Report an Issue

Reporting Safety and Quality Concerns

If you are concerned that you have had a side effect to a medicine, or experienced a problem with any other type of healthcare product regulated by the HPRA, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the HPRA on your behalf.

If you wish to directly report issues relating to the use or quality of healthcare products you can use the HPRA’s online reporting service. Anyone can report issues relating to the safety and quality of healthcare products to the HPRA. This includes patients, carers, other members of the public and healthcare professionals.

Please note that in completing a report form, we understand that you are consenting to the information provided, including your contact details, to be stored securely by the HPRA. Your contact details will be used solely for the purposes of interaction with you regarding the report submitted. For the purposes of complying with our statutory and legal reporting requirements, summary details of this report (excluding personal information) may be shared with other bodies also involved in monitoring activities in accordance with HPRA obligations and data protection requirements. This ensures that the information is available to all relevant parties. The right exists to request a copy of personal data held by the HPRA and to have any inaccuracies in such data corrected or deleted.

Online Report Forms

The following forms can all be completed using the HPRA online reporting system:

Human Medicine Adverse Reaction

Veterinary Medicines Adverse Reaction

Serious Adverse Event (Clinical Trial Investigator) 

Medicine Quality Issue/Defect 

Medical Device Adverse Incident 

Tissues and Cells Adverse Reaction/Event 

 

Download / Print Forms

You can also download a form and return it by e-mail to the HPRA. Or you can download and print a form and post it to us.

Human Medicine Adverse Reaction (Privacy Notice – Pharmacovigilance and Eudravigilance Database is available here)

Veterinary Medicines Adverse Reaction (Privacy Notice - Veterinary Medicines Adverse Reaction form can be found here)
 
Serious Adverse Event (Clinical Trial Investigator) (Privacy Notice Suspected Unexpected Serious Adverse Reaction Report (SUSAR) for Investigator Led Trials is available here)

Medicine Quality Issue/Defect (Privacy Notice - Quality Defects Reporting is available here) 

Medical Device Adverse Incident (Privacy Notice - Medical Devices Incident Reporting is available here)

Tissues and Cells Adverse Reaction/Event (Privacy Notice - Human Tissues and Cells here) 
 
​Cosmetics - Undesirable Effect/Serious Undesirable Effect (Privacy Notice for Cosmetics Reporting form available here) 

Reports of shortages

The HPRA welcomes and encourages reports of medicinal products shortages from all stakeholders.

Please visit our dedicated area for medicine shortages for full details on how to report.

Report Suspicious Activities

You can contact us at +353-1-6343436 or email reportacase@hpra.ie with any information you may have regarding suspicious behaviour in the supply, advertising or manufacture of health products. 

Any information provided will be dealt with in strictest confidence.

Protected Disclosures

The purpose of the Protected Disclosures Act, 2014, is to provide a framework within which workers can raise concerns regarding potential wrongdoing that has come to their attention in connection with their work. The Act provides protection from penalisation if it results from the making of a protected disclosure.

The HPRA may receive protected disclosures from external persons in relation to the regulatory functions performed by the HPRA. These disclosures can be made for the attention of the Chief Executive by letter, by telephone, or by e-mail to info@hpra.ie. The HPRA will protect the identity of the discloser if possible but may be obliged to reveal the identity so that a proper investigation can be carried out. Anonymous disclosures will be investigated in so far as is practicable with the information supplied.