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Assessed listed medicines evidence guidelines

Version 1.1, August 2018

17 August 2018

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8. Application dossier requirements

The application dossier[17] 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:

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.


Footnotes

  1. 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."

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