Guidance on biological standards

Last updated

13 December 2022

Below are links to guidance on each of the product-specific standards to assist you in ensuring your products conform with the relevant standards.

ARGB Appendix 10: Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products
ARGB Appendix 11: Guidance on Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
ARGB Appendix 12: Guidance on Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Screening Requirements) (TGO 108) Order 2021
ARGB Appendix 13: Guidance on Therapeutic Goods (Standards for Biological - General and Specific Requirements) (TGO 109) Order 2021

This webpage on the TGA website was printed on 10 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 Printed content may be out of date.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/guidance-biological-standards

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Guidance on biological standards

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