10 Small Submissions
No more than 10 Documents per submission
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
Medicine Information
Pharmacy Dispensing
Allergen Information
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.