Posted by Michael Wonder on 21 Feb 2018
Mandatory requirements for an effective application
21 February 2018 - 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 is a reflection of the dossier to be submitted, these requirements apply equally to Milestone 1 and Milestone 2 of the registration process.
