Australia | Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020

Title of document
Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020

Description
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.  Australia does not currently have the infrastructure to facilitate medicine tracking. The introduction of the new standard will occur independently from the broader considerations needed before Australia determines which track and trace system is appropriate for our medicine supply chain.  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  https://consultations.health.gov.au/medicines-regulation-division/consultation-tgo106-data-matrix-codes-on-medicines/ . 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.

Notifying member: Australia

Notification: G/TBT/N/AUS/126

Objective tag
Consumer information, labelling; Harmonization

Objective
The objectives of the new standard are to: provide clarity on technical requirements for adopters of data matrix codes and medicine serialisation provide a foundation to support all systems relying on the codes provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability.

Agency responsible
Therapeutic Goods Administration, Department of Health

Timing:

• Submission: 09/11/2020
• Reception: 09/11/2020
• Distribution: 09/11/2020
• Final date for comments: 08/01/2021
• Proposed date of adoption: N/A