Where the law stands, Dossier 2023/0132(COD)
Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
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
- Public Health
- The MEP who drafts the report and negotiates it on behalf of the committee.
- Mep #197515 (EPP), Dolors Montserrat (EPP)
- An MEP who follows a report on behalf of their own group when another group holds the rapporteur.
- Monika Beňová (S&D), Mep #247122 (Renew), Mep #28161 (Greens), Mep #197530 (ECR), Mep #197806 (ID), Kateřina Konečná (The Left), Nicolás González Casares (S&D), Margarita De La Pisa Carrión (Patriots), Kristoffer Storm (ECR), Vlad Vasile-Voiculescu (Renew), Tilly Metz (Greens), Giorgos Georgiou (The Left), Christine Anderson (ESN)
- Committees giving an opinion
- Internal Market and Consumer Protection
- Budgets
- Industry, Research and Energy· rapporteurMep #124726 (EPP)
The text, version by version
Newest first.
Adopted by Parliament· 10 Apr 2024
Tabled for plenary· 21 Mar 2024
Committee draft· 3 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 TA9-0220/2024Report A9-0140/2024
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 6 steps
19 March 2024
Committee vote: report adopted
SANT (Public Health) 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.
13 February 2024
Committee opinion adopted
The opinion is attached to the report for the lead committee to consider.
21 November 2023
Amendments tabled in committee (4 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)
3 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 SANT (Public Health) committee
The lead committee prepares the report; IMCO (Internal Market and Consumer Protection), BUDG (Budgets), ITRE (Industry, Research and Energy) give an opinion.
Official record: Legislative Observatory, 2023/0132(COD)