FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Issues New Information to Prepare for Label Changes

May 1, 2019

Australian regulators launched a series of posters to help health providers get consumers ready for upcoming changes to drug labels.

The Therapeutic Goods Administration said it is rolling out the labeling information as the four-year transition period for the new labeling rules winds down. The rules are scheduled to take effect in September 2020.

“To reduce medication errors, medicine labels need to be more consistent, with important information made more prominent and easier to read,” the agency says.

Under the new rules, prescription medicine cartons will have to display the drug’s name “on three non-opposing sides.” They also must have a space of at least 70 mm by 30 mm for a dispensing label—with very few exceptions—and more detailed allergy warnings, including newly added language about shellfish, fish, eggs, soya, milk and tree nuts.

When the new rules go into effect, pharmacists may still sell medicines with old labels that are already on the shelf or in dispensaries. It is especially important to make sure that patients who may be sensitive or allergic to certain substances are aware that allergens may not be declared on old labels, the agency said.

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