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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 62 CELEX: 02024R1938-20240717 Critical SoHO supply sufficiency
1. Member States shall, within their territories and in collaboration with SoHO national authorities, SoHO competent authorities and SoHO entities, each within their respective competence, consider all reasonable efforts for achieving a sufficient, adequate and resilient supply of critical SoHO with a view to appropriately meet recipients’ needs, and to contribute to European self-sufficiency. 2. Member States shall make all reasonable efforts to: (a) facilitate public participation in SoHO donation activities for critical SoHO, with a view to ensuring a broad SoHO donor-base and SoHO donor-base resilience built on the standards concerning voluntary and unpaid donation in accordance with Article 54; (b) ensure that SoHO donor recruitment and retention strategies are put in place for critical SoHO, including communication campaigns and education programmes; (c) carry out the activities as referred to in paragraph 1 of this Article through preparedness and response measures, with due regard to Article 54; and (d) ensure optimal use of critical SoHO, taking into account therapeutic alternatives. |
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 62 CELEX: 02024R1938-20240717 Accordingly, Member States shall encourage the collection of SoHO with a strong public and non-profit sector involvement. 3. Critical SoHO entities shall establish appropriate mechanisms for the continuous monitoring of their stocks of critical SoHO and shall be able, in the event of shortages or upon request, to communicate such information to their SoHO competent authorities.
SoHO competent authorities shall, in turn, establish appropriate mechanisms to receive such information referred to in the first subparagraph and shall be able to get an overview of the availability of critical SoHO in their territories, when needed. 4. In cases where the availability of critical SoHO depends on commercial interests, each Member State shall seek that the critical SoHO entities, within the limit of their responsibilities, provide an appropriate and continuous supply of critical SoHO for recipients in their territory. |