Prepraring 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.

The HPRA will publish updates in the relevant areas of the site:

• Blood
• Tissues and cells 

Establishment of EU coordinating body and working groups 

The first update to the page is to communicate the establishment of the SoHo Coordination Board (SCB). The SCB has been set up to 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 have been created to support the rollout of the regulation.

Check the relevant pages for more information. It is also important to regularly check these pages over time in preparation for SoHo implementation. 

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It is important to check these pages regularly in preparation for SoHo implementation. You can also  subscribe to HPRA regulatory news alerts to receive notifications about important updates.