Table of Contents
Discover Track & Trace Requirements for Australia
Till January 2023, the serialization and use of data matrix are optional for manufacturers and sponsors supplying medicines in Australia. The Therapeutic Goods Order – Standard for labels of prescription and related medicines (TGO) No.91 and TGO No.92 documented the requirements that are consistent with the National Medicines Policy which aims to meet medication and related service needs, so that both optimal health outcomes and economic objectives are achieved. In March 2021, TGO No.106 was published, aligning with global standards and providing consistency for sponsors and manufacturers that operate in multiple jurisdictions in order to ensure global interoperability. The document clearly states the requirements. Products that are covered by the regulation for serialization are the serialized (according to sections 8, 9, and 10 of TGO 106) and these included a data matrix code with encoded GTIN (according to sections 9 and 10 of TGO 106). TGO No.106 commences on 1 January 2023.
The four central objectives set out in the policy are:
- timely access to the medicines that Australians need, at a cost individuals and the community can afford;
- medicines meeting appropriate standards of quality, safety and efficacy;
- quality use of medicines;
- maintaining a responsible and viable medicines industry.
The barcode requirements are as follow: GTIN, Expiry date, Batch/Lot, Serial Number. The document pointed out some recommendation to the adopters:
- serial numbers to contain only numerical digits,
- exclude letters that may cause confusion with similarly shaped characters, for example 0, and O
- avoid mixtures of upper- and lower-case letters
- avoid symbols if possible
*If a medicine container or single unit packaging within a container is serialized, the GTIN and Serial Number must be encoded in the data matrix code:
**If a medicine is not serialised, there are no requirements for additional data elements to be included within the DataMatrix.
Of course, there is a list of products that go under exception:
- Export medicines
- Blood or blood product
- Medicines supplied under special circumstances
- Medicines imported for use by immediate family