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Bill · COD

2023/0132(COD)

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

Original

votedEuropean Union· European Parliament· EN

Introduced

14 September 2023

Last action

18 March 2026 · committee approve provisional agreement

Status

PLENARY_VOTE

Sponsors

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Subjects

Discovery layer

Source updated

18 March 2026

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Official titles

Authentic titles published by the source. The stored canonical title is not replaced.

23 official languages
  • Bulgarian

    Кодекс на Съюза за лекарствените продукти за хуманна употреба и отмяна на Директива 2001/83/ЕО и Директива 2009/35/ЕО

  • Czech

    Kodex Unie o humánních léčivých přípravcích a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES

  • Danish

    EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF

  • German

    Schaffung eines Unionskodexes für Humanarzneimittel und Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG

  • Greek

    Ενωσιακός κώδικας που αφορά φάρμακα για ανθρώπινη χρήση, και κατάργηση της οδηγίας 2001/83/ΕΚ και της οδηγίας 2009/35/ΕΚ

  • Spanish

    Código de la Unión sobre medicamentos para uso humano y derogación de la Directiva 2001/83/CE y la Directiva 2009/35/CE

  • Estonian

    Inimtervishoius kasutatavaid ravimeid käsitlevad liidu eeskirjad ning direktiivi 2001/83/EÜ ja direktiivi 2009/35/EÜ kehtetuks tunnistamine

  • Finnish

    Ihmisille tarkoitettuja lääkkeitä koskevat unionin säännöt sekä direktiivin 2001/83/EY ja direktiivin 2009/35/EY kumoaminen

  • French

    Code de l’Union relatif aux médicaments à usage humain, et abrogation de la directive 2001/83/CE et de la directive 2009/35/CE

  • Irish

    Cód de chuid an Aontais maidir le táirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE

  • Croatian

    Zakonik Unije o lijekovima za humanu primjenu i stavljanje izvan snage Direktive 2001/83/EZ i Direktive 2009/35/EZ

  • Hungarian

    Az emberi alkalmazásra szánt gyógyszerek uniós kódexe, valamint a 2001/83/EK irányelv és a 2009/35/EK irányelv hatályon kívül helyezése

  • Italian

    Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE

  • Lithuanian

    Sąjungos kodeksas, kuriuo reglamentuojami žmonėms skirti vaistai, direktyvų 2001/83/EB ir 2009/35/EB panaikinimas

  • Latvian

    Cilvēkiem paredzētu zāļu Savienības kodekss un Direktīvas 2001/83/EK un Direktīvas 2009/35/EK atcelšana

  • Maltese

    Il-kodiċi tal-Unjoni relatat mal-prodotti mediċinali għall-użu mill-bniedem, u t-tħassir tad-Direttiva 2001/83/KE u d-Direttiva 2009/35/KE

  • Dutch

    Vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG

  • Polish

    Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE

  • Portuguese

    Código da União respeitante aos medicamentos para uso humano e revogação da Diretiva 2001/83/CE e da Diretiva 2009/35/CE

  • Romanian

    Codul Uniunii cu privire la medicamentele de uz uman și abrogarea Directivei 2001/83/CE și a Directivei 2009/35/CE

  • Slovak

    Kódex Únie týkajúci sa liekov na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES

  • Slovenian

    Zakonik Unije o zdravilih za uporabo v humani medicini ter razveljavitvi Direktive 2001/83/ES in Direktive 2009/35/ES

  • Swedish

    Unionsregler för humanläkemedel och upphävande av direktiv 2001/83/EG och direktiv 2009/35/EG

Timeline

  1. 14 September 2023

    Introduced

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

    Source: COD

  2. 14 September 2023

    referral

    Source: REFERRAL

  3. 3 October 2023

    committee tabling report

    Source: COMMITTEE_TABLING_REPORT

  4. 21 November 2023

    committee tabling amendment

    Source: COMMITTEE_TABLING_AMENDMENT

  5. 21 November 2023

    committee tabling amendment

    Source: COMMITTEE_TABLING_AMENDMENT

  6. 21 November 2023

    committee tabling amendment

    Source: COMMITTEE_TABLING_AMENDMENT

  7. 21 November 2023

    committee tabling amendment

    Source: COMMITTEE_TABLING_AMENDMENT

  8. 13 February 2024

    committee adopting opinion

    Source: COMMITTEE_ADOPTING_OPINION

  9. 22 February 2024

    committee adopting opinion

    Source: COMMITTEE_ADOPTING_OPINION

  10. 19 March 2024

    committee adopting report

    Source: COMMITTEE_ADOPTING_REPORT

  11. 21 March 2024

    tabling plenary

    Source: TABLING_PLENARY

  12. 10 April 2024

    Plenary debate

    Source: PLENARY_DEBATE

  13. 10 April 2024

    Plenary vote

    Source: PLENARY_VOTE

  14. 10 April 2024

    Vote results

    Source: PLENARY_VOTE_RESULTS

  15. 10 April 2024

    plenary amend proposal

    Source: PLENARY_AMEND_PROPOSAL

  16. 10 April 2024

    Plenary vote

    Source: PLENARY_VOTE

  17. 10 April 2024

    Plenary debate

    Source: PLENARY_DEBATE

  18. 17 June 2025

    interinstitutional negotiation

    Source: INTERINSTITUTIONAL_NEGOTIATION

  19. 7 October 2025

    interinstitutional negotiation

    Source: INTERINSTITUTIONAL_NEGOTIATION

  20. 11 November 2025

    interinstitutional negotiation

    Source: INTERINSTITUTIONAL_NEGOTIATION

  21. 10 December 2025

    interinstitutional negotiation

    Source: INTERINSTITUTIONAL_NEGOTIATION

  22. 18 March 2026

    committee approve provisional agreement

    Source: COMMITTEE_APPROVE_PROVISIONAL_AGREEMENT

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