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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 28 CELEX: 02024R1938-20240717 Inspections of SoHO entities, other than SoHO establishments, and of third parties
1. SoHO competent authorities may carry out, pursuant to Article 27(1), inspections of SoHO entities other than SoHO establishments, and of the third parties contracted, as necessary and proportionate to the risks associated with the SoHO and the SoHO activities registered for that SoHO entity, and to the SoHO entity’s past compliance records. 2. In the cases referred to in paragraph 1 of this Article, Article 27 shall apply, mutatis mutandis, to the inspection of SoHO entities other than SoHO establishments and of the third parties contracted. |