Where the law stands, Dossier 2023/0131(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
Ordinary legislative procedure (COD): Parliament and the Council decide together as equals. · First reading
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
Where it stands
Negotiations with the Council
Parliament’s committee approved the deal reached with the Council on 18 March 2026; the plenary vote on it is still to come.
- Referred to committee(done) 14 September 2023
- Committee work(done) Report adopted 19 March 2024
- Tabled for plenary(done) 21 March 2024
- Plenary vote(done) Adopted 10 April 2024
- Negotiations with the Council Deal approved in committee 18 March 2026
- Published as law(to come)
No plenary decision on this dossier is in our records yet.
Who works on it
- Lead committee
- Environment, Climate and Food Safety
- The MEP who drafts the report and negotiates it on behalf of the committee.
- Tiemo Wölken (S&D)
- An MEP who follows a report on behalf of their own group when another group holds the rapporteur.
- Tomislav Sokol (EPP), Mep #4253 (Renew), Tilly Metz (Greens), Mep #197849 (ECR), Mep #124875 (ID), Kateřina Konečná (The Left), Margarita De La Pisa Carrión (Patriots), Michele Picaro (ECR), Stine Bosse (Renew), Giorgos Georgiou (The Left), Christine Anderson (ESN)
- Committees giving an opinion
- Budgetary Control
- Agriculture and Rural Development· rapporteurNorbert Lins (EPP)
- Internal Market and Consumer Protection
- Budgets· rapporteurJohan van Overtveldt (ECR)
- Civil Liberties, Justice and Home Affairs
The text, version by version
Newest first.
Adopted by Parliament· 10 Apr 2024
Tabled for plenary· 21 Mar 2024
Committee draft· 20 Oct 2023
Committee opinions: Opinion (ITRE), Draft opinion (ITRE)
Timeline
Newest first.
Negotiations with the Council 5 steps
18 March 2026
Committee approved the deal reached with the Council
The provisional agreement from the trilogues goes to the whole Parliament for a vote.
10 December 2025
Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
11 November 2025
Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
7 October 2025
Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
17 June 2025
Trilogue meeting
Negotiation between Parliament, Council and Commission on a common text.
Plenary stage 3 steps
10 April 2024
Plenary vote
Sitting of 10 Apr 2024 Adopted text TA9-0221/2024Report A9-0141/2024
10 April 2024
Debated in plenary
MEPs debated the text in the chamber ahead of the vote.
Sitting of 10 Apr 2024 Council / Commission text C9-0143/2023Council / Commission text C9-0144/2023Report A9-0140/2024Report A9-0141/2024
21 March 2024
Report tabled for plenary
This is the text all MEPs vote on. Political groups can still table amendments to it.
Committee stage 7 steps
19 March 2024
Committee vote: report adopted
ENVI (Environment, Climate and Food Safety) voted on the amendments and adopted the report that goes to plenary.
22 February 2024
ITRE (Industry, Research and Energy) adopted its opinion
The opinion is attached to the report for the lead committee to consider.
14 February 2024
Committee opinion adopted
The opinion is attached to the report for the lead committee to consider.
24 January 2024
Committee opinion adopted
The opinion is attached to the report for the lead committee to consider.
21 November 2023
Amendments tabled in committee (8 batches)
Members of ENVI (Environment, Climate and Food Safety) proposed changes to the draft.
Amendments in committee (ENVI)Amendments in committee (ENVI)Amendments in committee (ENVI)Amendments in committee (ENVI)Amendments in committee (ENVI)Amendments in committee (ENVI)Amendments in committee (ENVI)Amendments in committee (ENVI)
20 October 2023
Draft report published
The rapporteur’s first text in ENVI (Environment, Climate and Food Safety). Members can table amendments before the committee votes.
14 September 2023
Referred to the ENVI (Environment, Climate and Food Safety) committee
The lead committee prepares the report; CONT (Budgetary Control), AGRI (Agriculture and Rural Development), IMCO (Internal Market and Consumer Protection), BUDG (Budgets), LIBE (Civil Liberties, Justice and Home Affairs) give an opinion.
Official record: Legislative Observatory, 2023/0131(COD)