This guidance is for manufacturers and sponsors and providers of biologicals and human cell and tissue (HCT) materials. It describes the mandatory labelling requirements set out in the Therapeutic Goods (Standard for Biologicals-Labelling Requirements) (TGO 107) Order 2021, which came into effect 30 September 2021.
Generally, Therapeutic Goods Orders (TGOs) are standards that determine the consistency of product quality, including label quality. As a provider of biologicals or HCT materials, you must comply with requirements that contribute to the quality and safety of the products, and that mitigate infectious disease risks.
TGO 107 replaces the Therapeutic Goods Order No. 87 - General requirements for the labelling of biologicals (TGO 87) 2011, which was in effect from 2011 and 'sunsetted' on 1 October 2021. Sunsetting is the process whereby legislative legislative instruments undergo automatic repeal after 10 years following their registration.
Contents
- About this guidance
- About TGO 107
- Commencement of TGO 107
- Review of TGO 107
- Part 2 - Labelling requirements
- Section 8 - General requirements
- Subsection 8(1) - Label particulars
- Subsection 8(2) - Attachment and integrity of labels
- Subsection 8(3) - Container labelling and traceability
- Section 9 - Labels of HCT materials
- Subsections 9(1) and 9(2) - Label particulars
- Section 10 - Labels of biologicals
- Subsections 10(1) and 10(2) - Label particulars
- Schedule 1 - Labels in relation to HCT materials
- Schedule 2 - Labels in relation to biologicals
- Part 1 - Information included on or attached to containers and primary packs
- Part 2 - Information supplied with primary packs
- Section 8 - General requirements
- Annex 1: Location of requirements in dossier
- Version history