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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 46 CELEX: 02024R1938-20240717 5. The legal entity that holds the SoHO establishment authorisation shall be based in the Member State where the SoHO establishment is authorised. |
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 46 CELEX: 02024R1938-20240717 Application for SoHO establishment authorisation
1. SoHO entities shall submit the application for authorisation as SoHO establishment to the SoHO competent authorities of their territories. 2. The applicant SoHO establishment shall provide the name and contact details of the responsible person as referred to in Article 36.
The SoHO establishment shall not make any significant changes with regard to the SoHO or the SoHO activities subject to the authorisation without the prior written authorisation of the SoHO competent authority. 3. Significant changes for the purposes of paragraph 2 means changes relating to the types of SoHO concerned, to the types of SoHO activities carried out, to the use of new premises or to the modification of premises having an impact on the conditions under which SoHO activities are carried out. 4. SoHO establishments shall also, without undue delay, inform their SoHO competent authorities of any changes of an administrative nature, related to the SoHO establishment authorisation, including a permanent or temporary replacement of the responsible person. |