Dáil Éireann Debate, Thursday - 6 February 2025
236. Deputy Colm Burke asked the Minister for Health if any further consultation has taken place between her Department and the Health Products Regulatory Authority on the matter of uromune becoming available for the treatment of recurrent urinary tract infections, given that it is becoming more readily available as a treatment across the world; and if she will make a statement on the matter. [3744/25]
View answerUromune is not authorised nationally in Ireland, nor is it centrally authorised by the European Medicines Agency (EMA). Our medicines regulator, the Health Products Regulatory Authority (HPRA) has also advised that, while there are some international clinical trials investigating the use of Uromune in the context of urinary tract infections, it has not received any application to conduct a clinical trial with this medicine in Ireland.
If the safe and efficacious use of Uromune in the treatment of recurrent urinary tract infections is demonstrated through successful clinical trials, the marketing authorisation holder may choose to apply to the EMA or the HPRA to place the medicine on the market. The decision to make such an application can only be made by the marketing authorisation holder. The Minister for Health has no role in the authorisation process for medicinal products.
