On the 13th of June 2024, the “Regulation (EU) 2024/1938 of the European Parliament and of the Council 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” of came into force it shall apply from 7 August 2027. The new act represents the final results of a long and, demanding work of negotiation between European Commission, Member States and the Council with the final aim to have only one high level act regulating all the Substances of Human Origin (SoHO) and, legally binding in its entirety for the Member States (MS). The principles and standards set in the Regulation combine the need to strength the mutual recognition of the oversight activities among MS and, the capacity of the SoHO system to deal with the innovation in the field facilitating the connection with competent authorities, professionals and final users of the SoHO preparations.
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