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Files/2023/0131(COD)
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.

Follow all site updates (RSS)Open official fileEUR-Lex legal text

Where it is now

EP 2nd Reading
Last movement
8 Oct 2026
Started
26 Apr 2023
Lead committees
SANT / ENVI
This file last checked · Helsinki time
10 Oct 2026, 06:28

Latest movement

The file was sent to a parliamentary committee

8 Oct 2026

Current stage updated

EP 2nd Reading

8 Oct 2026

Where this file is now

An ordinary EU law can be agreed at first reading. Second reading and conciliation are only needed if agreement has not been reached. EUvahti marks the current recorded step; the other steps below are possible stages, not confirmed events for this file.

  1. 1Commission Proposal26 Apr 2023
  2. 2EP Committee
  3. 3EP 1st Reading
  4. 4Council Position
  5. 5EP 2nd Reading · If needed · Current recorded stepLast dated movement: 8 Oct 2026
  6. 6Conciliation · If needed
  7. 7Adopted
  8. 8Published in OJ
1
Commission Proposal
26 Apr 2023
2
EP Committee
3
EP 1st Reading
4
Council Position
5
EP 2nd Reading · If needed · Current
8 Oct 2026
6
Conciliation · If needed
7
Adopted
8
Published in OJ

EP 2nd Reading

Parliament is examining the Council position at second reading.

Show the complete Parliament activity record
The file was sent to a parliamentary committee
14 Sept 2023
The committee published a draft report
ENVIENVI-PR-75355020 Oct 2023
Committee amendments were tabled
ENVIENVI-AM-75613321 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613621 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613121 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613721 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613821 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613421 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613521 Nov 2023
Committee amendments were tabled
ENVIENVI-AM-75613221 Nov 2023
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
SANT-AG-79222718 Mar 2026
The file was sent to a parliamentary committee
8 Oct 2026

Official documents

EP report ENVI-PR-753550

EP report - 20 Oct 2023

Open

Committee opinion AGRI-AL-757314

Committee opinion - 24 Jan 2024

Open

Committee opinion BUDG-AL-759054

Committee opinion - 14 Feb 2024

Open

Committee opinion ITRE-AD-754772

Committee opinion - 22 Feb 2024

Open

EP resolution TA-9-2024-0221

EP resolution - 10 Apr 2024

Open

Provisional agreement SANT-AG-792227

Provisional agreement - 18 Mar 2026

Open

What happens next

Parliament is considering the file for a second time. Rejection or further negotiation is still possible.

Key facts

Procedure type
COD
Ordinary Legislative Procedure (co-decision)
Policy area
Environment & Climate
Parliament fileEUR-Lex legal text

Committees

CONT

Budgetary Control

LIBE

Civil Liberties, Justice and Home Affairs

BUDG

Budgets

SANT

Public Healthlead

ENVI

Environment, Public Health and Food Safetylead

ENVI-AM-756135

AGRI

Agriculture and Rural Development

IMCO

Internal Market and Consumer Protection

ITRE

Industry, Research and Energy

Topics

pharmaceuticalsmedicinesEMAhealthcareinnovationsupply security

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