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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 10 CELEX: 02024R1938-20240717 Obligations of the delegated bodies
1. Delegated bodies to which SoHO supervisory activities are delegated in accordance with Article 9 shall: (a) meet the obligations set out in Article 8(3); (b) inform the delegating SoHO competent authorities, on a regular basis and whenever those delegating SoHO competent authorities so request, of the outcome of the SoHO supervisory activities performed by them; (c) immediately inform the delegating SoHO competent authorities whenever the outcome of the delegated SoHO supervisory activities indicates non-compliance or points to the likelihood of non-compliance, unless specific written arrangements established between those delegating SoHO competent authorities and the delegated bodies provide otherwise; and (d) fully cooperate with the delegating SoHO competent authorities, including by providing access to their premises and documentation, including their information technology (IT) systems. 2. Articles 6 and 75 and, where relevant, Articles 23 and 30 shall apply to delegated bodies. |