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.

Please note that the HPRA cannot provide clinical (medical) advice. Therefore, if you have any medical queries or concerns about any symptoms you are experiencing, or if you have any queries about continuing treatment, or in relation to suitability for vaccination, you should consult a healthcare professional involved in your care.

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

Online Report Forms

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

COVID-19 Vaccine Adverse Reaction

Human Medicine Adverse Reaction

Veterinary Medicines Adverse Reaction

Serious Adverse Event (Clinical Trial Investigator)

Medicine Quality Issue/Defect (Patients and Healthcare Professionals) 

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.

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)
 
Serious Adverse Event (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

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. For these types of disclosures:

  • The person making the disclosure must be a current or past worker in a company which carries out activities regulated by the HPRA.

  • The worker must reasonably believe that the information disclosed and any allegations it contains regarding potential wrongdoing (as defined in the Act) are substantially true. 

Disclosure should be made by email to protecteddisclosures@hpra.ie or by letter to:

Chief Executive
Health Products Regulatory Authority
Kevin O’Malley House,
Earlsfort Terrace,
Dublin 2,
D02 XP77

The correspondence should state that the disclosure is being made under Section 7 of the Protected Disclosures Act 2014 and provide:

  • description of the relevant wrongdoing

  • copies of information that tends to show the wrongdoing in order to assist the investigation of the matters, and

  • preferred contact details.

The HPRA will use the information provided to decide whether or not to investigate. The nature of the disclosure may be such that a ‘for cause’ investigation is carried out, or the matter might be investigated at the next routine inspection, or in some cases, no investigation may be deemed warranted by the matters disclosed. The decision to investigate - or not - is the responsibility of the HPRA, on the basis of the information provided and in accordance with its regulatory remit and its own procedures. The discloser may be informed of the outcome, in general terms only.

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.