Category
Standard
Organisation
ID
F2021L01325
Type
Standard
Access
Open
Status
Active
Created
September 2021
This is the current version.
Biological medicines (biologicals) include vaccines, peptides and proteins. Human cell and tissue (HCT) materials are products derived from human cells and/or tissues. This document sets out the labelling requirements for biologicals and HCT materials.
Main sections:
- Preliminary
- General labelling requirements
- Labels of HCT materials
- Labels of biologicals
- Schedule 1 - Labels in relation to HCT materials
- Schedule 2 - Labels in relation to biologicals
- Information on or attached to containers and primary packs
- Information on, attached to, or supplied with containers or primary packs
Main sections:
- Preliminary
- General labelling requirements
- Labels of HCT materials
- Labels of biologicals
- Schedule 1 - Labels in relation to HCT materials
- Schedule 2 - Labels in relation to biologicals
- Information on or attached to containers and primary packs
- Information on, attached to, or supplied with containers or primary packs
Access Therapeutic Goods (Standard for Biologicals-Labelling Requirements) (TGO 107) Order 2021
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