Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

Proposed Replacement EU Act

This law is a proposed 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 Assembly’s scrutiny of this proposed act.

➡️ Learn more about the terminology and information on this page.

➡️ Learn about the process for published replacement EU acts.

Category	Proposed Replacement EU Act
Procedure	Article 13(3)
Proposed EU law	Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 [External Link]
UK Government assessment and further information	UK Government Explanatory Memorandum on the proposed act – 10 July 2023 (PDF, 6 pages, 91KB)   Information considered by the Democratic Scrutiny Committee (DSC)
Date of notification of proposed EU Act to the Democratic Scrutiny Committee (DSC)	The DSC was not notified of the proposed EU act.   The proposed act was identified during the Committee's forward work planning exercise on 20 February 2025, when it considered proposed EU acts which had started their legislative passage before the Committee was established.
Consideration by the DSC of the proposed EU act	The DSC heard evidence from departmental officials on 22 May 2025 and sought views from stakeholders via Citizen Space.
Date of publication in Official Journal of the EU 2-month scrutiny period starts	N/A
Date of notification of published EU act to the DSC	N/A
Deadline for DSC decision on an inquiry	N/A
Decision to hold an inquiry	N/A
Deadline for publication of DSC Report	N/A
DSC report	N/A
Stormont Brake notification deadline	N/A
Stormont Brake notification	N/A
Consideration by UK Government (UKG)	N/A
UKG notification to European Commission	N/A
End of two-month scrutiny period	N/A