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Prescription medicines regulatory decisions and notices (archived)
- Australian eCTD submissions
13 January 2016: An interface between applicants (or manufacturers) and the TGA, the Australian eCTD format facilitates the validation, reviewing and electronic processing of applications
- Brochure: Pre-submission phase: Type A and D applications
29 June 2016: The pre-submission pilot will test the effectiveness of removing the need to provide a 'Module 2 or equivalent' with your Pre-submission Planning Form (PPF)
- Periodic Safety Update Reports (PSURs) for well-established active substances or the registration of a generic
11 February 2010: Notice about the need for the submission of PSURs that have been required for products in certain categories