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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