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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  71

CELEX:  02024R1938-20240717

5. Following each control, the Commission shall:
(a) prepare a draft report on the findings and, where appropriate, include recommendations addressing the shortcomings identified;
(b) send a copy of the draft report referred to in point (a) to the SoHO national authority concerned for its comments;
(c) take the comments referred to in point (b) into account in preparing the final report; and (d) make publicly available a summary of the final report on the EU SoHO Platform.
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  71

CELEX:  02024R1938-20240717

Commission controls
1. The Commission shall perform controls to confirm whether Member States effectively apply the requirements relating to:
(a) SoHO competent authorities and delegated bodies provided for in Chapter II;
(b) the SoHO supervisory activities carried out by SoHO competent authorities and delegated bodies;
(c) the notification and reporting requirements of this Regulation.
2. The Commission shall organise the controls referred to in paragraph 1 in cooperation with the SoHO national authorities, and shall carry them out in a manner that avoids unnecessary administrative burden.
3. When performing the controls referred to in paragraph 1 of this Article, the Commission shall consult the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d), on SoHO supervisory activities.
4. The Commission, in carrying out the controls referred to in paragraph 1 of this Article, may be supported by experts from the SoHO competent authorities selected, whenever possible, from the list referred to in Article 70(5). Experts from the SoHO competent authorities shall be given the same rights of access as the Commission.