New Australian pharmaceutical labelling requirements

Following a lengthy and thorough process carried out by the Therapeutic Goods Administration (TGA), a new therapeutic goods order related to the labelling requirements for prescription medicines has now been released. The orders commences as of 31 August 2016, allowing for transitional compliance until September 1 2020.

As Section 6 of TG091 includes the requirement for ‘machine readable code’ in the form of a GS1 Global Trade Item Number contained within a GS1 barcode, please see below for some of the basic information to assist in your understanding of this.

Global Trade Item Number (GTIN)

  • The Global Trade Item Number (GTIN) is a globally defined standard used to uniquely identify its specific ‘trade item’ or product. For Pharmaceuticals this means that a GTIN can be used to identify different product variants, differentiating between strengths, dose forms, packs sizes and the different supplier brands of products.
  • Each GTIN is globally unique thus helping ensure a specific pharmaceutical product/item can be unambiguously identified throughout its journey from manufacturer to patient within master data, transactional data and event data – providing a common language when parties need to collect or communicate about the item/product across that journey.
  • Although products may have the same ingredients, same strength, same dose form and be the same pack size, if they are manufactured/sponsored by different companies they must have a different GTIN to identify the unique products which most often have been manufactured in different  places, using different ingredients – the GTIN help enable traceability.
  • Most commonly is encoded within a barcode, but can also be encoded within RFID.
  • Where there is a need to have both a barcode to suit linear scanning (using EAN-13) and a barcode to provide greater levels of data about the product such as batch, expiry, serial number (using GS1 DataMatrix) it is important that the barcodes on the same product contain the same GTIN.
  • Where the product has multiple packaging levels, the GTIN and barcode at each different packaging level must be different to differentiate between them (ie a box of 5 x 20ml ampules must have a different GTIN to the individual ampule, a sleeve of 10 packs of tablets must be different to the cardboard pack and be different to individual unit dose)
  • GTIN may sometimes be referred to as EAN (European Article Number) in some systems

We will continue to provide further articles to assist suppliers and manufacturers, however if you have any questions regarding the machine readable code elements of the orders contact the Healthcare Team.

The new orders can be sourced from the TGA website – Labelling and Packaging.