Australia’s medicine labels to change for first time 15 years


New labels will include easier-to-find active ingredients, a critical information panel and designated space for a dispensing label

The TGA has announced it will be implementing two new labelling orders over four years, beginning on 31 August 2016.

A spokesperson told the AJP that the current Therapeutic Goods Order that sets out the requirements for packaging and labelling is now more than 15 years old “and does not reflect current best practice nor align with standards set internationally by overseas regulators”.

Over the last five years, the TGA has undertaken consultations and reviews that have identified safety concerns with the current labelling of medicines, leading to the drafting of drafted two new orders to address these concerns, they said.

The organisation has also adopted a four-year transition period in order to minimise the cost and impact of the changes on industry, and to align with the International Harmonisation of Ingredient Names (IHIN) labelling reform work which commenced in April 2016.

“These new changes aim to improve readability and usability of medicine labels by emphasising the active ingredient and critical health information of a particular medicine,” said the spokesperson.

A split of labelling requirements from one into two different orders was also applied to better reflect the different risk levels for prescription and non-prescription medicines.

These new standards will be available on the Federal Register of Legislation from 17 August 2016, and guidance on how to apply them will be published on the TGA website at the same time.

The main changes to medicine labels include:

  1. Active ingredients will be more prominent and easier to find.

  2. Most OTC medicines will have a Critical Health Information panel to help you find important information about your medicine.

  3. For non-prescription medicines, more substances that could cause an allergic reaction will need to be listed on labels, e.g. 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 CMI leaflet).

  4. 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 space will help ensure that other information included on a carton or bottle is not covered.

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