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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/EC (Text with EEA relevance) article 52 CELEX: 02024R1938-20240717 Objectives regarding SoHO donor protection
1. SoHO entities shall ensure respect for the dignity and integrity of SoHO donors. 2. SoHO entities shall ensure high levels of safety and protect the health of living SoHO donors from risks related to the SoHO donation, by identifying and minimising such risks before, during and after the SoHO collection. 3. SoHO competent authorities shall verify the compliance with this Chapter as well as with national legislation on consent and voluntary and unpaid donation. |