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.

This page provides an overview of how the European Commission is working to implement Regulation and the role of the HPRA. 

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 SoHO Coordination Board (SCB) and multiple EU working groups to help develop harmonised processes for the new Regulation. The HPRA will review all documents produced by the SCB and will implement the relevant processes to ensure a smooth transition to the new Regulation.