G/TBT/N/AUS/126  
9 November 2020  
(20-7959) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Therapeutic Goods Administration, Department of Health  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if d ifferent from above:   
Department of Foreign Affairs and Trade  
Email: tbt.enquiry@dfat.gov.au  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medicines; 
PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified 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  
6. Description of content:  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 en sure 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 G/TBT/N/AUS/126  
 
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  standard will be implemented in January 2021, with a delayed commencement period (up 
to 2 years) to allow sufficient time for sponsors currently ap plying data matrix codes 
and/or serialising to comply with the standard.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the new standard are to:  
• provide clarity on technical requirements for adopte rs 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.  
; Consumer inf ormation, labelling; Harmonization  
8. Relevant documents:   
The proposed standard and consultation documents are available here: 
https://consultations.health.gov.au/medicines -regulation -division/consultation -tgo106 -
data-matrix -codes -on-medicines/ . The p roposed standard will be updated in 
consideration of the consultation feedback before it is implemented.  
9. Proposed date of adoption:  January 2021  
Proposed date of entry into force:  An updated version of the standard is likely to be 
implemented in January 2021 with a delayed commencement period (up to 2 years).  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The proposed standard and consultation documents are available here: 
https://consultations.health.gov.au/medicines -regulation -division/consultation -tgo106 -
data-matrix -codes -on-medicines/ . 
https://consultations.health.gov.au/medicines -regulation -division/consultation -tgo106 -
data-matrix -codes -on-medicines/