Written answers

Tuesday, 15 May 2018

Department of Health

Medicinal Products Regulation

Photo of Clare DalyClare Daly (Dublin Fingal, Independent)
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371. To ask the Minister for Health the role of the HPRA in reporting side effects in the context of a drug (details supplied); and if he will make a statement on the matter. [20928/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The information that the Deputy seeks is not readily available. Therefore, I have asked the Health Products Regulatory Authority (HPRA) to investigate the matter and reply directly to the Deputy.

It is important to reiterate that the HPRA and the European Medicines Agency continually monitor adverse events to vaccination. HPV is one of the most closely studied and monitored medicinal products. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. Mild and temporary reactions to any kind of vaccination are not unusual.

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