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The purpose of this form is to guide you through the classification of biologicals and capture sufficient information about your product for us to provide advice, where this is sought.
Our advice provided is nonbinding and without prejudice, and you should seek your own independent legal advice to ensure that all of the legislative requirements are met.
If advice from us is sought, please forward the completed form to bloodandtissues@tga.gov.au.
Supporting information may need to be provided to justify the classification of your biological, including references and data generated by you.
How to access a pdf or Word 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.