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Listed medicines requiring a pregnancy warning statement

30 March 2022

We will be initiating targeted compliance reviews of selected listed medicines that require warning statements related to use during pregnancy.

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.

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 contain low risk ingredients from a pre-approved list at certain quantities. Although these ingredients are considered low risk to the general adult population, some may still pose a risk during pregnancy.

One tool that we use to ensure the safety of listed medicines for specific population groups, such as pregnant women, is by using warning statements on the medicine label and any other advertising materials.

There are over 80 ingredients approved for use in listed medicines which may require a warning statement about pregnancy. Examples of warning statements can include:

  • 'Do not use if pregnant or likely to become pregnant'
  • 'Not recommended for use by pregnant and lactating women'
  • 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional'

The absence of these warning statements for medicines that contain these ingredients may result in accidental use during pregnancy resulting in the increased possibility of adverse events.

As such, we will be selecting listed medicines that contain any of these ingredients for compliance review to ensure they comply with the requirements related to pregnancy warning statements.

I am a sponsor, what should I do?

The Therapeutic Goods (Permissible Ingredients) Determination contains the list of ingredients allowed by the TGA for use in listed medicines and any specific requirements for each ingredient.

Additionally, the Poisons Standard also has specific requirements for some of these ingredients.

If you are a sponsor of a listed medicine which contains an ingredient that requires a warning statement relating to pregnancy, you are encouraged to:

  • re-evaluate the presentation of the goods, including the medicine label and web advertising, particularly for the warning statements required for your medicine.

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 will the TGA do?

We will commence desktop compliance reviews for a selection of listed medicines requiring a warning statement related to pregnancy in the first quarter of 2022. These may either be selected randomly or on the basis of 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 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 to be provided to ensure that certifications made at the time of listing were correct.

A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.