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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 17 CELEX: 02024R1938-20240717 Registration of SoHO entities
1. SoHO competent authorities shall have procedures in place for the registration of SoHO entities in accordance with Article 35. 2. SoHO competent authorities shall verify that each SoHO entity registered in a national registry or the EU SoHO Platform has provided the information pursuant to Article 35(3) before publication of the registration on the EU SoHO Platform. Where national registries are in place, the SoHO competent authority shall submit the information on the registration to the EU SoHO Platform after carrying out that verification. 3. SoHO competent authorities shall verify whether an authorisation is required under Article 19, 25 or 26 for a registered SoHO entity, taking into account the declaration referred to in Article 35(4). 4. SoHO competent authorities shall identify whether the SoHO entity is a critical SoHO entity, in accordance with the criteria agreed by the SCB, taking into account the self-assessment carried out by the SoHO entity, where applicable, as referred to in Article 35(4). SoHO competent authorities shall update the registration information accordingly. |
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 17 CELEX: 02024R1938-20240717 5. Where, on the basis of the information provided, an entity does not fall within the definition of a SoHO entity as set out in Article 3, point (33), the SoHO competent authority shall remove the registration from the EU SoHO Platform and, where applicable, from the national registry, and inform the entity without undue delay. 6. SoHO competent authorities shall: (a) acknowledge receipt of the registration without undue delay; (b) request the SoHO entity to provide supplementary details on the information provided in accordance with Article 35(3), if needed; (c) provide instructions on the procedures to be followed to apply for an authorisation, where relevant; (d) where applicable, inform the SoHO entity of its status as a critical SoHO entity and of the related obligations pursuant to Articles 64 and 67; (e) inform the SoHO entity that its registration has been verified and published on the EU SoHO Platform. |
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 17 CELEX: 02024R1938-20240717 7. In the case of changes in the information registered by the SoHO entity in accordance with Article 35(6), SoHO competent authorities shall verify those changes and publish the updated registration on the EU SoHO Platform without undue delay, including in the case of cessation of SoHO activities of the SoHO entity concerned. |