The Therapeutic Goods Administration (TGA) of Australia has published guidance on TGO 91 and 92 on March 23, 2021 in order to assist sponsors and producers of medicines in complying with the Australian latest labeling standards. As described in the TGA’s Amendments to TGO 91 and 92 article, the transition period for Australian medicines labeling regulation ended on August 31, 2020. Drug companies have had time to adapt to the new guidelines during the transition process and beginning September 1, 2020, all new prescription labels must comply with the new specifications.

Here is a quick explanation. The Therapeutic Goods Administration (TGA) revised labeling criteria for medicines supplied in Australia by adding two (2) new labeling orders to replace the previous Therapeutic Goods Order No. 69 – General requirements for medicines labeling (TGO 69):

The Therapeutic Goods Order No. 91 (TGO 91) for labels of prescription and related medicines, and

The Therapeutic Goods Order No. 92 (TGO 92) for labels of non-prescription medicines.

Certain provisions of the new TGOs would necessitate the revision of the labels for most of the medicines sold in Australia. They are:

  • Enhancement of the active ingredient's importance by the use of a specific placement and scale
  • Without graphics or text, the medicine's name must be a unified entity
  • Added warnings and allergen disclosures
  • Inclusion of a dispensing label room for prescription medications
  • Addition of a Critical Health Information table for non-prescription medications

As we all know, the deadline set for drug companies to adapt to the new guidelines is over. This means that the new order is now mandatory, and sponsors and manufacturers aiming for Australian market entry must comply with these labeling mandates to maintain compliance. You can contact a specialized Regulatory Services team for assistance in updating or developing medicine labels that comply with the new orders. Stay informed. Stay compliant.


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