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PPF only Pre-submission phase: Questions and answers

12 January 2017
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Yes, as per standard registration process business rules, the requisite AAN or ABN should be approved before you lodge your submission.

The online application system requires a TGA approved AAN/ABN active ingredient name in order for you to enter formulation details and successfully lodge your application.

You should liaise with the TGA Naming Committee as soon as you begin planning your submission and provide them with your planned lodgement timeframes.

Please ensure that you have given the TGA Naming Committee sufficient lead time of about one month.

Yes, it is still necessary to lodge a complete PPF. Please ensure that you meet all of the standard pre-PPF requirements in relation to orphan drug designation, literature-based submission and new proprietary and non-proprietary ingredient names. For further information, please refer to page 1 of the PPF.

Please complete the PPF which is accessible from the TGA website. The form must be completed in its entirety although there is no need to attach 'Module 2 or equivalent'. You may wish to attach additional documentation (for example, additional manufacturing site details if the existing form doesn't have enough space to include all of the proposed manufacturers).

Please note that the TGA may initiate the procurement of external evaluation resources utilising the information you provide in the PPF. Please ensure sufficient detail is provided, particularly in relation to clinical studies.

PPFs should be lodged between the 1st and 15th days of the month from the 1st February 2016. As this lodgement is an online process, this advice is applicable irrespective of whether these days fall on weekends or public holidays. We encourage applicants to lodge their PPFs at the earliest possible date within the lodgement month.
The current online application system will only allow you to select a date that is at least 2 months from the current date. Please select the earliest date and be assured that, should your application be eligible for processing, we will commence validation of the submission dossier within the specified timeframe.
The current online application system will allow you to select any date prior to the validation date. Please select the date on which you expect to lodge your complete AU specification version 3.0 eCTD dossier., This must be no later than the end of the month during which your Pre-submission Planning Form (PPF) was lodged.
The TGA will continually monitor the PPFs as they enter the system and assign a stream number (based on your proposed indication) as soon as possible. This process completes your 'submission number' and allows you to finalise your eCTD dossier.
Please submit your dossier via the usual procedure as soon as possible but no later than the end of the month in which you lodged your PPF. You may wish to refer to the Submission dossier checklist for prescription medicines for further guidance.
Yes, please ensure that your dossier is accompanied by the usual application form. Please check the TGA website for information and contact eSubmissions@tga.gov.au for a copy of the form if required.
Currently, an application will be accepted if it is either Type A (New Chemical or Biological Entity or Biosimilar) or Type D (New Generic Medicine) and is accompanied by a validated Version 3.0 eCTD dossier. As of 1 February 2017 the 'PPF only' pre-submission option will be available for all Category 1 prescription medicine application types.
No, there will be no formal Milestone 1. You should proceed to lodge your entire dossier as soon as the complete submission number is visible on eBS. This will occur once the TGA has added the relevant stream number based on your proposed indication (i.e. 'PM-yyyy-xxxxx-z-stream number'). Please contact AET.Application.Entry.Team@tga.gov.au if you experience any difficulties.
If your PPF is lodged onto the system after the 15th of the month cut-off, it may still be processed but may be batched with PPFs received during the following month's intake.
The dossiers will undergo electronic validation as well as administrative and technical screening as per the existing prescription medicines registration process. The same requirements must be met and the same decision making principles will be applied. You will be notified as to whether your dossier is 'effective' at Milestone 2, when you will receive a Notification Letter.
Yes, prior decisions made in relation to your product will not be taken into account when the eligibility criteria are applied.

You will be notified as soon as possible, if your dossier does not pass validation. Depending on the validation issues, you may be deemed to be 'not effective' or processed with the next PPF batch.

To avoid this scenario, please validate your dossiers prior to lodgement and contact the TGA immediately if you experience any difficulties (via your Case Manager at streamlinedsubmission@tga.gov.au).

Should your application be deemed to be effective, you will be issued with an Evaluation Plan at Milestone 2. An Evaluation Plan Estimator for PPF Only Submissions is available on the TGA website to facilitate your planning activities.
Please include a PDF of your PPF in Module 1.2.2. Please complete Modules 1.7.2 and 1.7.3 as you would under the existing registration process.