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Adverse Reaction & Quality Defect Reporting

Report a suspected side effect

The Health Products Regulatory Authority (HPRA) monitors the safety and quality of all authorised medicines available on the Irish market on an on-going basis and part of this monitoring is carried out through the review and evaluation of suspected adverse drug reactions (ADRs) and quality defects. The HPRA’s website includes a facility for reporting these online.

Healthcare professionals

All healthcare professionals are encouraged to use the national system to report suspected ADRs. Suspected ADRs may be reported using the on-line form. A downloadable version of the form is also available, which can be filled in manually and sent freepost to the HPRA.

The HPRA is always keen to help, encourage and establish good safety and monitoring reporting practices. Any centres or practices wishing to develop their reporting systems should contact the relevant sections of the HPRA for further information.

In this regard, for suspected ADR reporting, the HPRA Pharmacovigilance Section may be contacted at medsafety@hpra.ie, by telephone on +353 (0)1-676 4971, or by fax on +353 (0)1-676 2517.

With respect to quality defect reporting, the HPRA Market Compliance Section may be contacted at qualitydefects@hpra.ie, by telephone on +353 (0)1-676 4971 and by fax on +353 (0)1-676 4061.

Members of the public

If you are concerned that you have had a side effect to a medicine, contact your doctor or pharmacist who will advise on any treatment you may need. They may also report the suspected side effect to the HPRA. Should you wish, you can also report side effects directly to the HPRA.

While having a side effect while taking a medicine does not necessarily mean that it is has been caused by the medicine you took or received, the HPRA encourages people to report all suspected side effects so that if there is an issue it can be addressed.

You may report a suspected side effect or adverse reaction in a number of ways:

  1. through your doctor, pharmacist or nurse who can then notify the HPRA
  2. directly, via www.hpra.ie
  3. by calling the HPRA on +353 (0)1-676 4971

Registering with the HPRA for safety alerts and updates

Users of the HPRA website have the option of registering their contact information with the HPRA to enable them to receive direct and immediate notification of alerts/updates by email or text message. To facilitate prompt access to these updates, users are encouraged to avail of this option by registering on www.hpra.ie.

Useful Information on the ongoing safety of medicines

Information on suspected side effects, also known as suspected adverse drug reactions, of all medicines approved in the European Union (EU) can be obtained through a website maintained by the European Medicines Agency (EMA): http://www.adrreports.eu/EN/index.html. Suspected side effects are reported by patients, consumers and healthcare professionals. These reports are suspected but not necessarily established side effects. They may not be related to or caused by the medicine. National medicines regulatory authorities or pharmaceutical companies that hold the marketing authorisation for the medicine concerned are obliged to transmit these reports electronically to EudraVigilance, the European database of suspected side effects reported with medicines authorised in the European Economic Area (EEA). The information made available through the public website comes directly from EudraVigilance.

Additionally, the Pharmacovigilance Risk Assessment Committee (PRAC) is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines. The agendas, minutes and meeting highlights from the PRAC plenary meetings, which can contain important safety information about medicines, are available at the following link:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp&mid=WC0b01ac058058cb18