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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  31

CELEX:  02024R1938-20240717

Extraction, submission and publication of activity data
1. SoHO competent authorities shall verify that SoHO entities that have activity data collection and reporting obligations pursuant to Article 41 submit to their SoHO competent authorities, via the EU SoHO Platform, an annual report with those activity data. The EU SoHO Platform shall allow for the compilation of the annual reports submitted by the SoHO entities and provide the SoHO competent authorities with an annual aggregated report with the activity data from their SoHO entities.
2. By way of derogation from paragraph 1 of this Article, Member States may decide that SoHO entities shall submit the activity data referred to in Article 41(1) to SoHO competent authorities through national or international registries, in cases where such registries collect activity data matching the data sets indicated on the EU SoHO Platform. In such case, the SoHO competent authorities shall submit those activity data in accordance with the implementing acts adopted pursuant to Article 41(3).
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  31

CELEX:  02024R1938-20240717

3. SoHO competent authorities shall ensure that the annual aggregated report of activity data for their SoHO entities is made publicly available in their Member States, including via the internet. The annual aggregated report of activity data may also be published on the EU SoHO Platform after review and approval by SoHO national authorities.
4. The Commission shall compile the annual aggregated reports from the SoHO competent authorities and prepare an annual Union SoHO activity report. After having shared that report with the SoHO national authorities for their review and approval, the Commission shall publish the annual Union SoHO activity report and make it available on the EU SoHO Platform.