Key dates in Australia:
1st January 2023 – Medicines subject to TGO 106 that are released for supply from 1 January 2023 must comply with TGO 106.
Introduction
TGO 106 guidance by the Australian government department of Health provides guidance to sponsors and manufacturers supplying medicines in Australia. Even though serialization and use of data matrix codes at this time continues to be optional, we can definitely see that Australia is seeking to organize the standards before making them mandatory to introduce slow and steady changes without disrupting the supply chain industry.
As the issue of counterfeit drugs continues to plague the Supply Chain industry, it is not a matter of if but a matter of when these regulations will go into effect as governments throughout the world seek to implement stricter measures to battle the distribution of counterfeit drugs but still ensuring global interoperability and standards for legitimate and essential drug movement between countries.
The noticeable changes include the nomenclature of the saleable “primary pack” and “primary packaging” as per the Therapeutic Goods Order (TGO) which goes into effect on January 1, 2023.
Primary Pack – “the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.”
Primary packaging – “Primary packaging, as used in GS1 and GMP guidance, is the packaging which directly contacts the medicine” (injection vial, tablet blister and so forth).
This was based on the health government’s efforts after consolidating the feedback it received. The government invited feedback in response to its TGO 106 and received 43 submissions. The Therapeutic Goods Order only applies to medicines that are already serialized (each unit bearing a unique identifier to be identified distinctly within its batch) and include a data matrix code (two-dimensional code readable by a 2D scanner) which in turn encodes the GTIN (global trade item number used by companies to uniquely identify all of their trade items).
Part 2 of TGO 106 outlines the requirements for medicines subject to TGO 106. Medicines that are serialized are subject to the requirements outlined in Section 8, 9 and 10 of TGO 106. Medicines that are not serialized but have a data matrix code that contains a GTIN must comply with Sections 9 and 10. Dispensed or extemporaneously compounded medicines as outlined in subsection 7(2) and 7(3) that are serialized using a method other than the application of data matrix codes are not subject to the requirements in Section 8. If these medicines have a data matrix code with a GTIN for another purpose (that is, the code does not contain the serial number) then they are subject to the requirements in Sections 9 and 10. The intention is that if these medicines are serialized then you do not have to add a data matrix code. However, application of data matrix codes as outlined in TGO 106 is the recommended method for serializing medicines.
Product Identification
If a medicine primary pack is serialized, a Data Matrix must be applied with the following data elements:
- Global Trade Item Number (GTIN)
- Batch or Lot Number
- Expiry Date
- Randomized Serial Number
If a medicine container or single unit packaging within a container is serialized, the following data elements must be encoded in the data matrix code:
- Global Trade Item Number (GTIN)
- Serial Number
If a medicine is not serialized, there are no requirements for additional data elements to be included within the Data Matrix. Other data elements can be included subject to GS1 General Specifications and TGO 106.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Australia pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
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