Maria Bailey (Dún Laoghaire, Fine Gael)
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823. To ask the Minister for Health the position regarding persons with gardasil (details supplied); and if he will make a statement on the matter. [46886/17]

Simon Harris (Wicklow, Fine Gael)
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All medicines, including vaccines are subject to ongoing review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. Taking into account the totality of the available information, the benefits of the HPV vaccines continue to outweigh their risks. The safety of these vaccines continues to be monitored at EU level through the European Medicines Agency (EMA) and its expert committees, which includes representatives from member state competent authorities such as the Health Products Regulatory Authority (HPRA).

The HPRA is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland and operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions through this system. All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.