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The Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application. When an applicant lodges a PPF, the first phase of the prescription medicines registration process begins.
In February 2023 the TGA made updates to the PPF to include a real world evidence (RWE) usage declaration and the sponsor’s preferred tradename to be published on the TGA’s website whilst the application is under evaluation. The TGA also removed the request for an estimation of hard copy pages that would be included in the submission.
Applicants must ensure they use the most recent version of the PPF.
For detailed instructions for completing the PPF, see: Information for applicants completing a pre-submission planning form.
Our preference is for you to submit a Microsoft Word version of the PPF as this will assist with our management of your application.