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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 11 CELEX: 02024R1938-20240717 Obligations of the delegating SoHO competent authorities
SoHO competent authorities that have delegated certain SoHO supervisory activities to delegated bodies in accordance with Article 9 shall: (a) regularly conduct audits of the delegated bodies; (b) fully or partly withdraw the delegation without delay, where necessary, and in particular in cases where: (i) there is evidence that the delegated bodies are failing to properly perform the SoHO supervisory activities delegated to them; (ii) the delegated bodies have failed to take appropriate and timely action to remedy the shortcomings identified in the course of conducting SoHO supervisory activities; or (iii) there is evidence that the independence or impartiality of the delegated bodies has been compromised.
The interval between the audits referred to in the first paragraph, point (a), of this Article shall be determined by the delegating SoHO competent authority, taking into account the participation of the delegated bodies in certification or other schemes referred to in Article 9(3), point (b), as well as the scope and the impact of the delegated SoHO supervisory activities on the quality and safety of SoHO. |