and quoting the identification number of the request.