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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 55 CELEX: 02024R1938-20240717 Standards concerning information to be provided prior to consent
1. SoHO entities shall provide living SoHO donors or, where applicable, any persons granting consent on behalf of a SoHO donor, with all appropriate information relating to the SoHO donation process, in accordance with national legislation. 2. SoHO entities shall provide the information referred to in paragraph 1 before the consent to donate is granted. SoHO entities shall provide the information in an accurate and clear manner, using terms that are easily understood by the SoHO donors or, if applicable, any persons granting consent on their behalf. The information shall not be misleading, in particular as to the benefits of the donation for future recipients of the SoHO concerned. |
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 55 CELEX: 02024R1938-20240717 3. In the case of living SoHO donors or, where applicable, persons granting consent on their behalf, SoHO entities shall provide information regarding: (a) the purpose and nature of the SoHO donation; (b) the intended use of the donated SoHO, specifically covering proven benefits for the future SoHO recipients and any possible research or commercial uses of SoHO, including the use to manufacture products regulated by other Union legislation, as referred to in Article 2(6), to which specific consent shall be granted; (c) the consequences and risks of the SoHO donation; (d) the obligation for consent, in accordance with national legislation, in order for SoHO collection to be carried out; (e) the right to revoke consent and any restrictions on that right after the collection; (f) the purpose of the tests that will be performed in the course of the SoHO donor health evaluation, in accordance with Article 53(2); (g) the right of the SoHO donor or, where applicable, the person granting consent on their behalf to receive the confirmed results of the tests when relevant for their health, in accordance with national legislation; (h) the recording and protection of SoHO donor’s personal data, including health data, and medical confidentiality, including any potential sharing of data in the interest of the SoHO donor health monitoring and of public health, as necessary and proportionate, in accordance with Article 76; (i) the possibility that the SoHO donor identity may be revealed to the offspring from medically assisted reproduction that is born as a result of their SoHO donation in cases where national legislation grants that right to such offspring; (j) other applicable safeguards to protect the SoHO donor. |
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 55 CELEX: 02024R1938-20240717 4. In the case of deceased SoHO donors, SoHO entities shall provide any persons granting consent to collection on their behalf in accordance with national legislation, with the information referred to in paragraph 3, points (a), (b), (d) and (e). |