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2023/0131(COD)COM(2023)193ENVI

Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency

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

Stage
Council adoption, reached 6 Mar 2026
Procedure
Regulation · Ordinary legislative procedure
Rapporteur
Tiemo Wölken (S&D)
Lead DG
DG SANTE
Commissioner
Olivér Várhelyi
Council configuration
Employment, Social Policy, Health and Consumer Affairs Council
Last activity
18 Mar 2026
Legal basis
TFEU_2016 Art. 114; TFEU_2016 Art. 168; TFEU_2016 Art. 168(4); TFEU_2016 Art. 294
62 entries · record as of 14 Sept 2026

Where it stands

Latest: Approval of the provisional agreement with the Council by the EP committee responsible, 18 Mar 2026. Next: Council’s position at first reading and statement of reasons, 28 Sept 2026.

Show the earlier record: 47 dates, 26 Apr 2023 to 21 Oct 2025
  1. 26 Apr 2023
    • Adoption of legislative proposal by the Commission
  2. 28 Apr 2023
    • Discussions within the Council or its preparatory bodies
  3. 22 Jun 2023
    • Discussions within the Council or its preparatory bodies
  4. 14 Sept 2023
    • Referred to committee
  5. 20 Oct 2023
    • Committee report tabled
    • EP committee draft report
  6. 27 Oct 2023
    • Discussions within the Council or its preparatory bodies
  7. 8 Nov 2023
    • Committee opinion tabled
  8. 10 Nov 2023
    • Discussions within the Council or its preparatory bodies
  9. 21 Nov 2023
    • Committee amendments tabled
    • Tabling of amendments in the EP committee responsible
  10. 23 Nov 2023
    • Discussions within the Council or its preparatory bodies
  11. 29 Nov 2023
    • Discussions within the Council or its preparatory bodies
  12. 8 Dec 2023
    • Discussions within the Council or its preparatory bodies
  13. 9 Jan 2024
    • Discussions within the Council or its preparatory bodies
  14. 24 Jan 2024
    • Committee opinion adopted
  15. 14 Feb 2024
    • Committee opinion adopted
  16. 22 Feb 2024
    • Committee opinion adopted
  17. 19 Mar 2024
    • Committee report adopted
  18. 21 Mar 2024
    • Tabled for plenary
  19. 10 Apr 2024
    • EP position at first reading
    • Plenary amended the proposal
    • Plenary vote
    • Debate in plenary
  20. 2 Jul 2024
    • Discussions within the Council or its preparatory bodies
  21. 13 Nov 2024
    • Referred to committee
  22. 20 Nov 2024
    • Deliberations in Coreper
  23. 22 Nov 2024
    • Deliberations in Coreper
  24. 3 Dec 2024
    • Deliberations in Council
  25. 18 Dec 2024
    • Deliberations in Coreper
  26. 3 Apr 2025
    • Deliberations in Council working party
  27. 8 Apr 2025
    • Deliberations in Council working party
  28. 15 Apr 2025
    • Deliberations in Council working party
  29. 28 Apr 2025
    • Deliberations in Council working party
  30. 5 May 2025
    • Deliberations in Council working party
  31. 6 May 2025
    • Deliberations in Council working party
  32. 12 May 2025
    • Deliberations in Council working party
  33. 14 May 2025
    • Adoption of negotiating mandate by Coreper
  34. 21 May 2025
    • Adoption of negotiating mandate by Coreper
  35. 4 Jun 2025
    • Adoption of negotiating mandate by Coreper
  36. 17 Jun 2025
    • Interinstitutional negotiations
  37. 20 Jun 2025
    • Deliberations in Council
  38. 24 Jun 2025
    • Deliberations in Council working party
  39. 25 Jun 2025
    • Deliberations in Coreper
  40. 9 Jul 2025
    • Deliberations in Council working party
  41. 3 Sept 2025
    • Deliberations in Council working party
  42. 22 Sept 2025
    • Deliberations in Council working party
  43. 25 Sept 2025
    • Deliberations in Council working party
  44. 1 Oct 2025
    • Deliberations in Coreper
  45. 7 Oct 2025
    • Interinstitutional negotiations
  46. 15 Oct 2025
    • Deliberations in Coreper
  47. 21 Oct 2025
    • Retained as a pending proposal in the Commission work programme · Commission
  1. 7 Nov 2025
    • Deliberations in Coreper
  2. 11 Nov 2025
    • Interinstitutional negotiations
  3. 14 Nov 2025
    • Deliberations in Coreper
  4. 3 Dec 2025
    • Deliberations in Coreper
  5. 10 Dec 2025
    • Interinstitutional negotiations
  6. 19 Dec 2025
    • Deliberations in Coreper
  7. 6 Mar 2026
    • Endorsement of the provisional agreement by Coreper · Council
  8. 18 Mar 2026
    • Approval of the provisional agreement with the Council by the EP committee responsible · Parliament committee
    • Committee approved the provisional agreement
  1. 28 Sept 2026Scheduled
    • Council’s position at first reading and statement of reasons · Council
14 people

Who is on it

The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.

RoleNameGroupCountryCommittee
RapporteurTiemo WölkenS&DDEENVI
Shadow rapporteurChristine AndersonESNDE
Shadow rapporteurGiorgos GeorgiouThe LeftCY
Shadow rapporteurMargarita de la Pisa CarriónPfEES
Shadow rapporteurMichele PicaroECRIT
Shadow rapporteurStine BosseRenewDK
Shadow rapporteurTilly MetzGreens/EFALU
Shadow rapporteurTomislav SokolEPPHR
Rapporteur for opinionNorbert LinsEPPDEAGRI
Rapporteur for opinionJohan Van OvertveldtECRBEBUDG
Rapporteur for opinionHenna VirkkunenEPPFIITRE
Shadow rapporteur for opinionLuke Ming FlanaganThe LeftIE
Shadow rapporteur for opinionSusana Solís PérezRenewESITRE
Shadow rapporteur for opinionVille NiinistöGreens/EFAFIITRE
2,225 amendments

Amendments

Tabled between 21 Nov 2023 and 30 Nov 2023. The texts are in the amendment documents below.

By committee

  • ENVI1,726
  • ITRE499

By author

  • Susana Solís Pérez296
  • Tilly Metz252
  • Billy Kelleher187
  • Tomislav Sokol172
  • Margarita de la Pisa Carrión · ECR92
  • Laura Ballarín Cereza89
  • Nicolás González Casares87
  • Kateřina Konečná85
  • Ondřej Knotek67
  • Tiemo Wölken61
Show 17 more authors
  • Ville Niinistö · Verts/ALE61
  • Anders Vistisen · ID59
  • Fulvio Martusciello58
  • Andreas Glück45
  • Massimiliano Salini43
  • Dolors Montserrat37
  • Pilar del Castillo Vera28
  • Peter Liese23
  • Jessica Polfjärd22
  • Alessandra Moretti18
  • Sunčana Glavak17
  • Sirpa Pietikäinen16
  • Pietro Fiocchi13
  • Aldo Patriciello12
  • Henna Virkkunen6
  • András Gyürk2
  • Ernő SCHALLER-BAROSS2

Amendments each member tabled or co-signed. The record names an author on 1,548 of the 2,225 amendments.

By article

  • Article 71 – paragraph 2 – point a25
  • Article 71 – paragraph 2 – point b23
  • Article 116 – paragraph 1 – point d19
  • Article 117 – paragraph 118
  • Article 15 – paragraph 1 – point d16
  • Article 71 – paragraph 2 – point c15
  • Article 72 – paragraph 1 – subparagraph 115
  • Article 60 – paragraph 1 – introductory part14
  • Article 72 – paragraph 2 – subparagraph 114
  • Article 134 – paragraph 213
Show 20 more provisions
  • Article 162 – paragraph 213
  • Article 122 – paragraph 612
  • Article 131 – paragraph 112
  • Article 132 – paragraph 112
  • Article 150 – paragraph 2 – subparagraph 112
  • Article 40 a (new)12
  • Article 43 – paragraph 112
  • Recital 13812
  • Recital 3612
  • Article 6 – paragraph 2 – subparagraph 111
  • Article 60 – paragraph 1 – point b11
  • Article 70 – paragraph 1 – point b11
  • Article 72 – paragraph 1 – subparagraph 211
  • Recital 13311
  • Recital 13611
  • Article 130 – paragraph 1 – subparagraph 1 – introductory part10
  • Article 130 – paragraph 1 – subparagraph 1 – point a10
  • Article 19 – paragraph 310
  • Article 2 – paragraph 2 – point 11 a (new)10
  • Article 113 – paragraph 4 – subparagraph 19

Covers 396 of the 2,225 amendments.

17 documents

Documents

Newest first. Each opens at its source.

Summary

Generated

This regulation consolidates and replaces multiple prior acts to create a unified EU framework for authorizing and supervising human medicinal products, while defining the European Medicines Agency's operational rules. It streamlines market approval processes to ensure consistent public health protection and technical standards.

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Sources: EP Legislative Observatory · EU Law Tracker. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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