August 1, 2017
It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements. Been effective from 31st Aug 2016, there have been continuous developments to the proposed labeling rules emphasizing the need to be aligned with international labeling best practices and reduce medication errors. In a recent announcement, the TGA released some more facts about the proposed changes helpful for the Sponsors, healthcare professionals and consumers as well. Along with informative posters intend to raise awareness on medicine labeling requirements, there are key insights about the new rules and improvements such as: Prominently Displayed Active Ingredients
- AIs should be on the front of the pack
- Placed on front panel next/below to the medicine name
- Compared to old labels Ingredients should be in a larger minimum text size
- AIs are made easier to compare between medicines
Medicine Information
- Making it easy to recognize, CHI information on OTC medicines will always be in a consistent order
- To improve legibility, mandatory information should be in text colour which should stand out against background
- Allergens and declarable substances are mandatory on label
Pharmacy Dispensing
- For easy identification of medicinal products in dispensaries, cartons of prescription medicines must contain medicine name on three non-opposing sides
- 70 x 30 mm dedicated space for attaching a dispensing label for prescription medicines
Allergen Information
- Possibility of a longer list of substances to be be declared on a label if they have presence in the medicine
- Substances like crustacea, fish, eggs, soya, milk and tree nuts will need to be declared
Apart from aforementioned, the TGA labeling requirements, there might be other improvements which you may wish to know to launch your product successfully in Australia. With transition deadline till 2020, the sponsors may still have time to get comply with new TGA labeling requirements and make changes to their labels. But it is always suggestible to be prepared ahead of the time. Consult a local Regulatory expert.
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