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Designation checklist: for sponsor seeking Orphan Drug designation

7 August 2018

This checklist is to be used by sponsors to apply for Orphan drug designation. It is intended to assist in determining if you have provided all of the necessary information to allow the TGA to make an informed decision on the designation application.

It is your responsibility to download, complete and attach the checklist as part of the supporting documentation provided for a designation application. See TGA Business Services for more information.

How to access a pdf document

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.