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.
|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|
||Prescription Medicines Authorisation Branch/Scientific Evaluation Branch||02/2018|