Guidance on Implementation of SoHO Regulation
We will keep this page updated with any available relevant documents to assist stakeholders in implementing the SoHO Regulation. All stakeholders are encouraged to read these documents and consider the implications for their activities.
The HPRA aims to highlight relevant documents and requirements to stakeholders through direct contact, where possible.
If your activities fall under the SoHO Regulation and you do not hold an existing tissue establishment or blood establishment authorisation, contact us via our online form. Under Category, choose “Blood, tissues and organs” and under Topic, choose “Compliance” to complete the contact form, including a brief description of your activities.
Documents produced by the SoHO Coordination Board
The documents produced and approved by the SCB are available on the European Commission website. Please visit this website and review relevant documents.
All stakeholders are encouraged to read these documents and consider the implications for their activities.
In particular, the following documents provide key guidance. We will expand this list as additional information becomes available. The HPRA will also publish guidance on how to register as an entity in Ireland in due course.
The SoHO Regulation all you need to know to get started
PDF : 315 KB | 01/07/2026This document guides stakeholders through the essentials of the SoHO Regulation. It will assist you in ensuring that your site is compliant with relevant provisions of the Regulation by the 7 August 2026.
Recommendations-and-Guidance-document-for-the-Management-of-SoHO-in-Hospitals
PDF : 2703 KB | 01/07/2026This is a practical tool to support hospital professionals involved in the use of SoHO in their daily activities. It provides legal and administrative guidance to enhance quality and safety in SoHO management and to ensure compliance with the Regulation.
Recommendations-and-Guidance-document-for-the-Management-of-SoHO-in-Non-Hospital-Entities
PDF : 1928 KB | 01/07/2026This is a practical tool to support professionals involved in the use of SoHO in their daily activities in non-hospital settings, or facilities that are not part of a large hospital e.g. private labs, clinics, SoHO Registries, private practices, etc.
Staying Updated
It is important for blood and tissue establishments to stay up to date and ensure readiness for compliance with requirements by 7 August 2027. We recommend:
- Regularly checking the HPRA website for updates and new guidance
- Subscribing to HPRA alerts to receive updates by email
- Contacting us if your activities may fall under SoHO but you are not yet authorised
- Contacting us with queries
To contact us, use our online form. Under Category, choose “Blood, tissues and organs” and under Topic, choose “Compliance”.