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

2023/0131(COD) · Ordinary legislative procedure

Procedure 2023/0131(COD) (ordinary legislative procedure) concerns “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”; the committee responsible is ENVI (Environment, Climate and Food Safety). Ongoing: Plenary vote scheduled for 25 Nov 2026.

Reference
2023/0131(COD)
Type
Ordinary legislative procedure
Status
Ongoing, 2nd reading
Lead
ENVI Environment, Climate and Food Safety
SANT Public Health
Associated
ITRE Industry, Research and Energy (opinion: Henna Virkkunen (EPP, Finland))
Opinion
AGRI Agriculture and Rural Development (opinion: Norbert Lins (EPP, Germany))
BUDG Budgets (opinion: Johan Van Overtveldt (ECR, Belgium))
CONT Budgetary Control
IMCO Internal Market and Consumer Protection
LIBE Civil Liberties, Justice and Home Affairs
Shadow rapporteurs
Giorgos Georgiou (The Left, Cyprus), Stine Bosse (Renew, Denmark), Michele Picaro (ECR, Italy), Margarita de la Pisa Carrión (PfE, Spain), Christine Anderson (ESN, Germany)
Earlier terms
Rapporteur: Tiemo Wölken (S&D, Germany)
Shadows: Kateřina Konečná (The Left, Czechia), Tilly Metz (Greens/EFA, Luxembourg), Frédérique Ries (Renew, Belgium), Tomislav Sokol (EPP, Croatia), Andrey Slabakov (ECR, Bulgaria), Anders Vistisen (ID, Denmark)
Opinions
5 shadow rapporteurs in the committees for opinion

Votes in the Council of the EU

  • 28 Sep 2026: Council (Agriculture and Fisheries), Adoption of a Council's position (at first reading) and Adoption of the statement of the Council's reasons: adopted; Member states: 26 for, 0 against, 1 abstention. Abstained: Malta. Result at the Council of the EU

Timeline

  1. 11 May 2023: Appointment of a rapporteur

1st reading

  1. 14 Sep 2023: Proposal referred to plenary
  2. 20 Oct 2023: Parliamentary committee tabling report
  3. 24 Jan 2024: Parliamentary committee adopting an opinion
  4. 14 Feb 2024: Parliamentary committee adopting an opinion
  5. 22 Feb 2024: Parliamentary committee adopting an opinion
  6. 19 Mar 2024: Adoption of a report by the EP committee responsible
  7. 21 Mar 2024: Tabling of a document to European Parliament plenary sitting
  8. 10 Apr 2024: Debates in European Parliament plenary sitting; Plenary vote results; EP position at 1st reading with amendments
  9. 17 Jun 2025: Interinstitutional negotiation (4 times, most recently on 10 Dec 2025)
  10. 18 Mar 2026: Approval of the provisional agreement with the Council by the EP committee responsible

2nd reading

  1. 8 Oct 2026: Proposal referred to plenary
  2. 12 Oct 2026: Parliamentary committee tabling report
  3. 25 Nov 2026 (scheduled): Vote in plenary, provisional according to the agenda

Source: European Parliament, Open Data Portal (procedures, agendas, roll-call votes), CC BY 4.0, prepared by OpenRCV. Votes in the Council: Council of the European Union, voting results (consilium.europa.eu), reused with acknowledgement of the source under Decision (EU) 2017/1842; population figures from the Council’s Rules of Procedure (Annex III, Official Journal of the EU). Procedure file in the Legislative Observatory (OEIL)

Source: European Parliament, Open Data Portal (procedures, agendas, roll-call votes), CC BY 4.0. Names of steps, roles and procedure types from the European Parliament’s vocabulary.