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Use this form to propose a name for biological substances to be included in products regulated under the Biologicals Framework, i.e. human and living animal cells and tissues. The Biologicals Framework covers blood, blood components, tissue & cellular products, tissue & cell based derivatives and other emerging biological therapies.
Do not use this form to propose a name for a biological substance to be used in complementary medicines, vaccines, peptides, monoclonal antibodies and other recombinant products. Please refer to Proposed Approved Biological Name (ABN) application form to propose a name for a biological substance. Refer to the Australian Regulatory Guidelines for Biologicals (ARGB) for information on the regulation of Biologicals.
Refer to Ingredient naming requirements and categorisation for further detail.
The information provided in this form will be used to determine the name and definition of the substance. The use of an ingredient is approved by other areas of the TGA.
Form
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