New European Union SoHO Regulation

The final approved text of the Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/ECText with EEA relevance has been published in the Official Journal of the EU and is available in all EU languages at this link.

This new regulation establishes measures setting high standards of quality and safety for all SoHO intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, recipients and offspring from medically assisted reproduction.