Regulatory information for human organs intended for transplantation
Applying for a new Organ Procurement Organisation/Transplantation Centre Authorisation
Organ procurement organisations and transplantation centres that carry out any prescribed activity must first apply for an organ procurement organisation and transplantation centre authorisation.
A 'prescribed activity' means any activity relating to the donation, testing, characterisation, procurement, preservation, transport or transplantation of organs intended for transplantation to the human body.
The applicant must complete an application for authorisation of an organ procurement organisation/transplantation centre and submit it to us for approval with the appropriate fee.
We encourage applicants to contact us to discuss any new application prior to applying. Please see the Contact Us page.
Variation to an 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, with the appropriate fee.
Variations to the authorisation are classified as either -
- administrative (fee code 330) - requiring a limited amount of assessment by an inspector, or
- technical (fee code 331) - requiring significant assessment by an inspector with a possible site inspection required.
Applicants are welcome to contact us prior to applying to discuss the proposed changes further. Please see the Contact Us page.
A Framework for Quality and Safety of Human Organs Intended for Transplantation
The Health Services Executive (HSE), via Organ Donation and Transplantation Ireland (ODTI), in conjunction with the HPRA, has published a Framework for the Quality and Safety of Human Organs Intended for Transplantation.
It outlines the roles and responsibilities regarding the adoption and implementation of operating procedures to cover all stages 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 should comply with the requirements of the framework for quality and safety.