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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.
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.