European Union · 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
Introduced
14 September 2023
Last action
18 March 2026 · committee approve provisional agreement
Status
PLENARY_VOTE
Sponsors
—
Subjects
Discovery layer
Source updated
18 March 2026
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
Records
Official bill 2023/0132(COD) from European Union at European Parliament. Dated 14 September 2023. Status: PLENARY_VOTE.
Timeline
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
14 September 2023
referral
Source: REFERRAL
3 October 2023
committee tabling report
Source: COMMITTEE_TABLING_REPORT
21 November 2023
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
21 November 2023
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
21 November 2023
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
21 November 2023
committee tabling amendment
Source: COMMITTEE_TABLING_AMENDMENT
13 February 2024
committee adopting opinion
Source: COMMITTEE_ADOPTING_OPINION
22 February 2024
committee adopting opinion
Source: COMMITTEE_ADOPTING_OPINION
19 March 2024
committee adopting report
Source: COMMITTEE_ADOPTING_REPORT
21 March 2024
tabling plenary
Source: TABLING_PLENARY
10 April 2024
Plenary debate
Source: PLENARY_DEBATE
10 April 2024
Plenary vote
Source: PLENARY_VOTE
10 April 2024
Vote results
Source: PLENARY_VOTE_RESULTS
10 April 2024
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
10 April 2024
Plenary vote
Source: PLENARY_VOTE
10 April 2024
Plenary debate
Source: PLENARY_DEBATE
17 June 2025
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
7 October 2025
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
11 November 2025
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
10 December 2025
interinstitutional negotiation
Source: INTERINSTITUTIONAL_NEGOTIATION
18 March 2026
committee approve provisional agreement
Source: COMMITTEE_APPROVE_PROVISIONAL_AGREEMENT
Votes
No vote records are attached yet.
Versions
No version snapshots stored. Document URLs remain at the source.
Documents
419 official files
AMENDAMENTELE 813 - 1207 - Proiect de raport Codul Uniunii cu privire la medicamentele de uz uman și abrogarea Directivei 2001/83/CE și a Directivei 2009/35/CE
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AMENDAMENTELE 813 - 1207 - Proiect de raport Codul Uniunii cu privire la medicamentele de uz uman și abrogarea Directivei 2001/83/CE și a Directivei 2009/35/CE
AMENDMENT_LIST · RO · 3 January 2024
EMENDI 813 - 1207 - Abbozz ta’ rapport 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
AMENDMENT_LIST · MT · 3 January 2024
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EMENDI 813 - 1207 - Abbozz ta’ rapport 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
AMENDMENT_LIST · MT · 3 January 2024
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AMENDEMENTEN 143 - 417 - Ontwerpverslag Vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG
AMENDMENT_LIST · NL · 3 January 2024
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AMENDEMENTEN 143 - 417 - Ontwerpverslag Vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG
AMENDMENT_LIST · NL · 3 January 2024
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AMENDEMENTEN 418 - 812 - Ontwerpadvies Vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG
AMENDMENT_LIST · NL · 3 January 2024
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AMENDEMENTEN 418 - 812 - Ontwerpadvies Vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG
AMENDMENT_LIST · NL · 3 January 2024
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ИЗМЕНЕНИЯ 418 – 812 - Проект на становище Предложение за директива на Европейския парламент и на Съвета относно Кодекса на Съюза за лекарствените продукти за хуманна употреба и за отмяна на Директива 2001/83/ЕО и Директива 2009/35/ЕО
AMENDMENT_LIST · BG · 21 December 2023
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ИЗМЕНЕНИЯ 418 – 812 - Проект на становище Предложение за директива на Европейския парламент и на Съвета относно Кодекса на Съюза за лекарствените продукти за хуманна употреба и за отмяна на Директива 2001/83/ЕО и Директива 2009/35/ЕО
AMENDMENT_LIST · BG · 21 December 2023
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ÄNDERUNGSANTRÄGE 418 - 812 - Entwurf einer Stellungnahme zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 21 December 2023
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ÄNDERUNGSANTRÄGE 418 - 812 - Entwurf einer Stellungnahme zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 21 December 2023
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ÄNDERUNGSANTRÄGE 143 - 417 - Entwurf eines Berichts zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 20 December 2023
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ÄNDERUNGSANTRÄGE 143 - 417 - Entwurf eines Berichts zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 20 December 2023
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ÄNDERUNGSANTRÄGE 1208 - 1636 - Entwurf eines Berichts zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 20 December 2023
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ÄNDERUNGSANTRÄGE 1208 - 1636 - Entwurf eines Berichts zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 20 December 2023
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ÄNDERUNGSANTRÄGE 813 - 1207 - Entwurf eines Berichts Unionskodex für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 19 December 2023
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ÄNDERUNGSANTRÄGE 813 - 1207 - Entwurf eines Berichts Unionskodex für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
AMENDMENT_LIST · DE · 19 December 2023
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POPRAWKI 143 - 417 - Projekt sprawozdania Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POPRAWKI 143 - 417 - Projekt sprawozdania Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POPRAWKI 1208 - 1636 - Projekt sprawozdania Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POPRAWKI 1208 - 1636 - Projekt sprawozdania Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POZMEŇUJÚCE NÁVRHY 143 - 417 - Návrh správy Kódex Únie o liekoch na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 6 December 2023
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POZMEŇUJÚCE NÁVRHY 143 - 417 - Návrh správy Kódex Únie o liekoch na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 6 December 2023
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POPRAWKI 418 - 812 - Projekt opinii Wniosek dotyczący dyrektywy Parlamentu Europejskiego i Rady w sprawie unijnego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi oraz uchylającej dyrektywę 2001/83/WE i dyrektywę 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POPRAWKI 418 - 812 - Projekt opinii Wniosek dotyczący dyrektywy Parlamentu Europejskiego i Rady w sprawie unijnego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi oraz uchylającej dyrektywę 2001/83/WE i dyrektywę 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POPRAWKI 813 - 1207 - Projekt sprawozdania Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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POPRAWKI 813 - 1207 - Projekt sprawozdania Unijny kodeks odnoszący się do produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/83/WE i dyrektywy 2009/35/WE
AMENDMENT_LIST · PL · 6 December 2023
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ÆNDRINGSFORSLAG 143 - 417 - Udkast til betænkning EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF
AMENDMENT_LIST · DA · 6 December 2023
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ÆNDRINGSFORSLAG 143 - 417 - Udkast til betænkning EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF
AMENDMENT_LIST · DA · 6 December 2023
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POZMEŇUJÚCE NÁVRHY 813 - 1207 - Návrh správy Kódex Únie o liekoch na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 6 December 2023
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POZMEŇUJÚCE NÁVRHY 813 - 1207 - Návrh správy Kódex Únie o liekoch na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 6 December 2023
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EMENDAMENTI 143 - 417 - Progetto di relazione Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 6 December 2023
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EMENDAMENTI 143 - 417 - Progetto di relazione Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 6 December 2023
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POZMEŇUJÚCE NÁVRHY 418 - 812 - Návrh stanoviska Kódex Únie o liekoch na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 6 December 2023
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POZMEŇUJÚCE NÁVRHY 418 - 812 - Návrh stanoviska Kódex Únie o liekoch na humánne použitie a zrušenie smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 6 December 2023
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AMENDEMENTS 418 - 812 - Projet d’avis instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE
AMENDMENT_LIST · FR · 6 December 2023
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AMENDEMENTS 418 - 812 - Projet d’avis instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE
AMENDMENT_LIST · FR · 6 December 2023
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POZMĚŇOVACÍ NÁVRHY 813 - 1207 - Návrh zprávy o kodexu Unie týkajícím se humánních léčivých přípravků a o zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 6 December 2023
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POZMĚŇOVACÍ NÁVRHY 813 - 1207 - Návrh zprávy o kodexu Unie týkajícím se humánních léčivých přípravků a o zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 6 December 2023
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AMENDEMENTS 1208 - 1636 - Projet de rapport instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE
AMENDMENT_LIST · FR · 6 December 2023
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AMENDEMENTS 1208 - 1636 - Projet de rapport instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE
AMENDMENT_LIST · FR · 6 December 2023
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AMENDEMENTS 143 - 417 - Projet de rapport Établissement d’un 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
AMENDMENT_LIST · FR · 5 December 2023
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AMENDEMENTS 143 - 417 - Projet de rapport Établissement d’un 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
AMENDMENT_LIST · FR · 5 December 2023
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EMENDAMENTI 813 - 1207 - Progetto di relazione Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 5 December 2023
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EMENDAMENTI 813 - 1207 - Progetto di relazione Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 5 December 2023
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EMENDAMENTI 418 - 812 - Progetto di parere Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 5 December 2023
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EMENDAMENTI 418 - 812 - Progetto di parere Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 5 December 2023
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EMENDAMENTI 1208 - 1636 - Progetto di relazione Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 5 December 2023
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EMENDAMENTI 1208 - 1636 - Progetto di relazione Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE
AMENDMENT_LIST · IT · 5 December 2023
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ÆNDRINGSFORSLAG 418 - 812 - Udkast til udtalelse EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF
AMENDMENT_LIST · DA · 5 December 2023
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- Kateřina KONEČNÁ · The Left · RAPPORTEUR_SHADOW
- · JURI · COMMITTEE_OPINION_ASSOCIATED
- Dolors MONTSERRAT · PPE · RAPPORTEUR
- Pernille WEISS-EHLER · PPE · RAPPORTEUR
- Vlad VASILE-VOICULESCU · Renew · RAPPORTEUR_SHADOW
- Adrián VÁZQUEZ LÁZARA · Renew · RAPPORTEUR_OPINION
- Joanna KOPCIŃSKA · ECR · RAPPORTEUR_SHADOW
- Susana SOLÍS PÉREZ · Renew · RAPPORTEUR_SHADOW_OPINION
- Nicolás GONZÁLEZ CASARES · S&D · RAPPORTEUR_SHADOW
- Tilly METZ · Verts/ALE · RAPPORTEUR_SHADOW
- Monika BEŇOVÁ · S&D · RAPPORTEUR_SHADOW
- Annalisa TARDINO · ID · RAPPORTEUR_SHADOW
- Nicolás GONZÁLEZ CASARES · S&D · RAPPORTEUR_SHADOW_OPINION
- Henna VIRKKUNEN · PPE · RAPPORTEUR_OPINION
- Catherine AMALRIC · Renew · RAPPORTEUR_SHADOW
- · SANT · COMMITTEE_LEAD
- Margarita DE LA PISA CARRIÓN · PfE · RAPPORTEUR_SHADOW
- Kristoffer STORM · ECR · RAPPORTEUR_SHADOW
- Ville NIINISTÖ · Verts/ALE · RAPPORTEUR_SHADOW_OPINION
- · IMCO · COMMITTEE_OPINION
- Margrete AUKEN · Verts/ALE · RAPPORTEUR_SHADOW
- Christine ANDERSON · ESN · RAPPORTEUR_SHADOW
- · BUDG · COMMITTEE_OPINION
- Margarita DE LA PISA CARRIÓN · ECR · RAPPORTEUR_SHADOW_OPINION
- Giorgos GEORGIOU · The Left · RAPPORTEUR_SHADOW
- · ENVI · COMMITTEE_LEAD
- · ITRE · COMMITTEE_OPINION
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Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2023%2F0132(COD)
- Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2023-0132
- eu · 2023-0132 · source updated 18 March 2026