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Mandatory requirements for an effective application

Applicable for applications lodged from 9 February 2018

21 February 2018

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This guidance describes the information that must be submitted to the TGA for prescription medicine applications to be considered effective and proceed to evaluation. To the extent that the Pre-submission Planning Form (PPF) is a reflection of the dossier to be submitted, these requirements apply equally to Milestone 1 and Milestone 2 of the registration process.

Appendix A - Specific mandatory requirements describes the common application issues and deficiencies we have identified.


These requirements apply to applications lodged with the TGA from 9 February 2018:

  • to register a new prescription medicine (excluding applications to register an Additional Trade Name and applications to which Regulation 16G applies)
  • to vary the register entry for a prescription medicine that involves clinical, nonclinical, or bioequivalence data.

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