Mandatory requirements for an effective application

Applicable for applications lodged from 9 February 2018

21 February 2018

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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 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.
Version history
Version Description of change Author Effective date
V1.0 First version Office of Medicines Authorisation 02/2010
V2.0 Second version: Amendments to reflect consultation outcomes, changes to business rules, inclusion of specific requirements relating to sterile products, sterile drug substances and biological and improve clarity on justifications. Office of Medicines Authorisation 05/2013
V2.1 Amendments to reflect consultation outcomes regarding GMP clearance requirements at PPF lodgement and to clarify RMP formatting requirements Office of Medicines Authorisation 04/2014
V3.0 Updated Medicines Authorisation branch 07/2015
V4.0
  • Updated to include requirements for the COR report-based process and remove Category 2 application requirements.
  • Updated to include priority registration pathway.
Prescription Medicines Authorisation Branch/Scientific Evaluation Branch 02/2018

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