Guidance on biological standards

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