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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7 Comments

  1. Peter Crothers
    11/08/2016

    Great news

  2. John Page
    11/08/2016

    Many current manufacturers package containers allow room for dispensing labels.
    Why then do many pharmacists continue to place their labels over the main printed info and avoid using the designated space for their label?
    Maybe the colleges need to revisit their Pharmacy practice lectures to reinforce some of the basic dispensing requirements.
    A retired old timer.

  3. pagophilus
    11/08/2016

    Will the designated space for a dispensing label be big enough to fit the dispensing label? If it isn’t there’s no point for it to be there. Primolut N anyone?

  4. william so
    11/08/2016

    Eye drops & eye ointments?

  5. GM
    11/08/2016

    My opinion is there should be no branded generic names. Patients find itvconfusing and opens up risk of overdose.Stick to the active ingredient drug and manufacturer only on label. That’s not too hard,surely.

  6. Cameron Walls
    12/08/2016

    It is disappointing that they require labelling for allergens, but not for gluten. Coeliacs have great difficultly knowing whether the medicine will make them worse or better.

    • Sam Treloar
      15/12/2016

      Therapeutic Goods Administration just informed me that sadly they’ve adopted the slack American standard of 20 ppm. Anything under that will not require the gluten content to be declared. My understanding is that it won’t say “contains gluten” but it won’t say “gluten-free” either. Sounds like industry push from Big Pharma has a hand in this. Not fair on us Coeliacs!

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