Ordinary legislative procedure (COD): Parliament and the Council decide together as equals. Ordinary legislative procedure Second reading
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
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
- ENVI — Environment, Climate and Food Safety
- Rapporteur
- Tiemo WÖLKEN S&D
- Shadow rapporteurs
- Tomislav SOKOL PPEMEP #4253 RenewTilly METZ Verts/ALEMEP #197849 ECRMEP #124875 IDKateřina KONEČNÁ The LeftMargarita DE LA PISA CARRIÓN PfEMichele PICARO ECRStine BOSSE RenewGiorgos GEORGIOU The LeftChristine ANDERSON ESN
- For opinion
- CONT — Budgetary Control AGRI — Agriculture and Rural Development · rapporteur Norbert LINS PPEIMCO — Internal Market and Consumer Protection BUDG — Budgets · rapporteur Johan VAN OVERTVELDT ECRLIBE — Civil Liberties, Justice and Home Affairs
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
Adopted by Parliament · latest Adopted text TA9-0221/2024 10 April 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.⇄ what changed Tabled for plenary Report A9-0141/2024 21 March 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.⇄ what changed Committee draft Draft report (SANT) 12 October 2026 ✦ This is the rapporteur's draft report on the Council's first-reading position for a regulation on Union procedures for authorising and supervising medicinal products for human use and on rules for the European Medicines Agency. It recommends that Parliament approve the Council position.⇄ what changed Committee draft Draft report (ENVI) 20 October 2023 ✦ The rapporteur's draft report sets out Parliament's first-reading position on the proposed regulation on authorising and supervising human medicines and on the European Medicines Agency. It amends many provisions and deletes the transferable data exclusivity voucher for priority antimicrobials, replacing it with a new European Medicines Facility.
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 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.
- 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 488 Against 67 Abstained 34
Final vote at 19:23 · 83% of votes cast in favour · every MEP’s position →
Show all 40 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. 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 recorded5. 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 recorded6. 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 recorded7. 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 recorded8. 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 recorded9. 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 recorded10. 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 recorded11. Amendments by the committee responsible — separate vote Amendments by the committee responsible – separate voteAdoptedelectronic vote (totals only) — no individual positions recorded12. 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 recorded13. 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 recorded14. 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 recorded15. 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 recorded16. 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 recorded17. 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 recorded18. 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 recorded19. 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 recorded20. 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 recorded21. 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 recorded22. 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 recorded23. 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 recorded24. 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 recorded25. 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 recorded26. 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 recorded27. Separate vote on Article 30, paragraph 3RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded28. Separate vote on Article 31, paragraph 1, introductory partRejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded29. Separate vote on Article 31, paragraph 1, point bRejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded30. Separate vote on Article 33, paragraph 2RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded31. Separate vote on Article 33, paragraph 2AdoptedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded32. Amendment 373 to Article 33, paragraph 3 19:22 A9-0141/2024 – Tiemo Wölken – Article 33, § 3 – Am 373Rejected33. Separate vote on Article 33, after paragraph 3RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded34. Separate vote on Article 34, paragraph 1RejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded35. Separate vote on Article 35, paragraph 1, point aRejectedA vote by raised hands. Only the outcome is recorded, not who voted how. — no individual positions recorded36. Amendment 379, adding text after Article 40 19:22 A9-0141/2024 – Tiemo Wölken – After Article 40 – Am 379Rejected37. Amendment 378 to Article 134, before paragraph 1 19:22 A9-0141/2024 – Tiemo Wölken – Article 134, before § 1 – Am 378Rejected38. Amendment 377, adding text after recital 3 19:22 A9-0141/2024 – Tiemo Wölken – After recital 3 – Am 377Rejected39. Amendment 368, adding text after recital 5 19:23 A9-0141/2024 – Tiemo Wölken – After recital 5 – Am 368RejectedAdopted - 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
ENVI (Environment, Climate and Food Safety) 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.
- 14 February 2024 Committee opinion adopted
The opinion is attached to the report for the lead committee to consider.
- 24 January 2024 Committee opinion adopted
The opinion is attached to the report for the lead committee to consider.
- 21 November 2023 Amendments tabled in committee (8 batches)
Members of ENVI (Environment, Climate and Food Safety) proposed changes to the draft.
- 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.
- 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.