Preparing for SoHO – updates on implementation

New EU rules for substances of human origin (SoHO) will replace existing regulations for blood, tissues, and cells. These changes will start from 7 August 2027, with some parts delayed until 2028.

Organisations working with these substances must prepare for compliance with the new regulations. To support compliance, it is important to stay informed about developments as implementation progresses. This page will be updated with key information and guidance.

When an update is critical, the HPRA will issue a regulatory news alert to its web subscribers. To receive these, subscribe to My Alerts.

See below for the latest updates relating to preparations to implement SoHO.

Establishment of EU coordination body and working groups 

The SoHO Coordination Board (SCB) was set up in January 2025 to act as an advisory body to support Member States to implement the SoHO Regulation. It provides guidance, advice, and oversight support to national authorities.

In addition to the SCB, six SoHO working groups started meeting in April and May 2025 to support the rollout of the regulation. These working groups will develop guidance and recommendations for people working in the sector that will be reviewed and approved by the SCB.

The working groups will focus on the following areas:

  • Entity registration
  • SoHO preparation authorisation
  • Inspection
  • Vigilance and traceability
  • Supply
  • Regulatory questions

The HPRA is a member of the SCB and will be represented at its meetings. The HPRA also has representatives on most of the working groups.