2023/0131(COD)COD
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
Revises EU rules on the authorisation and supervision of medicinal products and updates the framework for the European Medicines Agency.
Latest movement
The committee approved a provisional agreement
Current stage updated
EP 1st Reading
Where this file is now
Commission Proposal
26 Apr 2023
EP Committee
3
EP 1st Reading
18 Mar 2026
4
Council Position
5
EP 2nd Reading
6
Conciliation
7
Adopted
8
Published in OJ
EP 1st Reading
Parliament is at first reading and may adopt, amend, or reject the proposal.
Show the complete Parliament activity record
The file was sent to a parliamentary committee
14 Sept 2023
The committee published a draft report
Committee amendments were tabled
Committee amendments were tabled
Committee amendments were tabled
Committee amendments were tabled
Committee amendments were tabled
Committee amendments were tabled
Committee amendments were tabled
Committee amendments were tabled
A committee adopted its opinion
AGRI-AL-75731424 Jan 2024
A committee adopted its opinion
BUDG-AL-75905414 Feb 2024
A committee adopted its opinion
ITRE-AD-75477222 Feb 2024
The committee adopted its report
19 Mar 2024
The file was scheduled for a plenary sitting
A-9-2024-014121 Mar 2024
Parliament voted on amendments
TA-9-2024-022110 Apr 2024
Plenary debate
A-9-2024-014110 Apr 2024
Parliament published the vote record
A-9-2024-014110 Apr 2024
Parliament held a plenary vote
10 Apr 2024
Negotiations with the Council began
17 Jun 2025
Negotiations with the Council began
7 Oct 2025
Negotiations with the Council began
11 Nov 2025
Negotiations with the Council began
10 Dec 2025
The committee approved a provisional agreement
18 Mar 2026
Official documents
EP report ENVI-PR-753550
EP report - 20 Oct 2023
Committee opinion AGRI-AL-757314
Committee opinion - 24 Jan 2024
Committee opinion BUDG-AL-759054
Committee opinion - 14 Feb 2024
Committee opinion ITRE-AD-754772
Committee opinion - 22 Feb 2024
EP resolution TA-9-2024-0221
EP resolution - 10 Apr 2024