The TGA will be initiating targeted compliance reviews of selected listed medicines that require safety warnings because the medicine contains the herbal ingredients Artemisia annua, Artemisia absinthium, Artemisia dracunculus, Artemisia frigida, Artemisia pallens, and Artemisia vulgaris.
If you are a consumer, please note that this is part of our normal review process and there is no immediate concern associated with the use of these types of listed medicines.
However, medicines containing certain Artemisia species should not be taken by women who are pregnant, think they may be pregnant, or intend to become pregnant. If you are in this group and are taking medicines containing Artemisia herbal ingredients, you are strongly encouraged to stop taking the medicine and seek advice from your doctor.
Background
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.
As such, we will be selecting listed medicines that contain Artemisia ingredients for compliance review to ensure that they display this warning statement.
I am a sponsor, what should I do?
If you are a sponsor of a listed medicine which includes an Artemisia ingredient, you are encouraged to re-evaluate the presentation of the goods including the medicine label, particularly for the warning statements required for your medicine.
It is important that you refer to relevant legislation, including the Therapeutic Goods (Permissible Ingredients) Determination which contains the list of ingredients allowed by the TGA for use in listed medicines and any specific requirements (such as warning statements) for each ingredient.
If your medicine is selected for review, you will receive a Request for Information notice. This notice will contain an explanation of the review process, outline the information you are required to submit and relevant due dates for your response.
What the TGA will do?
The TGA will commence desktop compliance reviews for a selection of listed medicines that contain Artemisia ingredients in the last quarter of 2023. These may either be selected randomly or based on regulatory intelligence.
We will send sponsors of these medicines a Request for Information notice informing them of the commencement of the review and outlining the information sponsors are required to submit. Upon receipt of the information provided by sponsors, we will assess the medicine against listing requirements, with particular focus on the required warning statements.
If no compliance deficiencies are identified for a selected medicine, the review will be concluded and there will be no further regulatory action. If deficiencies are identified, the medicine may be recalled and/or the sponsor will be given an opportunity to address the deficiencies. Additionally, enforcement actions (such as the cancellation of the medicine from the ARTG, issuing of infringement notices, etc.) may be taken.
Should sponsors cancel their listing rather than respond to the Request for Information notice, we may still request certain documentation be provided to ensure that the medicine met its regulatory requirements.
A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.