Report an issue

You can report issues to us about the products we regulate. On this page, you can find information about reporting:

• side effects, safety issues and quality concerns about a medicine, medical device and other healthcare products

• shortages of medicines

• suspicious activity related to the sale, advertising or manufacture of healthcare products

• protected disclosures

Reporting side effects, safety issues and quality concerns

If you think you have had a side effect, also known as an adverse reaction, you can report it to us. You can also report other safety issues or quality concerns about medicines, medical devices and other products regulated by the HPRA.

Anyone can report, including patients, carers, other members of the public and healthcare professionals.

Medical advice

We cannot provide medical advice. If you are concerned about your health, you should contact your doctor, pharmacist or another healthcare professional involved in your care.

They can help with any questions you have about using, or continuing to use, a medicine or another healthcare product.

Submit an online report

You can report issues using our online reporting system.

• COVID-19 Vaccine Adverse Reaction

• Human Medicine Adverse Reaction

• Veterinary Medicines Adverse Reaction/Event

• Suspected Unexpected Serious Adverse Reaction (Clinical Trial Investigator)

• Medicine Quality Issue/Defect (Patients and Healthcare Professionals) 

• Medical Device Adverse Incident 

• Tissues and Cells Adverse Reaction/Event

Please see the relevant privacy notice under each form for full details on how your personal data is processed.

Download or print a reporting form

You can download a form and return it by email or post using the address listed in each form. 

• COVID-19 Vaccine Adverse Reaction (Privacy Notice – Pharmacovigilance and Eudravigilance Database is available here)

• 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)
  

• Suspected Unexpected Serious Adverse Reaction (Clinical Trial Investigator) (Privacy Notice Suspected Unexpected Serious Adverse Reaction Report (SUSAR) for Investigator Led Trials is available here)

• Medicines Quality Issue/Defect - Marketing Authorisation Holders, Manufacturers and Wholesalers (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) 

• Serious Adverse Reaction / Event Report Form for Human Organs Intended for Transplantation (Privacy Notice for organs intended for transplantation is available here) 

• ​Cosmetics - Undesirable Effect/Serious Undesirable Effect (Privacy Notice for Cosmetics Reporting form available here) 
  
  

Report medicines shortages

The HPRA is responsible for coordinating the management of shortages of human medicines on the Irish market. You can report information about medicines shortages to us. 

Report suspicious activities

You can contact us at +353 1 634 3871 or +353 1 634 3431 or email reportacase@hpra.ie with any information you may have about suspicious behaviour in the supply, advertising or manufacture of health products. 

Any information provided will be dealt with in the strictest confidence.

Phone numbers and email are monitored during office hours of 8am to 4pm - Monday to Friday only.

Protected disclosures

You can submit protected disclosures in relation to the regulatory functions performed by the HPRA.