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2023/0132(COD)COM(2023)192SANT

Medicinal products for human use

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

Stage
Council adoption, reached 6 Mar 2026
Procedure
Directive · Ordinary legislative procedure
Rapporteurs
Pernille Weiss-ehler (EPP), Dolors Montserrat (EPP)
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. 114(1); TFEU_2016 Art. 168; TFEU_2016 Art. 168(4); TFEU_2016 Art. 294
61 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: 46 dates, 27 Apr 2021 to 15 Oct 2025
  1. 27 Apr 2021
    • Inception impact assessment closed: Evaluation and revision of the general pharmaceutical legislation, 173 responses · Commission
  2. 21 Dec 2021
    • Public consultation closed: Evaluation and revision of the general pharmaceutical legislation, 478 responses · Commission
  3. 26 Apr 2023
    • Adoption of legislative proposal by the Commission
  4. 28 Apr 2023
    • Discussions within the Council or its preparatory bodies
  5. 22 Jun 2023
    • Discussions within the Council or its preparatory bodies
  6. 14 Sept 2023
    • Referred to committee
  7. 3 Oct 2023
    • Committee report tabled
    • EP committee draft report
  8. 27 Oct 2023
    • Discussions within the Council or its preparatory bodies
  9. 7 Nov 2023
    • Committee opinion tabled
  10. 8 Nov 2023
    • Feedback on adopted proposal closed: Evaluation and revision of the general pharmaceutical legislation, 124 responses · Commission
  11. 21 Nov 2023
    • Committee amendments tabled
    • Tabling of amendments in the EP committee responsible
  12. 23 Nov 2023
    • Discussions within the Council or its preparatory bodies
  13. 29 Nov 2023
    • Discussions within the Council or its preparatory bodies
  14. 8 Dec 2023
    • Discussions within the Council or its preparatory bodies
  15. 8 Jan 2024
    • Discussions within the Council or its preparatory bodies
  16. 13 Feb 2024
    • Committee opinion adopted
  17. 22 Feb 2024
    • Committee opinion adopted
  18. 19 Mar 2024
    • Committee report adopted
  19. 21 Mar 2024
    • Tabled for plenary
  20. 10 Apr 2024
    • EP position at first reading
    • Plenary amended the proposal
    • Plenary vote
    • Debate in plenary
  21. 2 Jul 2024
    • Discussions within the Council or its preparatory bodies
  22. 13 Nov 2024
    • Referred to committee
  23. 20 Nov 2024
    • Deliberations in Coreper
  24. 22 Nov 2024
    • Deliberations in Coreper
  25. 3 Dec 2024
    • Deliberations in Council
  26. 18 Dec 2024
    • Deliberations in Coreper
  27. 3 Apr 2025
    • Deliberations in Council working party
  28. 8 Apr 2025
    • Deliberations in Council working party
  29. 15 Apr 2025
    • Deliberations in Council working party
  30. 28 Apr 2025
    • Deliberations in Council working party
  31. 5 May 2025
    • Deliberations in Council working party
  32. 6 May 2025
    • Deliberations in Council working party
  33. 12 May 2025
    • Deliberations in Council working party
  34. 14 May 2025
    • Adoption of negotiating mandate by Coreper
  35. 21 May 2025
    • Adoption of negotiating mandate by Coreper
  36. 4 Jun 2025
    • Adoption of negotiating mandate by Coreper
  37. 17 Jun 2025
    • Interinstitutional negotiations
  38. 20 Jun 2025
    • Deliberations in Council
  39. 24 Jun 2025
    • Deliberations in Council working party
  40. 25 Jun 2025
    • Deliberations in Coreper
  41. 9 Jul 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
  1. 21 Oct 2025
    • Retained as a pending proposal in the Commission work programme · Commission
  2. 7 Nov 2025
    • Deliberations in Coreper
  3. 11 Nov 2025
    • Interinstitutional negotiations
  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
RapporteurPernille Weiss-ehlerEPPDKENVI
RapporteurDolors MontserratEPPESSANT
Shadow rapporteurChristine AndersonESNDE
Shadow rapporteurGiorgos GeorgiouThe LeftCY
Shadow rapporteurKristoffer StormECRDK
Shadow rapporteurMargarita de la Pisa CarriónPfEES
Shadow rapporteurNicolás González CasaresS&DES
Shadow rapporteurTilly MetzGreens/EFALU
Shadow rapporteurVlad VASILE-VOICULESCURenewRO
Rapporteur for opinionHenna VirkkunenEPPFIITRE
Rapporteur for opinionAdrián Vázquez LázaraRenewESJURI
Shadow rapporteur for opinionNicolás González CasaresS&DESITRE
Shadow rapporteur for opinionSusana Solís PérezRenewESITRE
Shadow rapporteur for opinionVille NiinistöGreens/EFAFIITRE
2,239 amendments

Amendments

Tabled between 21 Nov 2023 and 1 Dec 2023. The texts are in the amendment documents below.

By committee

  • ENVI1,494
  • ITRE745

By author

  • Nicolás González Casares414
  • Tiemo Wölken252
  • Susana Solís Pérez192
  • Margarita de la Pisa Carrión · ECR180
  • Laura Ballarín Cereza168
  • Billy Kelleher95
  • Ville Niinistö · Verts/ALE74
  • Ondřej Knotek58
  • Kateřina Konečná52
  • Dolors Montserrat46
Show 20 more authors
  • Tomislav Sokol45
  • Pietro Fiocchi40
  • Massimiliano Salini38
  • Fulvio Martusciello37
  • Pilar del Castillo Vera37
  • Adam Jarubas35
  • Elżbieta Katarzyna Łukacijewska35
  • Ewa Kopacz35
  • Alessandra Moretti34
  • Sirpa Pietikäinen31
  • Asger Christensen26
  • Morten Løkkegaard26
  • Andreas Glück25
  • Peter Liese23
  • Heléne Fritzon18
  • András Gyürk15
  • Ernő SCHALLER-BAROSS15
  • Henna Virkkunen15
  • Jessica Polfjärd13
  • Sunčana Glavak11

Amendments each member tabled or co-signed. The record names an author on 1,412 of the 2,239 amendments.

By article

  • Article 63 – paragraph 329
  • Article 83 – paragraph 1 – point b25
  • Article 83 – paragraph 325
  • Article 83 – paragraph 1 – point a24
  • Article 63 – paragraph 523
  • Article 85 – paragraph 1 – point b20
  • Article 83 – paragraph 1 – introductory part18
  • Article 85 – paragraph 1 – point a – point iii18
  • Recital 6318
  • Article 81 – paragraph 117
Show 20 more provisions
  • Article 85 – paragraph 1 – point a – point i17
  • Article 195 – paragraph 216
  • Article 63 – paragraph 3 a (new)16
  • Article 63 – paragraph 616
  • Article 81 – paragraph 2 – subparagraph 1 – point c16
  • Article 84 – paragraph 1 – introductory part16
  • Article 85 – paragraph 1 – point a – introductory part16
  • Article 81 – paragraph 2 – subparagraph 1 – point b15
  • Article 85 – paragraph 1 – introductory part15
  • Recital 5015
  • Recital 6415
  • Article 22 – paragraph 314
  • Article 57 – paragraph 114
  • Article 80 – paragraph 414
  • Article 84 – paragraph 1 – point a14
  • Article 85 – paragraph 1 – point a – point ii14
  • Recital 7014
  • Article 2 – paragraph 112
  • Article 2 – paragraph 612
  • Article 47 – paragraph 1 – point d12

Covers 510 of the 2,239 amendments.

11 documents

Documents

Newest first. Each opens at its source.

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.

ConsultationFeedback deadlineFeedback received
8 Nov 20231,096

Summary

Generated

The new Union code for human medicinal products replaces Directives 2001/83/EC and 2009/35/EC, establishing a comprehensive legal framework to enhance public health security and streamline the internal market. It modernizes rules on innovation, supply chain safety, and labelling, with oversight by the European Medicines Agency.

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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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