EU: New Regulation on Substances of Human Origin (SoHO)
The European Commission has published a new Regulation (2024/1938) providing new rules on standards of quality and safety for substances of human origin (SoHO).
The Regulation will replace the current rules for blood (Directive 2002/98/EC), tissues and cells (Directive 2004/23/EC), introducing new measures to improve oversight and safety across Europe. It will also include substances that were previously unregulated, for example, faecal microbiota and human breast milk.
Most of the new rules will come into force in August 2027, with other rules coming into force in 2028.
Sources:
HPRA: News and Events
EU Regulation 2024/1938
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