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

votedEuropean Union· European Parliament· EN

Introduced

14 September 2023

Last action

18 March 2026 · committee approve provisional agreement

Status

PLENARY_VOTE

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

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Documents

419 official files

ÆNDRINGSFORSLAG 418 - 812 - Udkast til udtalelse EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF

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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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POZMĚŇOVACÍ NÁVRHY 1208 - 1636 - Návrh zprávy Kodex Unie týkající se humánních léčivých přípravků a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 5 December 2023
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POZMĚŇOVACÍ NÁVRHY 1208 - 1636 - Návrh zprávy Kodex Unie týkající se humánních léčivých přípravků a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 5 December 2023
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AMENDEMENTS 813 - 1207 - 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 · 5 December 2023
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AMENDEMENTS 813 - 1207 - 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 · 5 December 2023
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ÆNDRINGSFORSLAG 813 - 1207 - Udkast til betænkning om en 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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ÆNDRINGSFORSLAG 813 - 1207 - Udkast til betænkning om en 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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POZMĚŇOVACÍ NÁVRHY 418 - 812 - Návrh stanoviska Kodexu Unie týkající se humánních léčivých přípravků a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 5 December 2023
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POZMĚŇOVACÍ NÁVRHY 418 - 812 - Návrh stanoviska Kodexu Unie týkající se humánních léčivých přípravků a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 5 December 2023
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POZMĚŇOVACÍ NÁVRHY 143 - 417 - Návrh zprávy Kodex Unie týkající se humánních léčivých přípravků a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 5 December 2023
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POZMĚŇOVACÍ NÁVRHY 143 - 417 - Návrh zprávy Kodex Unie týkající se humánních léčivých přípravků a zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
AMENDMENT_LIST · CS · 5 December 2023
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ÆNDRINGSFORSLAG 1208 - 1636 - Udkast til betænkning om en 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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ÆNDRINGSFORSLAG 1208 - 1636 - Udkast til betænkning om en 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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POZMEŇUJÚCE NÁVRHY 1208 - 1636 - Návrh správy Kódex Únie o liekoch na humánne použitie a o zrušení smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 1 December 2023
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POZMEŇUJÚCE NÁVRHY 1208 - 1636 - Návrh správy Kódex Únie o liekoch na humánne použitie a o zrušení smernice 2001/83/ES a smernice 2009/35/ES
AMENDMENT_LIST · SK · 1 December 2023
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AMENDMENTS 1208 - 1636 - Draft report Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
AMENDMENT_LIST · EN · 30 November 2023
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AMENDMENTS 1208 - 1636 - Draft report Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
AMENDMENT_LIST · EN · 30 November 2023
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AMENDMENTS 143 - 417 - Draft report Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
AMENDMENT_LIST · EN · 29 November 2023
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AMENDMENTS 143 - 417 - Draft report Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
AMENDMENT_LIST · EN · 29 November 2023
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AMENDMENTS 418 - 812 - Draft opinion Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
AMENDMENT_LIST · EN · 29 November 2023
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AMENDMENTS 418 - 812 - Draft opinion Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
AMENDMENT_LIST · EN · 29 November 2023
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AMENDMENTS 813 - 1207 - Draft report Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
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AMENDMENTS 813 - 1207 - Draft report Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
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NUOMONĖS PROJEKTAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos dėl Sąjungos kodekso, kuriuo reglamentuojami žmonėms skirti vaistai, kuria panaikinamos direktyvos 2001/83/EB ir 2009/35/EB
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · LT · 23 November 2023
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NUOMONĖS PROJEKTAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos dėl Sąjungos kodekso, kuriuo reglamentuojami žmonėms skirti vaistai, kuria panaikinamos direktyvos 2001/83/EB ir 2009/35/EB
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · LT · 23 November 2023
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PROGETTO DI PARERE sulla proposta di direttiva del Parlamento europeo e del Consiglio recante un codice dell'Unione relativo ai medicinali per uso umano e che abroga le direttive 2001/83/CE e 2009/35/CE
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · IT · 23 November 2023
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PROGETTO DI PARERE sulla proposta di direttiva del Parlamento europeo e del Consiglio recante un codice dell'Unione relativo ai medicinali per uso umano e che abroga le direttive 2001/83/CE e 2009/35/CE
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · IT · 23 November 2023
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PROIECT DE AVIZ referitor la propunerea de directivă a Parlamentului European și a Consiliului de instituire a unui cod al Uniunii cu privire la medicamentele de uz uman și de abrogare a Directivei 2001/83/CE și a Directivei 2009/35/CE
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · RO · 23 November 2023
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PROIECT DE AVIZ referitor la propunerea de directivă a Parlamentului European și a Consiliului de instituire a unui cod al Uniunii cu privire la medicamentele de uz uman și de abrogare a Directivei 2001/83/CE și a Directivei 2009/35/CE
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · RO · 23 November 2023
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ENTWURF EINER STELLUNGNAHME zu dem Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · DE · 23 November 2023
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ENTWURF EINER STELLUNGNAHME zu dem Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Schaffung eines Unionskodexes für Humanarzneimittel und zur Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · DE · 23 November 2023
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ARVAMUSE PROJEKT mis käsitleb ettepanekut võtta vastu Euroopa Parlamendi ja nõukogu direktiiv inimtervishoius kasutatavaid ravimeid käsitlevate liidu eeskirjade kohta ning millega tunnistatakse kehtetuks direktiiv 2001/83/EÜ ja direktiiv 2009/35/EÜ
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · ET · 23 November 2023
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ARVAMUSE PROJEKT mis käsitleb ettepanekut võtta vastu Euroopa Parlamendi ja nõukogu direktiiv inimtervishoius kasutatavaid ravimeid käsitlevate liidu eeskirjade kohta ning millega tunnistatakse kehtetuks direktiiv 2001/83/EÜ ja direktiiv 2009/35/EÜ
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · ET · 23 November 2023
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ATZINUMA PROJEKTS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai par Savienības kodeksu, kas attiecas uz cilvēkiem paredzētām zālēm, un ar ko atceļ Direktīvu 2001/83/EK un Direktīvu 2009/35/EK
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · LV · 23 November 2023
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ATZINUMA PROJEKTS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai par Savienības kodeksu, kas attiecas uz cilvēkiem paredzētām zālēm, un ar ko atceļ Direktīvu 2001/83/EK un Direktīvu 2009/35/EK
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · LV · 23 November 2023
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UDKAST TIL UDTALELSE om forslag til Europa-Parlamentets og Rådets direktiv om en EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · DA · 23 November 2023
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UDKAST TIL UDTALELSE om forslag til Europa-Parlamentets og Rådets direktiv om en EU-kodeks for humanmedicinske lægemidler og om ophævelse af direktiv 2001/83/EF og 2009/35/EF
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · DA · 23 November 2023
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LAUSUNTOLUONNOS ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista unionin säännöistä sekä direktiivin 2001/83/EY ja direktiivin 2009/35/EY kumoamisesta
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · FI · 23 November 2023
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LAUSUNTOLUONNOS ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista unionin säännöistä sekä direktiivin 2001/83/EY ja direktiivin 2009/35/EY kumoamisesta
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · FI · 23 November 2023
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NÁVRH STANOVISKA k návrhu smernice Európskeho parlamentu a Rady o kódexe Únie o liekoch na humánne použitie a o zrušení smernice 2001/83/ES a smernice 2009/35/ES
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · SK · 23 November 2023
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NÁVRH STANOVISKA k návrhu smernice Európskeho parlamentu a Rady o kódexe Únie o liekoch na humánne použitie a o zrušení smernice 2001/83/ES a smernice 2009/35/ES
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · SK · 23 November 2023
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PROJEKT OPINII w sprawie wniosku dotyczącego 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
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · PL · 23 November 2023
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PROJEKT OPINII w sprawie wniosku dotyczącego 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
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · PL · 23 November 2023
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NÁVRH STANOVISKA k návrhu směrnice Evropského parlamentu a Rady o kodexu Unie týkajícím se humánních léčivých přípravků a o zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · CS · 23 November 2023
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NÁVRH STANOVISKA k návrhu směrnice Evropského parlamentu a Rady o kodexu Unie týkajícím se humánních léčivých přípravků a o zrušení směrnice 2001/83/ES a směrnice 2009/35/ES
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · CS · 23 November 2023
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ПРОЕКТ НА СТАНОВИЩЕ относно предложението 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
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · BG · 23 November 2023
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ПРОЕКТ НА СТАНОВИЩЕ относно предложението 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
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · BG · 23 November 2023
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FÖRSLAG TILL YTTRANDE över förslaget till Europaparlamentets och rådets direktiv om unionsregler för humanläkemedel och om upphävande av direktiv 2001/83/EG och direktiv 2009/35/EG
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · SV · 23 November 2023
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FÖRSLAG TILL YTTRANDE över förslaget till Europaparlamentets och rådets direktiv om unionsregler för humanläkemedel och om upphävande av direktiv 2001/83/EG och direktiv 2009/35/EG
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · SV · 23 November 2023
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VÉLEMÉNYTERVEZET az emberi alkalmazásra szánt gyógyszerek uniós kódexéről, valamint a 2001/83/EK irányelv és a 2009/35/EK irányelv hatályon kívül helyezéséről szóló európai parlamenti és tanácsi irányelvre irányuló javaslatról
OPINION_PARLIAMENTARY_COMMITTEE_DRAFT · HU · 22 November 2023
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2023%2F0132(COD)
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eu · 2023-0132 · source updated 18 March 2026