Today the TGA published a public consultation on proposed labelling changes on large solid oral dosage forms, closing 11 July 2024.

This consultation includes significant proposals for new labelling requirements for Listed Medicines, that are:

- a large solid oral dosage form; AND

- intended to be swallowed whole; AND

- over a certain size threshold.

Under the changes, new labelling would be required after a 2 year transition period, including:

- a statement to warn consumers

- an image of the dosage unit that is true to size with the words 'actual size'

- the statement 'swallow with water' in the directions for use. 

The proposal was triggered by serious choking related adverse event reports, mostly related to Glucosamine/chondroitin, Fish/krill oils/omega 3, Calcium with vitamin D3 and Multivitamin/minerals.

Considering the number of products likely to be affected, we believe proposed changes have the potential to have significant impact, so we encourage you to respond to the consultation.

Click here to read the full details of the public consultation, plus CMA's suggested steps to take. CMA's current draft position developed during 2023 is also included.

In particular, if this affects you, we would encourage your response to include:

- the percentage of your products affected if the TGA proposed sizes were introduced

- what sizes are appropriate,

- commercial reasons why the 2 years transition period is insufficient,

- the regulatory impact on your business,

- responding to the consultation questions,

feedback on the TGA’s draft guidance in Appendix G of the consultation paper.

We would also encourage you to reach out to us on technical@cmaustralia.org.au to help inform CMA's industry response.

Your feedback will be instrumental in shaping the final outcome of these proposals, so we appreciate you taking the time to participate and help the industry more broadly.