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

Published Replacement EU Act

This law is a published replacement EU law: Article 13(3a) applies and the Stormont Brake could be used under certain circumstances. Read more about the procedure for new and amending/replacement EU laws and how they apply in Northern Ireland.

The table below sets out the main procedural steps and the work of the Democratic Scrutiny Committee (DSC) in relation to this act.

Category	Published Replacement EU Act
Procedure	Article 13(3)
EU law	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 [External link]
UK Government assessment and further information	UK Government Explanatory Memorandum on published EU act - 24 July 2024 [PDF, 15 pages, 269KB] UK Government Explanatory Memorandum on proposed EU act – 28 September 2022 [PDF, 7 pages, 180KB] Information considered by the Democratic Scrutiny Committee
Date of publication in the Official Journal of the EU 2-month scrutiny period starts	17/07/2024
Date of notification to the Democratic Scrutiny Committee (DSC)	18/07/2024
Deadline for DSC decision on an inquiry	25/07/2024
Decision to hold an inquiry	At its meeting of 25 July 2024, the Committee decided to hold an inquiry into the replacement EU act.
Deadline for publication of DSC Report	27/08/2024
DSC report	DSC report on Regulation (EU) 2024/1938
Stormont Brake notification deadline	03/09/2024
Stormont Brake notification	A notification was not received by the Speaker.
Consideration by UK Government (UKG)	N/A
UKG notification to European Commission	N/A
End of two-month scrutiny period	17/09/2024