We asked for feedback on our draft Therapeutic Goods Order 106 – Standard for Serialisation and Data Matrix Codes (TGO 106) because we want to make sure the standard is fit for purpose and provides clarity for early adopters of medicine serialisation and data matrix codes on medicines supplied in Australia.
We received 43 submissions in response to the consultation. Respondents provided a range of suggestions to improve the new Order and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. We appreciate all the feedback we received.
We did
We considered all feedback received and made changes to the standard and guidance. We implemented the updated standard in March 2021. For more information, see new standard for serialisation and data matrix codes on medicines.
Changes we made in consideration of feedback included:
View submitted responses where consent has been given to publish the response.
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain.
To make sure the standard is clear, meaningful and fit for purpose. We are seeking feedback on its suitability and potential impacts.
Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020
Guidance for TGO 106 Medicines—Standard for Serialisation and Data Matrix Codes
This consultation paper gives further details about data matrix codes and the standard.
Consultation paper - Data matrix codes and serialisation of medicines
Data matrix codes are an important first step towards a medicine traceability system. Better healthcare - a vision for the use of data matrix codes and medicines traceability explores the potential benefits for our Australian health care system.
This consultation has now closed. Thank you to all who provided their feedback.
We will be reviewing and analysing all feedback received and updating the results on this page. Watch this space!
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