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

2023/0132(COD) · Ordinary legislative procedure

Procedure 2023/0132(COD) (ordinary legislative procedure) concerns “Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC”; the committee responsible is ENVI (Environment, Climate and Food Safety). Ongoing: Plenary vote scheduled for 25 Nov 2026.

Reference
2023/0132(COD)
Type
Ordinary legislative procedure
Status
Ongoing, 2nd reading
Lead
ENVI Environment, Climate and Food Safety
SANT Public Health
Associated
JURI Legal Affairs (opinion: Adrián Vázquez Lázara (Renew, Spain))
Opinion
BUDG Budgets
IMCO Internal Market and Consumer Protection
ITRE Industry, Research and Energy (opinion: Henna Virkkunen (EPP, Finland))
Rapporteur
Dolors Montserrat (EPP, Spain)
Shadow rapporteurs
Giorgos Georgiou (The Left, Cyprus), Tilly Metz (Greens/EFA, Luxembourg), Nicolás González Casares (S&D, Spain), Vlad Vasile-Voiculescu (Renew, Romania), Kristoffer Storm (ECR, Denmark), Margarita de la Pisa Carrión (PfE, Spain), Christine Anderson (ESN, Germany)
Earlier terms
Rapporteur: Pernille Weiss-Ehler (EPP, Denmark)
Shadows: Kateřina Konečná (The Left, Czechia), Margrete Auken (Greens/EFA, Denmark), Monika Beňová (S&D, Slovakia), Catherine Amalric (Renew, France), Joanna Kopcińska (ECR, Poland), Annalisa Tardino (ID, Italy)
Opinions
4 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. 15 May 2023: Appointment of a rapporteur

1st reading

  1. 14 Sep 2023: Proposal referred to plenary
  2. 3 Oct 2023: Parliamentary committee tabling report
  3. 13 Feb 2024: Parliamentary committee adopting an opinion
  4. 22 Feb 2024: Parliamentary committee adopting an opinion
  5. 19 Mar 2024: Adoption of a report by the EP committee responsible
  6. 21 Mar 2024: Tabling of a document to European Parliament plenary sitting
  7. 10 Apr 2024: Debates in European Parliament plenary sitting; Vote in European Parliament plenary sitting; EP position at 1st reading with amendments
  8. 19 Feb 2025: Appointment of a rapporteur
  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.