Mandatory requirements for an effective application
Applicable for applications lodged from 9 February 2018
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.