Our role in regulating the organ transplantation process
Organ transplantation has become a worldwide practice, bringing immense benefit to patients.
The extensive use of organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases.
Any centre that performs activity associated with the donation, testing, characterisation, procurement, preservation, transport or transplantation of organs fall within the scope of the legislation for ensuring the quality and safety of organs for transplantation. (Statutory Instrument No. 325 of 2012 (Quality and Safety of Human Organs Intended for Transplantation) Regulations), as amended.
As joint competent authorities, the HPRA shares responsibility for implementation of this legislation with Organ Donation and Transplant Ireland (ODTI) at the HSE.
Our role
As joint Competent Authority with the ODTI for the regulation of Organs for donation, we are responsible for:
- Implementation of this legislation,
- Receipt, evaluation and follow up for serious adverse reactions and events (SAR/Es) reports, in collaboration with the ODTI. You can find further information in the Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation and on the Report an Issue page.
- Inspection and authorisation of organ procurement organisations and transplantation centres.