Medicines; PHARMACEUTICAL PRODUCTS (HS 30)
Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020
The Therapeutic Goods Administration (TGA) is proposing a new standard to outline requirements for medicine serialisation and the application of data matrix codes to the labels of certain medicines supplied in Australia. The introduction of the standard is not intended to mandate the use of data matrix codes or serialisation. Instead, it sets out the technical requirements where the medicine sponsor chooses to implement either of these.
The purpose of the standard is to give clarity and certainty for adopters of data matrix codes and serialisation of medicines supplied in Australia. It is the first step in establishing requirements that support all systems relying on the codes. The requirements align, where possible, with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability.
A public consultation on the draft standard was open from July to August 2020. Respondents provided a range of suggestions to improve the new standard and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. The draft standard and consultation documents are available at
The TGA is reviewing all the submissions received and will make changes to the draft standard and guidance in consideration of this feedback. It is planned that the updated standard will be implemented in January 2021, with a delayed commencement period (up to 2 years) to allow sufficient time for sponsors currently applying data matrix codes and/or serialising to comply with the standard.