Serialisation and data matrix codes on medicines
A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January 2023.
The Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 does not mandate the use of data matrix codes or serialisation of medicines but sets out requirements if medicine sponsors choose to do either of these.
TGO 106 aligns with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability.
New requirements for medicines with data matrix codes or serialisation
Medicines released for supply from 1 January 2023 must comply with the requirements of TGO 106 if they:
The guidance for TGO 106 includes information on how to comply with the standard.
What is medicine serialisation?
Serialisation is the unique identification of each unit of a medicine, allowing a unit to be identified distinctly within its batch. This typically is achieved by applying a serial number to the unit. See guidance for TGO 106 for more information.
What are data matrix codes?
A data matrix code is a type of two-dimensional code that can be read by a 2D scanner. It is a small square or rectangle with two solid edges, two dotted edges and pixelated light and dark areas within the matrix. There are no shapes within the matrix.
This format captures more and different types of information within a smaller space than traditional linear barcodes.
For medicines that must comply with TGO 106, a data matrix code must be formatted as a GS1 DataMatrix as set out in the GS1 General Specifications.
Benefits of data matrix codes
The beneficial features of data matrix codes include:
- large data carrying capacity
- built-in error correction providing reliability and readability in situations where the label is damaged or if the pack is irregularly shaped
- easily printed at high production speeds, such as those found in medicine manufacturing environments.
Data matrix codes can be a vehicle for data needed in electronic health systems and ‘track and trace’ systems. Adoption of these codes, in combination with suitable systems, can bring future opportunities and benefits to Australian health care.
Differences between codes
QR codes are another type of two-dimensional code with some similarities in appearance to data matrix codes. However, unlike data matrix codes, QR codes have large squares in the corners of the code.