Sittings · Procedure

2023/0131(COD) Ordinary legislative procedure First 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

Text versions

Committee draft ENVI-PR-753550 2023-10-20⇄ diff Tabled text A-9-2024-0141 2024-03-21⇄ diff Tabled text ITRE-AD-754772 2024-02-22⇄ diff Tabled text AGRI-AL-757314 2024-01-17⇄ diff Tabled text ITRE-PA-754772 2023-11-08⇄ diff Tabled text BUDG-AL-759054 2024-02-23⇄ diff Tabled text SP-2024-377-TA-9-2024-0221 2024-07-29⇄ diff Adopted text TA-9-2024-0221 2024-04-10

Timeline

  1. 2026-03-18
    Committee approve provisional agreement
  2. 2025-12-10
    Interinstitutional negotiation
  3. 2025-11-11
    Interinstitutional negotiation
  4. 2025-10-07
    Interinstitutional negotiation
  5. 2025-06-17
    Interinstitutional negotiation
  6. 2024-04-10
    Plenary debate sitting 2024-04-10 📄 A-9-2024-0141📄 A-9-2024-0140📄 C-9-2023-0144📄 C-9-2023-0143
  7. 2024-04-10
    Plenary amend proposal
  8. 2024-04-10
    Plenary vote sitting 2024-04-10 📄 A-9-2024-0141
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    A9-0141/2024 – Tiemo Wölken – After Article 40 – Am 379
    Rejected
    Article 31, § 1, introductory part vote hand — no individual record
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Article 35, § 1, point a vote hand — no individual record
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Article 31, § 1, point b vote hand — no individual record
    Rejected
    Amendments by the committee responsible – separate vote vote electronic — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Article 33, § 2 vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    A9-0141/2024 – Tiemo Wölken – After recital 5 – Am 368
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Article 30, § 3 vote hand — no individual record
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    A9-0141/2024 – Tiemo Wölken – Article 33, § 3 – Am 373
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Article 34, § 1 vote hand — no individual record
    Rejected
    Article 33, after § 3 vote hand — no individual record
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    A9-0141/2024 – Tiemo Wölken – Commission proposal
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    A9-0141/2024 – Tiemo Wölken – After recital 3 – Am 377
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    A9-0141/2024 – Tiemo Wölken – Article 134, before § 1 – Am 378
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – put to the vote collectively vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Article 33, § 2 vote hand — no individual record
    Rejected
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
    Amendments by the committee responsible – separate vote vote hand — no individual record
    Adopted
  9. 2024-04-10
    Plenary vote sitting 2024-04-10
  10. 2024-03-21
    Tabled for plenary 📄 A-9-2024-0141
  11. 2024-03-19
    Report adopted in committee
  12. 2024-02-22
    Committee adopting opinion
  13. 2024-02-14
    Committee adopting opinion
  14. 2024-01-24
    Committee adopting opinion
  15. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756133
  16. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756136
  17. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756134
  18. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756132
  19. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756137
  20. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756138
  21. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756131
  22. 2023-11-21
    Committee amendments tabled 📄 ENVI-AM-756135
  23. 2023-10-20
    Committee draft report 📄 ENVI-PR-753550
  24. 2023-09-14
    Referral to committee