Shane Moynihan (Dublin Mid West, Fianna Fail)
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1510. To ask the Minister for Health the measures being taken to improve the availability and supply of Creon (pancreatic enzymes) to Ireland. [10766/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Thank you, Deputy, for your query on the important issue of Creon shortages.

Companies are required to notify our medicines regulator, the Health Products Regulatory Authority (HPRA) of medicine shortages or potential shortages impacting the Irish market.

Viatris, the company that places Creon on the market in Ireland has notified the HPRA of a global supply constraint of Creon (pancreatin) medicines. Viatris has informed the HPRA that this constrained supply is due to high global demand for this medicine coupled with manufacturing capacity constraints and a shortage of the active pharmaceutical ingredient required to manufacture this medicine.

The HPRA is engaging closely with the company involved in the supply of Creon to keep the health system and the public informed and intermittent constrained supply is expected throughout 2025. The HPRA has also engaged actively with the European Medicines Agency (EMA) Medicine Shortages Single Point of Contact (SPOC) Working Party with regards the supply of Creon medicine as this is a situation involving multiple Member States.

Viatris has notified a current shortage of Creon for Children 5000 Gastro-resistant Granules, this shortage started on the 3rd of March 2025. The company anticipates resupply of Creon for Children 5000 Gastro-resistant Granules in Ireland on the 28th of March 2025.

The HPRA has held multiple recent meetings and engagements with Viatris and arising from these meetings approved two Batch Specific Requests (BSRs) of Creon medicines. These BSRs will help to improve the supply situation by allowing importation of Creon for Children 5000 Gastro-resistant Granules and Creon 25000 Gastro-Resistant Capsules from another European market where the company had identified available stock.

As of the 13th of March 2025, Creon 10000 Gastro-Resistant Capsules and Creon 25000 Gastro-Resistant Capsules are available for supply in the Irish market.

The HPRA hosts a list of current and resolved shortages on its website, where relevant details, including information on the supply of Creon, are maintained. Viatris has published information for healthcare professionals related to the supply constraints of Creon, which is available on the HPRA Medicine Shortages webpage. The webpage is updated daily as the HPRA receives new information.