The TGA has introduced a new standard for serialisation of medicines and use of data matrix codes; the TGO 106 - Therapeutic Goods (Medicines - Standard for Serialisation and data Matrix Codes) (TGO 106) Order 2021).

The Order does not mandate the use of data matrix codes or serialisation of medicines in Australia, but is designed to put in place minimum technical requirements to ensure the effectiveness and functionality of serialisation and data matrix codes, where sponsors intend to use such technology for medicines supplied in Australia.

Please read today’s amended technical alert for more information and details, including when the requirements of the Order do and do not apply.