Mandatory requirements for an effective application

Overview

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.

Scope

These requirements apply to applications lodged with the TGA:

• 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.