Report a serious adverse reaction/event – tissues and cells

Fields marked with an asterisk (*) are mandatory.
• Please do not include any information that would identify the patient, healthcare professional, or other individuals involved. Donor, recipient and staff names (other than the reporter), are not required, and this information should be anonymised.
• Additional information may be provided in attachments, please ensure that the report identification number is included on any attachments. 
• A Guide to Reporting Serious Adverse Reactions (SAR) and Serious Adverse Events (SAE) Associated with Human Tissues and Cells is available in the safety section of the HPRA website.

The HPRA operates the national system for recording and reporting details of suspected adverse reactions occurring in Ireland. Please see full details of how personal data is processed in this area.

  1. Reporter information
  2. SAE or SAR details
  3. Implicated tissue or cells
  4. Details and categorisation
  5. Preview and submit

Reporter information