Better medicine labels: get it right first time

New requirements have made Australia’s medicine labels clearer.

By Schawk! Technical Account Manager Michael De Bari.

Prescription dispensing has gone unchanged for decades in Australia. The federal Government, through its Therapeutic Goods Authority (TGA), is drastically changing the way medicines and other healthcare products are to be labelled for sale in the region. The changes are in force for labels of non-prescription medicines, and labels of prescription and related medicines.

While the Government has provided for a four-year transition period, astute brands and healthcare suppliers should start to make the changes early and in a managed way.

With the global pharmaceutical space undergoing drastic change, current and new healthcare brands will need to achieve both accuracy and efficiency with the new labelling changes. Brand owners that embrace these changes will benefit from the mandated transparency to help ensure consumer safety and patient compliance – patients who understand timing and dosage will ultimately take their prescribed treatments.

The changes regulated by the TGA are significant. They are designed to increase accessibility to information for consumers, especially when buying prescription and over-the-counter medicine, supplements, sunscreens and other healthcare products.

Major changes include:

  • Larger fonts displaying active ingredients and consistent placements.
  • Critical information in distinctive and regularly placed tables.
  • Mandatory allergen information prominently highlighted.
  • More space for dispensing labels.
  • Clearer product-storage instruction and use-by-date, batch-numbering and company-contact information.

Studies have found that packaging that reminds people about taking their medication – eg, certain antibiotics, steroids and hormone replacement – increases compliance significantly among the elderly.

Clearer labels will improve consumer safety and healthcare outcomes. The mandatory changes also provide opportunities for brands to improve shelf appeal. There are risks, however, if the changes are not executed well and are not correct the first time. Design, pre-press, on-pack and technical capabilities must evolve to assist clients with managing the required changes.

It is in the best interest of the drug manufacturers and their brands to create packaging that facilitates compliance, ensuring a positive brand experience. Affected businesses hence need to strategise early and intelligently to avoid costly and time-consuming delays in the TGA approval process. Key products in the client portfolio are being identified and created as a master to support the TGA submissions and approval, an integral part of the new legislation.

Management of regulatory-compliant labelling is a specialism and requires methodology, expertise and processes that are purpose-built for the healthcare industry. SGK has designed a four-tier solution that is modular, scalable and auditable, helping local and multinational healthcare companies to reduce costs and increase speed to market, while adhering to stringent quality compliance.

The new laws bring Australian medicine labels up to date with international best practice. The labels will help Australians make more informed choices about their medicines and use them more safely.

The new labelling rules took effect on August 31, 2016. With a four-year transition period, it is crucial for clients to get it right the first time and ahead of industry competitors.

Further reading:

For more information about the new medicine and healthcare labelling laws for Australia and New Zealand, contact Michael De Bari, Schawk! Technical Account Manager, on 02 9463 6708 or

Schawk! produces brand assets and protects brand equities to drive brand profitability. Leveraging its 60-plus years of industry leadership, Schawk! identifies and deploys scalable solutions to address a brand’s complex production and delivery needs through proven expertise in workflow, resourcing, colour management and imaging. Schawk! is part of the brand deployment group of SGK, which is a division of Matthews International Corporation (NASDAQ GSM: MATW).