Module 1.2.1: Assessed listed medicine general application information form

27 March 2018

The Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.

Complete the form as per the instructions in the guidance for completing the application form for an assessed listed medicine on the TGA website. Please include the form in module 1.2.1 of your application dossier.

The form is divided into two parts:

Part(s) Instruction
A - Formulation details Complete one part A for each formulation in a medicine
B - Manufacturer details Complete one part B for each application

Application form

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This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.