This work systematically analyzes the new Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO), adopted in 2024, which establishes a comprehensive framework governing the donation, collection, processing, storage, and clinical use of substances of human origin.
The Regulation, which governs the use of all Substances of Human Origin except solid organs, is an especially voluminous legislative text, consisting of 83 articles and approximately 180 pages. However, all issues are presented concisely and fully documented, in an organized and understandable manner, even for the non-legal professional, addressing matters of a highly complex regulatory framework such as the SoHO Regulation.
The work is not limited to analyzing the particularly interesting theoretical and bioethical issues related to SoHO applications but also highlights the most significant practical consequences expected from its implementation on the systems and professionals operating in the healthcare sector in the countries of the European Union and beyond.
