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.
![]() |
Proposed Replacement EU Act |
---|---|
![]() |
Article 13(3) |
![]() |
|
![]() |
UK Government Explanatory Memorandum on the proposed act – 10 July 2023 (PDF, 6 pages, 91KB)
Information considered by 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. |
![]() |
The DSC heard evidence from departmental officials on 22 May 2025 and is seeking views from stakeholders via Citizen Space - take part in the online survey. [External link] |
![]() 2-month scrutiny period starts |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |
![]() |
N/A |