Regulatory Information

Organs Regulation


Application for Organs

Organ procurement organisations and transplantation centres must apply to the HPRA for an organ procurement organisations and transplantation centres authorisation. In doing so, the applicant is required to complete the Application for Authorisation of an Organ Procurement Organisation/ Transplantation Centre and submit to the HPRA for approval. The process of approval involves the review of supporting documentation and inspections.

Should a procurement organisation or transplantation centre need to change any detail contained in their application for authorisation post submission, they must provide details of the change(s) in writing to the HPRA at compliance@hpra.ie or by post to Blood Tissues and Organs, Health Products Regulatory Authority, Compliance Department, Kevin O’ Malley House, Earlsfort Terrace, Dublin 2.

Variation to Organ Authorisation

Regulation 8 (1) of S.I. 325 of 2012 states that “A procurement organisation or transplantation centre shall not make a substantial change in a prescribed activity which it carries out without the prior written approval of the HPRA.”

Should an organ authorisation holder need to change any detail contained in their authorisation, they must submit an Application for a variation to an organ authorisation

All applications must be submitted prior to the change being implemented by the authorisation holder. 

Variations to the organ authorisation can be classified as administrative or technical.

A Framework for Quality and Safety of Human Organs Intended for Transplantation

In December 2014, the Health Services Executive (HSE), via the office for Organ Donation and Transplantation Ireland (ODTI), in conjunction with the HPRA, published a Framework for the Quality and Safety of Human Organs Intended for Transplantation as required by Part 3, Regulation 12 of S.I. 325 of 2012.

The framework provides for, and includes details on, the roles and responsibilities regarding the adoption and implementation of operating procedures to cover all stages of the chain from organ donation to transplantation. It outlines the principles for quality management systems and lays down specific requirements for the quality and safety of organs for transplantation.

Procurement organisations and transplantation centres involved at any stage of the chain from organ donation to transplantation should comply with the requirements of the framework for quality and safety.

Framework for Quality and Safety of Human Organs Intended for Transplantation – Version 1