Australia Outlines Major Drug Label Changes

Regulatory NewsRegulatory News | 09 August 2016 |  By 

Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find.

The changes, which will be implemented over four years beginning 31 August 2016, will be made available in Australia’s Federal Register of Legislation from 17 August 2016, along with guidance on how to apply the new labeling orders.

The four-year transition period will allow drug sponsors time to adapt to the new requirements, and from 1 September 2020 all new medicine labels will need to meet the new requirements, TGA says.


Since labeling requirements for Australian drugs have not been amended since 2014, the update will further align the labels with international best practice, TGA says.

The main changes include:

  • Active ingredients will be more prominent and easier to find
  • Most over-the-counter medicines will have a “Critical Health Information” panel to help consumers find important information about medicines
  • For prescription and non-prescription drugs, more substances that could cause an allergic reaction will need to be listed on labels, including crustacea, fish, eggs, soya, milk and tree nuts

“Prescription medicines will also have a designated space for a dispensing label,” TGA explains. “These labels are applied by the pharmacist and include important information like your name and dosage instructions. The defined space for a dispensing label space will help ensure that other information included on a carton or bottle is not covered.”
In terms of the regulations, the label requirements have been split into two new labeling orders:

  • TGO 91 - Standard for labels of prescription and related medicines
  • TGO 92 - Standard for labels of non-prescription medicines

TGA says the split was applied to better consider the different risk levels for prescription and non-prescription medicines and also to improve overall readability.

During the four-year transition period, pharmaceutical sponsors can choose to comply with the old labeling requirements under TGO 69 or the new labeling requirements under TGO 91/92 (whichever applies).

“Labels must fully comply with all requirements of either the old or the relevant new Order. A label cannot selectively comply with parts of multiple Orders,” TGA says.

After the transition period, all medicines must comply with either TGO 91 or TGO 92.

Australia's medicine labels are becoming clearer


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