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).

The HPRA shares responsibility for implementation of this legislation with Organ Donation and Transplant Ireland (ODTI) at the HSE. 

Our role

We are the joint Competent Authority with the Health Services Executive (HSE) for the regulation of Organs for donation.

We are responsible for:

• Implementation of this legislation,
• Receipt, evaluation and follow up/onward reporting to ODTI (at present) of serious adverse reactions and events, and
• Inspection and authorisation of organ procurement organisations and transplantation centres.