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Dossier · Ordinary legislative procedure

Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

Reference
2023/0132(COD) Ordinary legislative procedure
Where it stands
Parliament’s committee approved the deal reached with the Council on 18 March 2026; the plenary vote on it is still to come.
Stage
First reading
Lead committee
Public Health SANT
More facts (5)
Rapporteurs
MEP #197515, Dolors MONTSERRAT
Shadow rapporteurs
13 members
Decisions in plenary
None yet
Versions
3 versions
Opinions from
IMCO, BUDG, ITRE
More
Cite this page Legislative Observatory (opens the official site)
Link to this page

Where it stands

The steps of this kind of dossier and how far it has come, from the procedure file.

  1. Referred to committee (done) 14 September 2023
  2. Committee work (done) Report adopted 19 March 2024
  3. Tabled for plenary (done) 21 March 2024
  4. Plenary vote (done) Adopted 10 April 2024
  5. Negotiations with the Council (current step) Deal approved in committee 18 March 2026
  6. Published as law (to come)

A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.

People

Committees and members responsible for the dossier, as the procedure file names them. Groups as recorded there.

Lead committee
Public Health SANT
Rapporteurs
MEP #197515 (EPP) former member, Dolors MONTSERRAT (EPP)
Shadow rapporteurs
Monika BEŇOVÁ (S&D), MEP #247122 (Renew) former member, MEP #28161 (Greens) former member, MEP #197530 (ECR) former member, MEP #197806 (ID) former member, 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)
Opinion: IMCO
Internal Market and Consumer Protection
Opinion: BUDG
Budgets
Opinion: ITRE
Industry, Research and Energy · rapporteur MEP #124726 (EPP) former member

Decisions in plenary, 0

Every decision Parliament took on this dossier, newest first.

No plenary decision on this dossier is in the records yet.

Voting grid

Export

Every roll-call vote on the dossier, in date and voting order, with each group's line at the date of the vote.

No roll-call vote was recorded on this dossier.

Add members’ columns
The people on this dossier — pick up to 6. Each gets a column with their own position.

Versions, 3

The text of the dossier, version by version, newest first. Compare shows what changed between two consecutive versions.

  1. Adopted by Parliament10 Apr 2024

    Adopted text TA9-0220/2024 TA-9-2024-0220

    Compare with tabled for plenary

  2. Tabled for plenary21 Mar 2024

    Report A9-0140/2024 A-9-2024-0140

    Compare with committee draft

  3. Committee draft3 Oct 2023

    Draft report (ENVI) ENVI-PR-753470

AI: Each version in short Written by AI from the official text — check the source
  • Adopted text TA9-0220/2024: Parliament's amended version of a proposed directive on the Union code relating to medicinal products for human use, replacing Directive 2001/83/EC and Directive 2009/35/EC.
  • Report A9-0140/2024: Parliament's amended version of the Commission proposal for a directive on a Union code for medicinal products for human use, replacing Directive 2001/83/EC and Directive 2009/35/EC.
  • Draft report (ENVI): This is the rapporteur's draft report on the Commission proposal for a directive on a Union code for medicinal products for human use, replacing Directive 2001/83/EC and Directive 2009/35/EC.

Report a problem

Committee opinions: Opinion (ITRE), Draft opinion (ITRE)

What changed

Between consecutive versions of the text, newest pair first.

No overview of what changed between versions is available for this dossier. The “Compare” links under Versions show every change between two versions.

Timeline, 14

Every recorded step, newest first, grouped by stage; the latest stage is open.

Negotiations with the Council 5 steps · 17 Jun 2025–18 Mar 2026

  1. 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.

  2. 10 December 2025

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

  3. 11 November 2025

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

  4. 7 October 2025

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

  5. 17 June 2025

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

Plenary stage 3 steps · 21 Mar 2024–10 Apr 2024

  1. 10 April 2024

    Plenary vote

    Sitting of 10 Apr 2024 Adopted text TA9-0220/2024Report A9-0140/2024

  2. 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

  3. 21 March 2024

    Report tabled for plenary

    This is the text all MEPs vote on. Political groups can still table amendments to it.

    Report A9-0140/2024

Committee stage 6 steps · 14 Sept 2023–19 Mar 2024

  1. 19 March 2024

    Committee vote: report adopted

    SANT (Public Health) voted on the amendments and adopted the report that goes to plenary.

  2. 22 February 2024

    ITRE (Industry, Research and Energy) adopted its opinion

    The opinion is attached to the report for the lead committee to consider.

    Opinion (ITRE)

  3. 13 February 2024

    Committee opinion adopted

    The opinion is attached to the report for the lead committee to consider.

    JURI-AL-758884

  4. 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)

  5. 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.

    Draft report (ENVI)

  6. 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.

Connections

Texts, decisions, people and other dossiers related to this one.

No connections found for this item.

Sources & citation

Where the facts on this page come from, and how to cite it.

Permalink
https://news.eu-parl.st-solutions.dev/dossiers/2023-0132
Official source
Data source
Licensed CC BY 4.0.
Retrieved
25 September 2026

Cite as

European Parliament (2026). “Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC”. Dossier. reference 2023/0132(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/dossiers/2023-0132 (retrieved 25 September 2026). Official source: Legislative Observatory (OEIL), 2023/0132(COD), https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2023%2F0132(COD). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX 
@misc{epw-dossier-2023-0132,
  author = {{European Parliament}},
  title = {{Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC}},
  year = {2026},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/dossiers/2023-0132}},
  url = {https://news.eu-parl.st-solutions.dev/dossiers/2023-0132},
  urldate = {2026-09-25},
  publisher = {EU Parl Watch Research},
  note = {Dossier. reference 2023/0132(COD). Official source: https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2023\%2F0132(COD). Data: European Parliament Open Data (CC BY 4.0)}
}