You are here
Assessed listed medicines evidence guidelines
Version 1.1, August 2018
8. Application dossier requirements
The application dossier for listed medicines is based on a simplified version of the CTD structure. This structure allows evaluators to quickly and efficiently locate specific information.
All application dossiers must consist of the following components:
- Application form
- CTD Module 1: Administrative information for assessed listed medicines including cover letter.
L(A)2 and L(A)3 applications must also include any additional documents specified in the Mandatory requirements for an assessed listed medicine application to pass preliminary assessment.
The dossier must adhere to the TGA's general dossier requirements and the CTD module-specific guidelines.
- The definition of a dossier is: "A collection of files and documents that contains data (administrative, quality, nonclinical and clinical) relating to a therapeutic good."