National and European SoHO guidance 

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 may fall under the SoHO Regulation and you do not hold an existing tissue establishment or blood establishment authorisation, contact us via our online form.

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. 

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.