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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 60 CELEX: 02024R1938-20240717 SoHO release
A SoHO establishment that releases SoHO for distribution or export shall have a procedure in place, under the control of the releasing officer as referred to in Article 49, for SoHO release to ensure that the standards, or elements thereof, referred to in Articles 58 and 59 and their implementation, have been verified and documented prior to release and that all conditions included in any applicable authorisations granted in accordance with this Regulation have been complied with.
SoHO processed for autologous use or within-relationship use, without SoHO storage, shall not require release before human application. In such cases, the SoHO preparation authorisation shall include a specification of the quality control parameters to be monitored during the processing. |