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Dossier · Ordinary legislative procedure

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

Reference
2023/0131(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
Environment, Climate and Food Safety ENVI
More facts (5)
Rapporteur
Tiemo WÖLKEN
Shadow rapporteurs
11 members
Decisions in plenary
None yet
Versions
3 versions
Opinions from
CONT, AGRI, IMCO, BUDG, LIBE
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
Environment, Climate and Food Safety ENVI
Rapporteur
Tiemo WÖLKEN (S&D)
Shadow rapporteurs
Tomislav SOKOL (EPP), MEP #4253 (Renew) former member, Tilly METZ (Greens), MEP #197849 (ECR) former member, MEP #124875 (ID) former member, Kateřina KONEČNÁ (The Left), Margarita DE LA PISA CARRIÓN (Patriots), Michele PICARO (ECR), Stine BOSSE (Renew), Giorgos GEORGIOU (The Left), Christine ANDERSON (ESN)
Opinion: CONT
Budgetary Control
Opinion: AGRI
Agriculture and Rural Development · rapporteur Norbert LINS (EPP)
Opinion: IMCO
Internal Market and Consumer Protection
Opinion: BUDG
Budgets · rapporteur Johan VAN OVERTVELDT (ECR)
Opinion: LIBE
Civil Liberties, Justice and Home Affairs

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 TA9-0221/2024 TA-9-2024-0221

    Compare with tabled for plenary

  2. Tabled for plenary21 Mar 2024

    Report A9-0141/2024 A-9-2024-0141

    Compare with committee draft

  3. Committee draft20 Oct 2023

    Draft report (ENVI) ENVI-PR-753550

AI: Each version in short Written by AI from the official text — check the source
  • Adopted text TA9-0221/2024: Parliament's amended version of a proposed regulation sets out Union procedures for authorising and supervising human medicines and rules for the European Medicines Agency. It keeps the centralised procedure, simplifies the Agency's committees, and adds new rules on antimicrobial incentives, shortages and paediatric and orphan medicines.
  • Report A9-0141/2024: Parliament's amended version of the Commission proposal for a regulation on authorising and supervising human medicines and on the European Medicines Agency. It adds rules on medicine shortages, environmental risk assessment, antimicrobial incentives, orphan and paediatric medicines, transparency and regulatory sandboxes.

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, 15

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 TA9-0221/2024Report A9-0141/2024

  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 A9-0141/2024

Committee stage 7 steps · 14 Sept 2023–19 Mar 2024

  1. 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.

  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. 14 February 2024

    Committee opinion adopted

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

    BUDG-AL-759054

  4. 24 January 2024

    Committee opinion adopted

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

    AGRI-AL-757314

  5. 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)

  6. 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.

    Draft report (ENVI)

  7. 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.

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/2023-0131
Official source
Data source
Licensed CC BY 4.0.
Retrieved
25 September 2026

Cite as

European Parliament (2026). “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”. Dossier. reference 2023/0131(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/dossiers/2023-0131 (retrieved 25 September 2026). Official source: Legislative Observatory (OEIL), 2023/0131(COD), https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2023%2F0131(COD). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX 
@misc{epw-dossier-2023-0131,
  author = {{European Parliament}},
  title = {{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}},
  year = {2026},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/dossiers/2023-0131}},
  url = {https://news.eu-parl.st-solutions.dev/dossiers/2023-0131},
  urldate = {2026-09-25},
  publisher = {EU Parl Watch Research},
  note = {Dossier. reference 2023/0131(COD). Official source: https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2023\%2F0131(COD). Data: European Parliament Open Data (CC BY 4.0)}
}