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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 7 CELEX: 02024R1938-20240717 Transparency
1. SoHO competent authorities shall: (a) carry out the SoHO supervisory activities they have been made responsible for in a transparent manner, at least by complying with the publication requirements provided for in this Regulation; and (b) make any enforcement decision pursuant to Article 19(7), (8) and (9), Article 25(3), (4) and (5), or Article 27(8), point (h), and the reasons for it, accessible and clear to the public in cases where: (i) a SoHO entity does not comply with this Regulation; or (ii) there is a serious risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction or to public health. 2. Paragraph 1 of this Article shall be without prejudice to Article 75 and to national legislation on access to information. 3. SoHO competent authorities shall lay down in their internal rules practical arrangements for implementing the transparency rules referred to in paragraph 1. |