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Written by Laurence Amand-Eeckhout (3rd edition, updated on 10.09.2024).
On 13 June 2024, as part of efforts to build a strong European health union, the EU adopted a regulation that updates and expands EU legislation on blood, tissues and cells. The new rules establish high standards of quality and safety for substances of human origin (SoHOs) intended for human application, improve the protection of donors, recipients, and offspring born from medically assisted reproduction, reinforce the principle of voluntary and unpaid donation in the EU, and strengthen the national collection systems to lower the risks of shortages.
The European Commission tabled its proposal in July 2022. On 14 December 2023, Parliament and Council reached a provisional agreement on the proposal, which was approved in plenary on 24 April 2024 and by the Council on 27 May 2024. The final text was signed on 13 June 2024, and published in the Official Journal of the EU on 17 July 2024. The regulation will come into force 3 years after its publication in the Official Journal.
Complete version
- September 2024: Standards of quality and safety for substances of human origin intended for human application (3rd edition)
| Proposal for a regulation of the European Parliament and of the Council 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 | ||
| Committee responsible: | Environment, Public Health and Food Safety (ENVI) | COM(2022)338 14.7.2022 |
| Rapporteur: | Nathalie Colin-Oesterlé (EPP, France) | 2022/0216 (COD) |
| Shadow rapporteurs: | Nicolás González Casares (S&D, Spain) Andreas Glueck (Renew, Germany) Tilly Metz (Greens/EFA, Luxembourg) Joanna Kopcińska (ECR, Poland) Kateřina Konečná (The Left, Czechia) | Ordinary legislative procedure (COD) (Parliament and Council on equal footing – formerly ‘co-decision’) |
| Procedure completed. | Regulation (EU) 2024/1938 OJ L, 2024/1938, 17.7.2024 | |
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