Australia TGA Publishes Guidance on Standards for Biologicals for Labelling Requirements

The Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 107 to provide a detailed explanation for manufacturers, sponsors and those who provide biologicals and human cell and tissue (HCT) materials, in November 2021. 

“TGO No. 87 General requirements for the labelling of biologicals (TGO 87) 2011” is superseded by TGO 107. 

TGO 107 applies to all biologicals and HCT materials, provided that they come within the operation of Part 3-2A of the Therapeutic Goods Act 1989 and also include starting materials, intermediates in the manufacturing process and finished therapeutic goods. 

As for the labelling requirements, Part 2 of the guidance provides relevant information such as general requirements for the labelling. For example, the information displayed on the labels must be in English, must be clearly visible and not covered or obscured and legible. 

More details can be found in “ARGB Appendix 11 – Guidance on TGO 107: Standard for Biologicals – Labelling Requirements, November 2021”:  

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