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Proposal for a new Approved Cell & Tissue Name (ACN) application form

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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.

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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.

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This webpage on the TGA website was printed on 21 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/forms/proposal-new-approved-cell-tissue-name-acn-application-form

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