New EU Rules on Substances of Human Origin (SoHO)

The European Union has introduced new standards to enhance the safety and quality of substances of human origin (SoHO), such as blood, tissues, and cells. Published on July 17, 2024, in the Official Journal of the EU, the new Regulation aims to safeguard donor and recipient health while ensuring ethical practices and improved traceability across member states.

What Will the New EU Rules on SoHO Replace?

The new framework will replace the existing Directives with a more comprehensive set of rules, ensuring high standards for the collection, testing, and distribution of SoHO. The regulation will officially come into effect on August 7, 2027, allowing a three-year transition period, with an additional year granted for the implementation of certain provisions.

These new rules reflect the EU’s commitment to modernizing its healthcare systems, focusing on the availability of safe SoHO products while promoting innovation and maintaining public trust.

The Directorate-General for Health and Food Safety also released a promotional video explaining the new rules and their impact. This informative video highlights the importance of protecting both donors and recipients.

For more information and to view the video, visit the European Commission’s page on substances of human origin here.

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If you need to speak to someone about the new EU rules on SoHO and how this will impact recipient health and ensure ethical practices, contact us so we can assist you.

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