Category
Standard
Organisation
ID
F2021L01325
Type
Standard
Access
Open
Status
Active
Created
Sep-21
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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