| Author (Corporate) | Council of the European Union, European Parliament |
|---|---|
| Series Title | Official Journal of the European Union |
| Series Details | (L) 2024/1938 |
| Publication Date | 17/07/2024 |
| Content Type | Blog & Commentary, Legislation, News, Policy-making |
Summary:Regulation (EU) 2024/1938 - adopted by the co-legislators on 13 June 2024 - concerning standards of quality and safety for substances of human origin intended for human application. It repeals Directive 2002/98/EC and Directive 2004/23/EC. This is a text with EEA relevance. Further information:This Regulation establishes measures that set high standards of quality and safety for all substances of human origin (SoHO) intended for human application and for activities related to those substances. It ensures a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction, including by strengthening the continuity of supply of critical SoHO. The Act repeals the previous framework addressing the safety of activities spanning from donation to human application - Directive 2002/98/EC (also known as Blood Directive) and Directive 2004/83/EC (also known as Tissues & Cells Directive). An evaluation carried out on that legislation showed that it no longer addressed the scientific and technical state of the art and required updating. The COVID-19 (coronavirus) pandemic further highlighted some of those shortcomings. A draft law was adopted by the European Commission on 14 July 2022 to revise the existing rules. It was seen as the concluding building block in the wider revision of the framework for blood, tissues and cells. The plenary of the European Parliament endorsed a negotiating position on 12 September 2023. The Council of the European Union adopted its general approach the proposal on 25 October. An informal agreement between the co-legislators on a compromise text for this file was reached on 14 December. This was formally endorsed by Parliament on 24 April 2024 and by the Council on 27 May. The Act was signed by the co-legislators on 13 June 2024 and published in the Official Journal on 17 July 2024. |
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| Source Link | Link to Main Source http://data.europa.eu/eli/reg/2024/1938/oj |
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| Subject Categories | Health |
| Subject Tags | Public Health |
| International Organisations | European Union [EU] |
