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Category
Standard
ID
F2021L00333
Type
Standard
Access
Open
Status
Active
Created
March 2021
Serialisation is the unique identification of each unit of a medicine, allowing a unit to be identified distinctly within its batch. Data matrix codes can be used to denote serialised units.

This document sets out the requirements for medicine sponsors who choose to use serialisation of medicines or data matrix codes.

Main sections:

- Preliminary information

- General requirements

- Application of a data matrix code

- Formatting etc. of a data matrix code

- Information in a data matrix code
Access Therapeutic Goods (Medicines-Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021

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