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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 8 CELEX: 02024R1938-20240717 General responsibilities and obligations of SoHO competent authorities
1. SoHO competent authorities shall be responsible, within their territory, for SoHO supervisory activities in order to verify the effective compliance by: (a) SoHO entities with the requirements set out in this Regulation; and (b) SoHO preparations with their corresponding authorisation. 2. The SoHO national authority designated in accordance with Article 5(4) shall be responsible for coordinating the information exchanges with the Commission and with other Member States’ SoHO national authorities, as well as for carrying out other tasks, provided for in Article 4(2), Article 12(4), Article 13(2), (3) and (4), Article 16(1), Article 31(4), Article 33(13) and (14), Article 34(2), Article 62, Article 64(3), Article 65(3) and (4), and Article 68(2) and (5). The SoHO national authority may also be responsible for the task provided for in Article 12(1). |
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 8 CELEX: 02024R1938-20240717 3. SoHO competent authorities shall: (a) have, or have access to, a sufficient number of suitably qualified and experienced personnel, human and financial resources, operational capacity, and expertise, including technical expertise, to carry out the SoHO supervisory activities they have been made responsible for, efficiently and effectively; (b) have procedures in place to ensure compliance with the confidentiality obligations set out in Article 75; (c) ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities; (d) have appropriate and properly maintained premises and equipment to ensure that the personnel can perform their SoHO supervisory activities safely, efficiently and effectively; (e) have a quality management system or standardised documented procedures in place for the SoHO supervisory activities they have been made responsible for that includes a plan for continuity of their activities in the case of crisis situations that impede the normal performance of their tasks; (f) develop and implement, or provide access to, training programmes to ensure that personnel performing SoHO supervisory activities receive, for their area of competence, appropriate training; (g) provide opportunities for their personnel to participate in the Union training referred to in Article 70 where such training is available and relevant. |