New Standard Therapeutic Goods Order 106 – Data Matrix codes and Serialisation of Medicines
A new standard Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 has been registered on the Federal Register of Legislation and will commence on 1 January 2023.
TGO 106 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. Medicines released from supply from 1 January 2023 must comply with the requirements of TGO 106 if they:
- are serialised
- include a data matrix code that encodes a Global Trade Item Number (GTIN).
In a submission to the TGA last year, SHPA supported the development of Therapeutic Goods Order 106 (TGO 106) regarding data matrix codes and serialisation of medicines for the pharmaceutical industry sector, and recognised this as an important step towards establishing the appropriate parameters and specifications for serialisation and Data Matrix codes for medicine products.
After the consultation period the TGA made a number of changes to TGO 106 and the guidance including:
- extending the delayed commencement period to 1 January 2023 to allow sufficient time for medicine manufacturers and sponsors to comply with the standard
- reducing requirements to allow sponsors to use data matrix codes to identify medicines without a serial number where serialisation is not required (medicines that are not serialised will not need to include additional data elements in a data matrix)
- restructuring the standard to streamline and clarify requirements for medicines that are serialised versus medicines that are not serialised but have a data matrix code that contains a GTIN
- updating the guidance to clarify requirements for the primary pack and the information that needs to be included in a data matrix code.
SHPA noted in our submission that the use of data matrix codes and improved traceability will allow hospitals to:
- identify patients who have been administered or dispensed a recalled medicine
- reduce wastage by assisting with inventory management to reduce incidence of expired medicines and wastage in hospitals
- assist health systems, hospital networks and hospitals to have oversight of and manage crucial stock shortages, determining where stock is available throughout Australia, a benefit leading to increased efficiency and cost-effectiveness.