Listed medicines using indications related to diarrhoea requiring a warning statement

We will be initiating targeted compliance reviews of selected listed medicines that include indications related to diarrhoea and are subject to specific warning statements. The targeted indications are:

• Decrease/reduce loose stools
• Decrease/reduce/relieve diarrhoea
• Helps decrease/reduce/relieve symptoms of traveller's diarrhoea
• Helps reduce occurrence of diarrhoea
• Helps reduce occurrence of symptoms of traveller's diarrhoea
• Atisara hara/ease diarrhoea

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 the TGA to determine the compliance of these medicines with relevant regulatory requirements.

Listed medicines must only use indications drawn exclusively from a list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. Medicines that contain the abovementioned indications are currently required to display the following warning statement:

• 'Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).’

The absence of the required warning statement may result in consumers not seeking appropriate medical advice in a timely manner, leading to adverse health outcomes.

We will be selecting listed medicines that contain the above indications for compliance review to ensure that they display the required warning statement.

I am a sponsor, what should I do?

The Therapeutic Goods (Permissible Indications) Determination - external site contains the list of indications allowed by the TGA for use in listed medicines and any specific requirements (such as warning statements) for each indication.

If you are a sponsor of a listed medicine that contains one or more of the abovementioned indications, you are encouraged to re-evaluate the presentation of the goods to ensure that the required warning statement is present.

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.

If you decide to cancel the listing of your medicine in response to the Request for Information notice, we may still request certain documentation to be provided to ensure that the certifications made at the time of listing were correct.

What will the TGA do?

The TGA will commence desktop compliance reviews for a selection of listed medicines that contain one or more of the abovementioned indications and therefore require a warning statement. 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 statement.

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 recall, cancellation of the medicine from the ARTG, issuing of infringement notices, etc.) may be taken.

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