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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 9 CELEX: 02024R1938-20240717 Delegation of certain SoHO supervisory activities to other bodies
1. Member States may empower a SoHO competent authority responsible for any of the SoHO supervisory activities referred to in Articles 20, 22, 27, 28 and 29, Article 31(1), Article 32(1), Article 33(2) and (3), Article 33(4), point (a), and Article 33(5), (6) and (8) to (12), to delegate that SoHO supervisory activity to one or more other bodies (‘delegated bodies’). 2. Member States shall ensure that the delegated bodies have the powers needed to effectively perform the SoHO supervisory activities delegated to them and fulfil the obligations set out in Article 10. SoHO competent authorities that delegate SoHO supervisory activities in accordance with paragraph 1 of this Article to a delegated body shall have in place a written agreement with that delegated body. |
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 9 CELEX: 02024R1938-20240717 3. The delegating SoHO competent authorities shall ensure that the written agreement referred to in paragraph 2 of this Article includes at least the following: (a) a precise description of the SoHO supervisory activities that the delegated body is expected to perform, and the conditions under which those activities are expected to be performed; (b) the condition that the delegated body participates in certification or other schemes at Union level, when available, to ensure the uniform application of principles of good practices required for their relevant sector; (c) a precise description of the arrangements ensuring an efficient and effective coordination between the delegating SoHO competent authority and the delegated body; (d) provisions on the fulfilment of the obligations set out in Articles 10 and 11; (e) provisions on its termination in the case of withdrawal of the delegation pursuant to Article 11. 4. SoHO competent authorities that have delegated SoHO supervisory activities pursuant to paragraph 1 shall submit the names and contact details of the delegated bodies, together with the details concerning the delegated SoHO supervisory activities, to the EU SoHO Platform. |