Listed medicines containing mollusc-derived ingredients requiring warning statements

In 2024, we initiated targeted compliance reviews of selected listed medicines that required warning statements on their labels as they contained mollusc-derived ingredients.

What led to this review?

Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows us to determine the compliance of these medicines with relevant regulatory requirements.

Medicines that contain mollusc-derived ingredients are subject to the following warning statement requirement on medicine labels:

• 'Contains mollusc' or
• 'Contains mollusc products'.

The warning statement alerts consumers to the presence of mollusc-derived ingredients in the medicine. The absence of such a warning could lead to adverse reactions in individuals with allergies or sensitivities to mollusc-derived ingredients.

The warning statement was introduced on 1 March 2022 and is applicable to the labels of medicines listed in the ARTG on or after 1 March 2022, or released for supply on or after 1 March 2023. As the transition period to comply with the warning statement requirement has ended, a selection of listed medicines containing mollusc-derived ingredients was targeted to determine whether they comply with the requirement.

What did we do?

Twenty listed medicines that contained mollusc-derived ingredients were identified for review. We asked the sponsors of these medicines to provide the labels that were being used for these medicines to check the presence of the required warning statements.

What did we find?

The sponsors of all 20 medicines (100%) responded to the TGA's request for information, of which 12 medicines (60%) were found to comply with the legal requirement. The compliance status of one medicine (5%) could not be determined as it was never manufactured.

Of the 7 medicines (35%) that were found to be missing the required warning statement:

• Two medicines were recalled at the retail level;
• Sponsors of four medicines were required to quarantine the affected medicines under their control and amend the labels before further supply;
• One medicine was only supplied outside of Australia.

The compliance review results for each medicine are published on the page Listed medicine compliance reports.

Information for sponsors

If you are the sponsor of a listed medicine, you should:

• review the ingredients used in your medicine to ensure that any requirements and warning statements listed in the Therapeutic Goods (Permissible Ingredients) Determination are complied with;
• be aware that missing warning statements on medicine labels may result in recall of non-compliant stock;
• be aware that the requirements for ingredients in the Therapeutic Goods (Permissible Ingredients) Determination can change from time to time. It is the sponsor's responsibility to make sure that these changes are implemented to their medicine, and within the transition period if applicable; and
• be aware that repeatedly failing to comply with legislative requirements, such as not including the required warning statements on the label, could result in higher-level enforcement actions, including infringement notices or other penalties.