Written answers

Wednesday, 25 January 2023

Department of Health

Medicinal Products

Photo of Michael RingMichael Ring (Mayo, Fine Gael)
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155. To ask the Minister for Health when a drug (details supplied) will be available again, in view of the fact that this is having a very negative effect on persons who were prescribed the drug but now cannot obtain it; and if he will make a statement on the matter. [3395/23]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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After consulting with the Health Products Regulatory Authority (HPRA). I can confirm that the marketing authorisation holder for Ozempic Novo Nordisk, has notified the HPRA of intermittent supply issues with Ozempic products due to increased global demand. The company notified a shortage of the product's 0.25mg and 0.5mg strength effective from 10th January. The company expects resupply of these the week of 12th February. The company anticipates that intermittent supply will continue through 2023. Novo Nordisk has implemented monthly allocations to help ensure continuity of supply and equitable distribution of Ozempic stock to Irish patients. Novo Nordisk has also contacted healthcare professionals to update them on the current supply issue.

The HPRA has regularly engaged with the company and met with it on this issue. The challenging supply circumstances are global, and Ireland is not the only country impacted. The HPRA has discussed the issue with the European Medicines Agency and the EU shortage network. The intermittent supply of Ozempic has been notified to the HSE as clinical treatment of patients is outside of the HPRA's remit.

From a regulatory perspective, the HPRA remains open to any assistance it can provide, including expediting assessments should the company wish to supply products from other markets.

Further updates relating to the Ozempic supply challenges will be found on the HPRA's Medicine Shortages webpage, including a hyperlink to Novo Nordisk communication to stakeholders.

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