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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 66 CELEX: 02024R1938-20240717 Emergency derogations in man-made or natural disasters
1. Insofar as necessary to ensure supply of critical SoHO, Member States may allow for derogations from certain standards and obligations set out in this Regulation when large scale life-threatening situations in the context of man-made or natural disasters, in particular in the context of armed conflicts, pose a risk to human life, and such derogations are the only measure available to mitigate the risk. Derogations shall not be granted from the provisions of this Regulation that concern voluntary and unpaid donation and SoHO donor consent. The derogations shall be applied in a manner that ensures the protection of SoHO donors and SoHO recipients to the maximum extent possible in the circumstances of the crisis. 2. Member States granting such derogations shall inform the other Member States and the Commission without undue delay and provide reasons for the measures taken. |