Our Role


Blood and Blood Components

  • Our role is to ensure the quality and safety of blood and blood components used in hospitals, blood banks and other facilities in Ireland. 
  • We inspect and authorise all blood establishments in Ireland to ensure compliance with national and EU legislation.
  • We collaborate with the National Haemovigilance Office (NHO) to review and evaluate serious side effects and adverse events related to the collection and transfusion of blood and blood components. 
  • Hospital blood banks are required to be accredited by the Irish National Accreditation Board (INAB) to ISO15189. Should INAB withdraw or suspend an accreditation, we follow up to check that the blood bank continues to meet appropriate standards for the storage and supply of blood (and its components) for transfusion. 
  • The HPRA contributes to EU committees and working groups that are focused on the regulation of blood products and components
     

Tissues and Cells

  • Our role is to ensure that standards of quality and safety are adhered to for the donation, procurement, testing, processing and preservation of tissues and cells.
  • We inspect and authorise all tissues and cells facilities in Ireland to ensure compliance with national and EU legislation. 
  • We operate a national reporting system for the notification of serious adverse reactions and events (SAR/Es) related to the procurement, testing, processing, storage and distribution of tissues and cells.  SAR/Es can be reported to the HPRA through our website or by contacting us directly.
  • The HPRA contributes to EU committees and working groups that are focused on the regulation of tissues and cells.
  • We have no role in ethical or clinical codes applying to use of tissues and cells. 

 

Human Organs Intended for Transplantation

  • Our role is to ensure that standards of quality and safety are adhered to for the donation, testing, characterisation, procurement, preservation, transport and transplantation of human organs intended for transplant.
  • We inspect and authorise all human organ procurement and transplant centres in Ireland to ensure compliance with national and EU legislation.
  • The HPRA in conjunction with the Health Service Executive (HSE) operate a national reporting system for the notification of serious adverse reactions and events at any stage of the chain from donation to transplantation related to human organs. 
  • The HPRA contributes to EU committees and working groups that are focused on the regulation of organs intended for transplantation.
  • We have no role in ethical or clinical codes applying to use of organs for transplant.