Denise Mitchell (Dublin Bay North, Sinn Fein)
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116. To ask the Minister for Health Health when the Health Products Regulatory Authority expects to have rivotril back in stock; and if he will make a statement on the matter. [46120/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Unfortunately, medicine shortages have become increasingly prevalent worldwide over the past decade and are a feature of modern health systems around the world. There are many reasons for such shortages including shortages of raw materials, manufacturing difficulties, logistical/transport issues or product recalls due to potential quality defects.

Medicines shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicines shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. Ireland has a multi-stakeholder medicines shortages framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

The HPRA has been notified of a shortage of Rivotril 0.5 mg Tablets. The company that places the product on the market (Roche) has stated that the shortage is due to a manufacturing delay, and resupply is expected at the end of September.

Further information on current and resolved shortages can be found on the shortages page of the HPRA’s website. The website is updated daily as we receive new information.

www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages