Adverse Drug Reaction & Quality Defect Reporting

Report a suspected side effect

The Health Products Regulatory Authority (HPRA) monitors the safety and quality of all authorised medicines on the Irish market and part of this activity is carried out through the review and evaluation of suspected adverse drug reactions (ADRs) and quality defects.

Healthcare professionals

All healthcare professionals are encouraged to use the national reporting system to report suspected adverse effect in one of the following ways:

• By using the HPRA’s online form .
• By downloading a copy of the HPRA adverse reaction report form ( Word version ) and e-mailing the completed form to medsafety@hpra.ie
• By printing the HPRA’s adverse reaction report form ( Word version ) and posting a completed copy to the HPRA by freepost.
• By calling the HPRA on (01) 676 4971.

To report a suspected quality defect, you can:

• Use the HPRA’s online reporting system
• Email: qualitydefects@hpra.ie
• Post:
  Compliance Department – Quality DefectsHealth Products Regulatory AuthorityKevin O'Malley House, Earlsfort CentreEarlsfort Terrace, Dublin 2
• Pharmacists may use the HPRA postage-paid 'green card' to report suspected quality defects, which is available upon request from the Market Compliance Section.
• Fax: +353-1-6764061 (Note: Fax machine is manned during office hours only)
• Telephone: (01) 6764971

Leaflets for people with sight challenges (XPIL)

Some pharmaceutical companies have chosen to display their Patient Information Leaflets (PIL) in PDF format and also as a text only version, called an XPIL. The XPIL is designed for people with sight challenges and can be read by screen readers, or printed in large print.