Category
Supplementary Resource
Organisation
Type
Standard
Version
2
Access
Open
Status
Active
Created
Sep-21
Updated
Feb-23
The Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021 specifies the minimum requirements for labelling of biologicals and human cell and tissue (HCT) materials.
This document describes mandatory labelling requirements for biologicals and HCT materials specifically for manufacturers, sponsors and providers of these materials, and should be read in conjunction with TGO 107.
Main sections:
· About TGO 107
· Part 2 - Labelling requirements
· Annex 1: Location of requirements in dossier
This document describes mandatory labelling requirements for biologicals and HCT materials specifically for manufacturers, sponsors and providers of these materials, and should be read in conjunction with TGO 107.
Main sections:
· About TGO 107
· Part 2 - Labelling requirements
· Annex 1: Location of requirements in dossier
Access ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals – Labelling Requirements v2.0
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