Written answers

Thursday, 19 January 2023

Department of Health

Medicinal Products

Photo of Catherine ConnollyCatherine Connolly (Galway West, Independent)
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307. To ask the Minister for Health if he is satisfied that the Health Products Regulatory Authority is providing data on adverse drug reactions in a timely manner to the European Medicines Agency, given there appears to be a difference between the number of adverse drug reactions on the HPRA website in regard to certain drugs (details supplied) and the number of adverse drug reactions recorded on the relevant EMA database; and if he will make a statement on the matter. [2488/23]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The HPRA confirmed that it complies with regulatory reporting requirements for submission of suspected adverse reactions for authorised medicines/vaccines to the European Medicines Agency’s (EMA’s) EudraVigilance (EV) database.

The HPRA operates a system of pharmacovigilance in accordance with National and European legislation and EU Good Pharmacovigilance Practice guidelines.

In relation to reports of suspected adverse reactions notified to the HPRA by health care professionals and members of the public, these are carefully evaluated by the HPRA’s pharmacovigilance department. Validated reports are submitted onward to the EudraVigilance database in a specified format and within defined regulatory reporting timelines (within 15 calendar days for serious reports and within 90 calendar days for non-serious reports). The EU regulatory network, which includes the HPRA and its counterparts in other EU Member States, as well as the EMA, continuously monitor EudraVigilance data to detect any new safety issues. Suspected adverse reaction reports submitted to the EudraVigilance database are updated by the EMA on www.adrreports.eu, where the information is publicly available in an anonymised format.

In relation to COVID-19 vaccines, the HPRA publishes information on the number of reports of suspected adverse reactions it has received on its website, www.hpra.ie. The number of reports published by the HPRA is and can be expected to be higher than the number available on www.adrreports.eu owing to the arrangements and processes in place for reporting. The data published by the HPRA include reports already available in EudraVigilance, as well as any that are recently received and which remain under processing for subsequent onward submission to EudraVigilance within the required regulatory reporting timeline (as noted above, within 15 or 90 calendar days depending on the nature of the report). In addition, reports submitted by the HPRA to EudraVigilance, as well as any Irish reports submitted by the licence holders (companies that hold the marketing authorisation), are published by the EMA at the next scheduled update on www.adrreports.eu, which is understood to be weekly for COVID-19 vaccines. A number of reports received by the HPRA will also not meet reporting requirements to EudraVigilance, for example, reports for which the brand of vaccine is unknown or which describe a medication error but without an associated suspected adverse reaction. Follow up for information to validate such reports is undertaken by the HPRA, as appropriate.

In addition to the submission of reports of suspected adverse reactions by the HPRA to EudraVigilance, the HPRA participates in the EMAs Safety Committee, the Pharmacovigilance Risk Assessment Committee, through which the HPRA maintains oversight of the evaluation of worldwide data concerning COVID-19 vaccines, including that from EudraVigilance, as well as from clinical trials and epidemiological studies. As for all medicines, should a safety issue arise, timely and appropriate regulatory action will be taken.


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