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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 24 CELEX: 02024R1938-20240717 4. SoHO competent authorities may decide that certain SoHO entities that do not fall within the definition of a SoHO establishment as set out in Article 3, point (35), also need to be authorised as SoHO establishments, in particular SoHO entities that: (a) have significant influence on the quality and safety of SoHO due to the scale, criticality or complexity of the SoHO activities they perform; or (b) carry out SoHO activities in connection with multiple SoHO establishments.
SoHO competent authorities shall inform the SoHO entity of such a decision and of the resulting obligation to comply with all provisions of this Regulation relating to SoHO establishments, including the submission of an application for SoHO establishment authorisation. |
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 24 CELEX: 02024R1938-20240717 5. SoHO establishment authorisations shall be valid throughout the Union for the period set out in the terms of the authorisation, when such a time period has been defined, or until a SoHO competent authority has suspended or withdrawn the authorisation, or until the SoHO establishment has ceased to conduct SoHO activities. Where a Member State has adopted a more stringent measure in accordance with Article 4, which relates to a specific SoHO establishment authorisation, that Member State may decline to recognise the validity of the SoHO establishment authorisation of another Member State until it has verified compliance with that more stringent measure. |
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 24 CELEX: 02024R1938-20240717 SoHO establishment authorisation system
1. SoHO competent authorities shall establish and maintain a system for receiving and processing applications for SoHO establishment authorisation in their territory. The system shall allow for the suspension and withdrawal of authorisations. 2. In accordance with Article 25, SoHO competent authorities shall authorise as SoHO establishments the SoHO entities that fall within the definition of a SoHO establishment as set out in Article 3, point (35). 3. SoHO competent authorities shall include all SoHO activities to be carried out by a SoHO establishment in the authorisation granted, including those SoHO activities to be carried out outside of the premises of the SoHO establishment. |