Regulation 2024/1938 - Standards of quality and safety for substances of human origin intended for human application - Main contents
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official title
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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2024/1938 |
| Original proposal | COM(2022)338  |
| CELEX number i | 32024R1938 |
| Document | 13-06-2024; Date of signature |
|---|---|
| Signature | 13-06-2024 |
| Effect | 06-08-2024; Entry into force Date pub. +20 See Art 87.1 07-08-2024; Application Partial application See Art 87.2 07-08-2027; Application See Art 87.1 07-08-2028; Application Partial application See Art 87.2 |
| Deadline | 06-08-2024; See Art 77.2 And 87.2 08-08-2029; See Art 86 |
| End of validity | 31-12-9999 |
Official Journal of the European Union |
EN L series |
2024/1938 |
17.7.2024 |
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(4), point (a), thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
According to Article 168(1), first subparagraph, of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. |
(2) |
Article 168(4), point (a), TFEU provides that the European Parliament and the Council is to adopt measures setting high standards of quality and safety for organs and substances of human origin (SoHO), blood and blood derivatives. Furthermore, Member States are not to be prevented from maintaining or introducing more stringent protective measures. |
(3) |
According to Article 168(7) TFEU, Union action is to respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. Measures adopted pursuant to Article 168(4), point (a), TFEU are not to affect national provisions on the donation or medical use of organs and blood. |
(4) |
As regards Article 168(4), point (a), TFEU, high standards for the quality and safety of organs and SoHO, blood and blood derivatives are to ensure a high level of human health protection. Therefore, this Regulation aims at setting high quality and safety standards by ensuring, inter alia, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHO, and of SoHO recipients and offspring from medically assisted reproduction, as well as by providing for measures to monitor and support the sufficiency of the supply of SoHO that are critical for the health of patients. In accordance with Article 3 of the Charter, those safety standards are to be based on the fundamental principle that the human body or its parts as such are not to be a source of financial gain. |
(5) |
Directives 2002/98/EC (3) and 2004/23/EC (4) of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and blood components and for tissues and cells, respectively. Although those Directives have harmonised to a certain degree the rules of Member States in the area of quality and safety of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This has resulted in divergences between national rules, which can create obstacles to cross-border sharing of such substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for such substances, which achieves quality and safety of all SoHO, enhances legal certainty for patients and stakeholders involved and supports continuous supply, including the cross-border exchange of SoHO, whilst facilitating innovation for the benefit of public health. In order to achieve a coherent application of the... |
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