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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 12 CELEX: 02024R1938-20240717 Communication and coordination between SoHO competent authorities
1. Where more than one SoHO competent authority is responsible for performing SoHO supervisory activities in a Member State pursuant to Article 5(2), the Member State or the SoHO national authority shall ensure efficient and effective coordination between all the SoHO competent authorities concerned in order to guarantee consistency and effectiveness of the SoHO supervisory activities performed on its territory. 2. Within a Member State, SoHO competent authorities shall cooperate with each other. They shall communicate information to each other and, in particular, to the SoHO national authority as necessary for the effective implementation of the SoHO supervisory activities provided for in this Regulation and of the tasks of the SoHO national authority, as referred to in Article 8(2). |
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 12 CELEX: 02024R1938-20240717 3. In cases where a SoHO competent authority issues an opinion to a SoHO entity on the applicability of this Regulation to a particular substance, product or activity on its territory, that SoHO competent authority shall notify the SoHO national authority of the opinion issued, which, in turn, shall notify the SCB, for publication of that opinion in the SoHO compendium. 4. Following a duly substantiated request from the SoHO national authority of another Member State, the SoHO national authority shall without undue delay, and ensuring compliance with the confidentiality obligations set out in Article 75, inform the requesting SoHO national authority of the outcome of the SoHO supervisory activities concerning a SoHO entity on its territory, and, as necessary and proportionate, provide the requesting SoHO national authority with the relevant documentation related to the SoHO supervisory activities referred to in Articles 27 and 28. |