Australia’s medicine labels are becoming clearer

The Therapeutic Goods Administration (TGA) are changing medicine labels to make important information about your medicine easier to find. Labels will also include more information about any substances, such as allergens, that are contained in the medicine that could result in health problems in some people. These new requirements to make Australian medicine labels clearer and more consistent will be introduced from 31 August 2016. A four year-transition period applies. You will be able to review the new requirements before they come into effect. The new standards will be available on the Federal Register of Legislation on 17 August 2016 and a link to this site will be provided on this webpage. After changes come into effect on 31 August 2016, new medicine labels will start to gradually appear. These changes will be introduced over four years. This will allow sponsors enough time to transition to the new requirements. From 1 September 2020 all new medicine labels will need to meet the new requirements. Information is available to help sponsors understand the new labelling requirements and timing of changes. Labelling requirements for Australian medicines have not been updated for many years. These changes help bring Australian medicine labels up to date and align them with international best practice. They will help Australians to make more informed choices when it comes to their health. Main changes include: Active ingredients will be more prominent and easier to find. Most over the counter medicines will have a Critical Health Information panel to help you find important information about your medicine. For non-prescription medicines, more substances that could cause an allergic reaction will need to be listed on labels. These substances include crustacea, fish, eggs, soya, milk and tree nuts. Prescription medicines will also need to declare these substances on the label (or a statement directing you to the Consumer Medicine Information leaflet). Prescription medicines will also have a designated space for a dispensing label. These labels are applied by the pharmacist and include important information like your name and dosage instructions. The defined space for a dispensing label will help ensure that other information included on a carton or bottle is not covered. Some medicine labels will be more affected by these changes than others. Because of these changes, consumers may ask healthcare providers questions about whether their medicine has changed. For some medicines it may appear that the formulation has changed, as the label may show allergens that were previously not declared. Printable materials to help explain the changes are being developed and will be made available in late 2016.

TGA, 9 August 2016 ; ;