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
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.
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.
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.
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 email@example.com 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.
You can submit protected disclosures in relation to the regulatory functions performed by the HPRA.