Medicine labels: TGO 91 and TGO 92. What’s the impact?

^{Posted on September 5, 2016}

Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements:Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92)

The creation of separate orders for prescription and non-prescription medicines was implemented to reflect how the products are used and ensure adequate information is available for the safe use of products.

Some key changes introduced in the new TGOs will require that the labels for the majority of products supplied in Australia are revised. These include:Increased prominence of the active ingredient with specified placement and sizeMedicine name must be a cohesive unit without graphics of textAdditional warning statements and allergen declarationsFor prescription medicines, addition of a dispensing label spaceFor non-prescription medicines, addition of a Critical Health Information table

Although the TGA has implemented a 4-year transition period before the new TGOs become mandatory, it is recommended that where new labels are being created, the new TGOs are adhered to now. This will avoid a rush to update labelling at the end of the period.

For currently supplied products, the timing of labelling updates will need to be carefully managed over the transition period to ensure there is minimal write-off of packaging components and the appropriate variation applications are submitted (and approved) in a reasonable time period to ensure continued regulatory compliance.

This article was written by Lynda Notting from our Regulatory Services team