Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
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: 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 8 October 2026
- ✓ Committee work Report adopted 19 March 2024
- ✓ Tabled for plenary 21 March 2024
- ✓ Plenary vote Adopted 10 April 2024
- 5 Negotiations with the Council Deal approved in committee 18 March 2026
- 6 Published as law
How a file moves through Parliament
A file is referred to one lead committee (others may give an opinion). Its rapporteur writes a draft report, committee members table amendments, and the committee votes to adopt the report. The report is then tabled for all MEPs; political groups can table further amendments, which are voted on before the final vote in plenary. For a law, Parliament’s adopted text is its first-reading position; Parliament and the Council then negotiate a common text (trilogues) which both must approve before it is published as law.
Who is working on it
- Lead committee
- SANT — Public Health
- Rapporteurs
- MEP #197515 PPEDolors MONTSERRAT PPE
- Shadow rapporteurs
- Monika BEŇOVÁ S&DMEP #247122 RenewMEP #28161 Verts/ALEMEP #197530 ECRMEP #197806 IDKateřina KONEČNÁ The LeftNicolás GONZÁLEZ CASARES S&DMargarita DE LA PISA CARRIÓN PfEKristoffer STORM ECRVlad VASILE-VOICULESCU RenewTilly METZ Verts/ALEGiorgos GEORGIOU The LeftChristine ANDERSON ESN
- For opinion
- IMCO — Internal Market and Consumer Protection BUDG — Budgets ITRE — Industry, Research and Energy · rapporteur MEP #124726 PPE
The rapporteur drafts and negotiates the text for the lead committee; each other political group names a shadow rapporteur to follow the file.
The text, version by version
Committee opinions: Opinion (ITRE),Draft opinion (ITRE)
Newest version first. Open a version to read it in full. “What changed” shows the differences paragraph by paragraph; ✦ lines are AI-written from the texts themselves.
Timeline
- Committee stage
- 12 October 2026 Draft report published
The rapporteur’s first text in SANT (Public Health). Members can table amendments before the committee votes.
- 8 October 2026 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.
- Negotiations with the Council
- 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
- 10 April 2024 Plenary voteAdopted Adopted by an overwhelming majorityFor 495 Against 57 Abstained 45
Final vote at 19:19 · 83% of votes cast in favour · every MEP’s position →
Show all 19 ballots in voting order
1. Amendments by the committee responsible — put to the vote collectively Amendments by the committee responsible – put to the vote collectivelyAdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded2. Amendments by the committee responsible — separate vote Amendments by the committee responsible – separate voteAdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded3. Amendments by the committee responsible — separate vote Amendments by the committee responsible – separate voteAdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded4. Amendment 85 19:17 A9-0140/2024 – Pernille Weiss – Amendments by the committee responsible – separate vote – Am 85Adopted5. Amendment 159 — part 1 19:17 A9-0140/2024 – Pernille Weiss – Amendments by the committee responsible – separate vote – Am 159/1Adopted6. Amendment 159 — part 2 19:18 A9-0140/2024 – Pernille Weiss – Amendments by the committee responsible – separate vote – Am 159/2Adopted7. Separate vote on Article 3, paragraph 3RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded8. Separate vote on Article 3, paragraph 4RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded9. Amendment 343 to Article 63, paragraph 3 19:18 A9-0140/2024 – Pernille Weiss – Article 63, § 3 – Am 343Rejected10. Separate vote on Article 63, paragraph 3AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded11. Separate vote on Article 69, paragraph 2, subparagraph 2AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recordedNot put to a vote, because an earlier vote already settled the matter.13. Amendment 345 to Article 81, paragraph 1 19:18 A9-0140/2024 – Pernille Weiss – Article 81, § 1 – Am 345Rejected14. Separate vote on Article 81, paragraph 1AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded15. Amendment 346 to Article 82, paragraph 1, subparagraph 1 19:19 A9-0140/2024 – Pernille Weiss – Article 82, § 1, sub§ 1 – Am 346RejectedRejected17. Separate vote on recital 129RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded18. Separate vote on recital 129AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recordedAdopted - 10 April 2024 Debated in plenary
MEPs debated the text in the chamber ahead of the vote.
- 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
- 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.
- 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.