In 2024 we initiated targeted reviews on selected listed medicines that required safety warnings because the medicine contained the herbal ingredients Artemisia annua, Artemisia absinthium, Artemisia dracunculus, Artemisia frigida, Artemisia pallens, and Artemisia vulgaris.
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.
Listed medicines are only permitted to use low risk ingredients from a pre-approved list. Although these ingredients are considered low risk to the general adult population, some ingredients are contraindicated for specific groups of people.
For such ingredients, the TGA requires medicine sponsors to use warning statements on their medicine’s label to ensure the safety of listed medicines. Medicines that contain Artemisia annua, Artemisia absinthium, Artemisia dracunculus, Artemisia frigida, Artemisia pallens, and Artemisia vulgaris as active ingredients require the following warning statement:
- 'Do not use if pregnant or likely to become pregnant’.
The absence of this warning statement in medicines that contain certain Artemisia species may result in pregnant women taking a medicine that could pose a risk to their health.
What we asked sponsors
Sixteen listed medicines that contained Artemisia annua, Artemisia absinthium, Artemisia dracunculus, Artemisia frigida, Artemisia pallens, and Artemisia vulgaris as active 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 we found
The sponsors of all 16 medicines (100%) responded to our request for information, of which 12 medicines (75%) were found to include the required warning statements. The compliance status of two medicines could not be determined as they were not being manufactured or supplied. We found that:
Of the 2 medicines that were found to be missing the required warning statements:
- One medicine was missing the mandatory warning statement on their website. The sponsor updated this, and the medicine remains on the ARTG
- One medicine was missing the mandatory warning statement on their label. This medicine was recalled, and an infringement notice issued. This medicine has been cancelled from the ARTG
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 being over the quantity limits or 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.