The recently announced 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 Theraupetic Goods Order only applies to to medicines that are already serialized (each unit bearing a unique identifierto 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).
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