P9_TA(2024)0353 – Standards of quality and safety for substances of human origin intended for human application – European Parliament legislative resolution of 24 April 2024 on the 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 (COM(2022)0338 – C9-0226/2022 – 2022/0216(COD)) (Ordinary legislative procedure: first reading)
Date: 2024-04-24
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: artificial reproduction, blood transfusion, cytology, health control, quality standard, safety standard, stem cell, substance of human origin, therapeutics




C_202503779EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/3779


17.9.2025






P9_TA(2024)0353

Standards of quality and safety for substances of human origin intended for human application


European Parliament legislative resolution of 24 April 2024 on the 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 (COM(2022)0338 – C9-0226/2022 – 2022/0216(COD))


(Ordinary legislative procedure: first reading)

(C/2025/3779)



The European Parliament,







—


having regard to the Commission proposal to Parliament and the Council (COM(2022)0338),










—


having regard to Article 294(2) and Article 168(4), point (a), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0226/2022),










—


having regard to Article 294(3) of the Treaty on the Functioning of the European Union,










—


having regard to the opinion of the European Economic and Social Committee of 27 October 2022
                   (1),










—


after consulting the Committee of the Regions,










—


having regard to the provisional agreement approved by the committee responsible under Rule 74(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 30 January 2024 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,










—


having regard to Rule 59 of its Rules of Procedure,










—


having regard to the report of the Committee on the Environment, Public Health and Food Safety (A9-0250/2023),










1.


Adopts its position at first reading hereinafter set out (2);










2.


Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;










3.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.







(1)  
            OJ C 75, 28.2.2023, p. 154.

(2)  This position replaces the amendments adopted on 12 September 2023 (Texts adopted, P9_TA(2023)0299).






P9_TC1-COD(2022)0216


Position of the European Parliament adopted at first reading on 24 April 2024 with a view to the adoption of Regulation (EU) 2024/… 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



(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2024/1938.)




ELI: http://data.europa.eu/eli/C/2025/3779/oj
ISSN 1977-091X (electronic edition)