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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 69 CELEX: 02024R1938-20240717 1. The SCB shall assist SoHO competent authorities regarding the coordinated implementation of this Regulation and of the implementing and delegated acts adopted pursuant to it, by: (a) preparing opinions, at the request of SoHO competent authorities, submitted via their SoHO national authority, in accordance with Article 13(3), first subparagraph, on the regulatory status under this Regulation of a substance, product or activity and including such opinions in the SoHO compendium; (b) drawing up, by 7 August 2025, a list of the existing substances, products or activities for which an opinion on the regulatory status under this Regulation is not available but is needed to avoid risks to the safety of SoHO donors, recipients or offspring from medically assisted reproduction, or risks of a compromised access of recipients to safe and effective treatments, making it publicly available on the EU SoHO Platform, and subsequently updating that list at its discretion; (c) initiating at Union level, when preparing the opinions referred to in point (a) of this paragraph, a consultation with equivalent advisory bodies established under other relevant Union legislation in accordance with Article 13(3), second subparagraph, and including in the SoHO compendium the opinions concerning the Union legislation to be applied in cases where there is agreement with the equivalent advisory bodies; (d) documenting and publishing best practices on the implementation of SoHO supervisory activities on the EU SoHO Platform; (e) recording information notified in accordance with Article 13(4), and including such information in the SoHO compendium; (f) setting indicative criteria for ‘critical SoHO’ and for ‘critical SoHO entity’, providing and updating a list of what is considered a ‘critical SoHO’ by Member States, and making such information available to the SoHO national authorities on the EU SoHO Platform; (g) documenting practices followed by Member States to establish the conditions for compensation as referred to in Article 54(2); (h) providing assistance and advice for the cooperation between SoHO competent authorities and other competent authorities, with a view to ensuring coherent oversight where the regulatory status of SoHO changes, as provided for in Article 13(6); (i) providing advice on the minimum evidence necessary for the authorisation of a particular SoHO preparation, as referred to in Article 20(4), point (e); (j) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, as well as with the European Medicines Agency on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2001/83/EC, to support the harmonised implementation of standards and technical guidelines; (k) collaborating for the effective organisation of joint inspections and joint SoHO preparation assessment involving more than one Member State; (l) providing advice to the Commission on the functional specifications of the EU SoHO Platform; (m) in cooperation with the Commission, and, where appropriate, with the Advisory Committee on public health emergencies established pursuant to Article 24 of Regulation (EU) 2022/2371, supporting a coordinated approach to ensure the implementation of the national SoHO emergency plans in cases where an emergency affects more than one Member State or in the case of emergencies with an effect beyond the Union, in accordance with Article 63(7) of this Regulation; (n) providing assistance in other matters related to the coordination or the implementation of this Regulation. |
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 69 CELEX: 02024R1938-20240717 2. The Commission may adopt implementing acts setting out criteria and procedures for the consultation of advisory bodies established under other relevant Union legislation in relation to the performance of the SCB tasks.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2). |