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Category
Standard
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
Access Therapeutic Goods (Standard for Biologicals-Labelling Requirements) (TGO 107) Order 2021

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