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

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
Установяване на процедури на Съюза за разрешаване и надзор на лекарствени продукти за хуманна употреба и на правила за работата на Европейската агенция по лекарствата, изменение на Регламент (ЕО) № 1394/2007 и Регламент (ЕС) № 536/2014 и отмяна на Регламент (ЕО) № 726/2004, Регламент (ЕО) № 141/2000 и Регламент (ЕО) № 1901/2006
Czech
Stanovení postupu Unie pro registraci humánních léčivých přípravků a dozor nad nimi, stanovení pravidel, kterými se řídí Evropská agentura pro léčivé přípravky, změna nařízení (ES) č. 1394/2007 a nařízení (EU) č. 536/2014 a zrušení nařízení (ES) č. 726/2004, nařízení (ES) č. 141/2000 a nařízení (ES) č. 1901/2006
Danish
Fastlæggelse af EU-procedurer for godkendelse og overvågning af humanmedicinske lægemidler og fastsættelse af regler for Det Europæiske Lægemiddelagentur, ændring af forordning (EF) nr. 1394/2007 og (EU) nr. 536/2014 og ophævelse af forordning (EF) nr. 726/2004, (EF) nr. 141/2000 og (EF) nr. 1901/2006
German
Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und Festlegung von Vorschriften für die Europäische Arzneimittel-Agentur, Änderung der Verordnung (EG) Nr. 1394/2007 und der Verordnung (EU) Nr. 536/2014 sowie Aufhebung der Verordnung (EG) Nr. 726/2004, der Verordnung (EG) Nr. 141/2000 und der Verordnung (EG) Nr. 1901/2006
Greek
Καθορισμός ενωσιακών διαδικασιών για τη χορήγηση άδειας και παρακολούθηση των φαρμάκων για ανθρώπινη χρήση και θέσπιση κανόνων που διέπουν τον Ευρωπαϊκό Οργανισμό Φαρμάκων, τροποποίηση του κανονισμού (ΕΚ) αριθ. 1394/2007 και του κανονισμού (ΕΕ) αριθ. 536/2014 και κατάργηση του κανονισμού (ΕΚ) αριθ. 726/2004, του κανονισμού (ΕΚ) αριθ. 141/2000 του κανονισμού (ΕΚ) αριθ. 1901/2006
Spanish
Establecimiento de los procedimientos de la Unión para la autorización y el control de los medicamentos de uso humano, establecimiento de las normas por las que se rige la Agencia Europea de Medicamentos, modificación del Reglamento (CE) n.º 1394/2007 y el Reglamento (UE) n.º 536/2014 y derogación del Reglamento (CE) n.º 726/2004, el Reglamento (CE) n.º 141/2000 y el Reglamento (CE) n.º 1901/2006
Estonian
Liidu korra sätestamine inimtervishoius kasutatavate ravimite müügilubade andmise ja järelevalve kohta ning Euroopa Ravimiametit reguleerivate eeskirjade kehtestamine, määruse (EÜ) nr 1394/2007 ja määruse (EL) nr 536/2014 muutmine ning määruse (EÜ) nr 726/2004, määruse (EÜ) nr 141/2000 ja määruse (EÜ) nr 1901/2006 kehtetuks tunnistamine
Finnish
Ihmisille tarkoitettuja lääkkeitä koskevat unionin lupa- ja valvontamenettelyt ja Euroopan lääkevirastoa koskevat säännöt, asetuksen (EY) N:o 1394/2007 ja asetuksen (EU) N:o 536/2014 muuttaminen sekä asetuksen (EY) N:o 726/2004, asetuksen (EY) N:o 141/2000 ja asetuksen (EY) N:o 1901/2006 kumoaminen
French
Établissement de procédures de l’Union pour l’autorisation et la surveillance des médicaments à usage humain et établissement de règles régissant l’Agence européenne des médicaments, modification du règlement (CE) nº 1394/2007 et du règlement (UE) nº 536/2014, et abrogation du règlement (CE) nº 726/2004, du règlement (CE) nº 141/2000 et du règlement (CE) nº 1901/2006
Irish
Nósanna imeachta de chuid an Aontais a leagan síos maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006
Croatian
Utvrđivanje postupaka Unije za odobravanje i nadzor lijekova za humanu primjenu i utvrđivanje pravila o Europskoj agenciji za lijekove te izmjena Uredbe (EZ) br. 1394/2007 i Uredbe (EU) br. 536/2014 i stavljanje izvan snage Uredbe (EZ) br. 726/2004, Uredbe (EZ) br. 141/2000 i Uredbe (EZ) br. 1901/2006
Hungarian
Az emberi alkalmazásra szánt gyógyszerek uniós szintű engedélyezésére és felügyeletére vonatkozó uniós eljárások meghatározása és az Európai Gyógyszerügynökségre irányadó szabályok megállapítása, az 1394/2007/EK rendelet és az 536/2014/EU rendelet módosítása, valamint a 726/2004/EK rendelet, a 141/2000/EK rendelet és az 1901/2006/EK rendelet hatályon kívül helyezése
Italian
Istituzione delle procedure dell'Unione per l'autorizzazione e la sorveglianza dei medicinali per uso umano, definizione delle norme che disciplinano l'Agenzia europea per i medicinali, modifica dei regolamenti (CE) n. 1394/2007 e (UE) n. 536/2014 e abrogazione dei regolamenti (CE) n. 726/2004, (CE) n. 141/2000 e (CE) n. 1901/2006
Lithuanian
Sąjungos žmonėms skirtų vaistų rinkodaros leidimų suteikimo ir priežiūros procedūrų ir taisyklių, kuriomis reglamentuojama Europos vaistų agentūros veikla, nustatymas, Reglamento (EB) Nr. 1394/2007 ir Reglamento (ES) Nr. 536/2014 dalinis keitimas ir Reglamento (EB) Nr. 726/2004, Reglamento (EB) Nr. 141/2000 ir Reglamento (EB) Nr. 1901/2006 panaikinimas
Latvian
Savienības procedūru noteikšana attiecībā uz cilvēkiem paredzētu zāļu apstiprināšanu un uzraudzību un Eiropas Zāļu aģentūras reglamentēšanas noteikumu izveide, Regulas (EK) Nr. 1394/2007 un Regulas (ES) Nr. 536/2014 grozīšana un Regulas (EK) Nr. 726/2004, Regulas (EK) Nr.141/2000 un Regulas (EK) Nr.1901/2006 atcelšana
Maltese
L-istabbiliment ta' proċeduri tal-Unjoni għall-awtorizzazzjoni u għas-superviżjoni ta' prodotti mediċinali għall-użu mill-bniedem u l-istabbiliment tar-regoli li jirregolaw l-Aġenzija Ewropea għall-Mediċini, l-emenda tar-Regolament (KE) Nru 1394/2007 u r-Regolament (UE) Nru 536/2014 u t-tħassir tar-Regolament (KE) Nru 726/2004, ir-Regolament (KE) Nru 141/2000 u r-Regolament (KE) Nru 1901/2006
Dutch
Vaststelling van procedures van de Unie voor het verlenen van vergunningen en het toezicht met betrekking tot geneesmiddelen voor menselijk gebruik en vaststelling van regels voor het Europees Geneesmiddelenbureau, wijziging van Verordening (EG) nr. 1394/2007 en Verordening (EU) nr. 536/2014 en intrekking van Verordening (EG) nr. 726/2004, Verordening (EG) nr. 141/2000 en Verordening (EG) nr. 1901/2006
Polish
Ustanowienie unijnej procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i nadzoru nad nimi oraz ustanowienie Europejskiej Agencji Leków, zmiana rozporządzenia (WE) nr 1394/2007 i rozporządzenia (UE) nr 536/2014 oraz uchylenie rozporządzenia (WE) nr 726/2004, rozporządzenia (WE) nr 141/2000 i rozporządzenia (WE) nr 1901/2006
Portuguese
Estabelecimento de procedimentos da União para a autorização e a supervisão de medicamentos para uso humano e estabelecimento de regras que regem a Agência Europeia de Medicamentos, alteração do Regulamento (CE) n.º 1394/2007 e do Regulamento (UE) n.º 536/2014 e revogação do Regulamento (CE) n.º 726/2004, do Regulamento (CE) n.º 141/2000 e do Regulamento (CE) n.º 1901/2006
Romanian
Stabilirea procedurilor la nivelul Uniunii privind autorizarea și supravegherea medicamentelor de uz uman și stabilirea normelor care reglementează Agenția Europeană pentru Medicamente, modificarea Regulamentului (CE) nr. 1394/2007 și a Regulamentului (UE) nr. 536/2014 și abrogarea Regulamentului (CE) nr. 726/2004, a Regulamentului (CE) nr. 141/2000 și a Regulamentului (CE) nr. 1901/2006
Slovak
Stanovenie postupov Únie na povoľovanie a dohľad nad liekmi na humánne použitie a pravidiel, ktorými sa riadi Európska agentúra pre lieky, zmena a doplnenie nariadenia (ES) č. 1394/2007 a nariadenia (EÚ) č. 536/2014 a zrušenie nariadenia (ES) č. 726/2004, nariadenia (ES) č. 141/2000 a nariadenia (ES) č. 1901/2006
Slovenian
Postopki Unije za odobritev in nadzor zdravil za uporabo v humani medicini ter določitev pravil, ki urejajo Evropsko agencijo za zdravila, spremembi uredb (ES) št. 1394/2007 in (EU) št. 536/2014 ter razveljavitvi uredb (ES) št. 726/2004, (ES) št. 141/2000 in (ES) št. 1901/2006
Swedish
Inrättande av unionsförfaranden för godkännande av och tillsyn över humanläkemedel och fastställande av regler för Europeiska läkemedelsmyndigheten samt ändring av förordning (EG) nr 1394/2007 och förordning (EU) nr 536/2014 och upphävande av förordning (EG) nr 726/2004, förordning (EG) nr 141/2000 och förordning (EG) nr 1901/2006

Records

Official bill 2023/0131(COD) from European Union at European Parliament. Dated 14 September 2023. Status: PLENARY_VOTE.

Timeline

14 September 2023
Introduced
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
Source: COD
14 September 2023
referral
Source: REFERRAL
20 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
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
24 January 2024
committee adopting opinion
Source: COMMITTEE_ADOPTING_OPINION
14 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 amend proposal
Source: PLENARY_AMEND_PROPOSAL
10 April 2024
Vote results
Source: PLENARY_VOTE_RESULTS
10 April 2024
Plenary vote
Source: PLENARY_VOTE
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

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Documents

731 official files

SPRAWOZDANIE 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

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SPRAWOZDANIE 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
REPORT_PLENARY · PL · 8 April 2024
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IZVJEŠĆE o Prijedlogu uredbe Europskog parlamenta i Vijeća o utvrđivanju postupaka Unije za odobravanje i nadzor lijekova za humanu primjenu, o utvrđivanju pravila o Europskoj agenciji za lijekove te o izmjeni Uredbe (EZ) br. 1394/2007 i Uredbe (EU) br. 536/2014 i stavljanju izvan snage Uredbe (EZ) br. 726/2004, Uredbe (EZ) br. 141/2000 i Uredbe (EZ) br. 1901/2006
REPORT_PLENARY · HR · 8 April 2024
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IZVJEŠĆE o Prijedlogu uredbe Europskog parlamenta i Vijeća o utvrđivanju postupaka Unije za odobravanje i nadzor lijekova za humanu primjenu, o utvrđivanju pravila o Europskoj agenciji za lijekove te o izmjeni Uredbe (EZ) br. 1394/2007 i Uredbe (EU) br. 536/2014 i stavljanju izvan snage Uredbe (EZ) br. 726/2004, Uredbe (EZ) br. 141/2000 i Uredbe (EZ) br. 1901/2006
REPORT_PLENARY · HR · 8 April 2024
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady ustanawiającego unijne procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i nadzoru nad nimi oraz ustanawiającego zasady regulujące działalność Europejskiej Agencji Leków, zmieniającego rozporządzenie (WE) nr 1394/2007 i rozporządzenie (UE) nr 536/2014 oraz uchylającego rozporządzenie (WE) nr 726/2004, rozporządzenie (WE) nr 141/2000 i rozporządzenie (WE) nr 1901/2006
REPORT_PLENARY · PL · 8 April 2024
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady ustanawiającego unijne procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i nadzoru nad nimi oraz ustanawiającego zasady regulujące działalność Europejskiej Agencji Leków, zmieniającego rozporządzenie (WE) nr 1394/2007 i rozporządzenie (UE) nr 536/2014 oraz uchylającego rozporządzenie (WE) nr 726/2004, rozporządzenie (WE) nr 141/2000 i rozporządzenie (WE) nr 1901/2006
REPORT_PLENARY · PL · 8 April 2024
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RAPORT ettepaneku kohta võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles sätestatakse liidu kord inimtervishoius kasutatavate ravimite müügilubade andmise ja järelevalve kohta ning millega kehtestatakse Euroopa Ravimiametit reguleerivad eeskirjad ning muudetakse määrust (EÜ) nr 1394/2007 ja määrust (EL) nr 536/2014 ning tunnistatakse kehtetuks määrus (EÜ) nr 726/2004, määrus (EÜ) nr 141/2000 ja määrus (EÜ) nr 1901/2006
REPORT_PLENARY · ET · 8 April 2024
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RAPORT ettepaneku kohta võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles sätestatakse liidu kord inimtervishoius kasutatavate ravimite müügilubade andmise ja järelevalve kohta ning millega kehtestatakse Euroopa Ravimiametit reguleerivad eeskirjad ning muudetakse määrust (EÜ) nr 1394/2007 ja määrust (EL) nr 536/2014 ning tunnistatakse kehtetuks määrus (EÜ) nr 726/2004, määrus (EÜ) nr 141/2000 ja määrus (EÜ) nr 1901/2006
REPORT_PLENARY · ET · 8 April 2024
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista unionin säännöistä sekä direktiivin 2001/83/EY ja direktiivin 2009/35/EY kumoamisesta
REPORT_PLENARY · FI · 8 April 2024
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista unionin säännöistä sekä direktiivin 2001/83/EY ja direktiivin 2009/35/EY kumoamisesta
REPORT_PLENARY · FI · 8 April 2024
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RELAZIONE 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
REPORT_PLENARY · IT · 8 April 2024
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RELAZIONE 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
REPORT_PLENARY · IT · 8 April 2024
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ZIŅOJUMS 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
REPORT_PLENARY · LV · 8 April 2024
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ZIŅOJUMS 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
REPORT_PLENARY · LV · 8 April 2024
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RAPORT ettepaneku kohta 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
REPORT_PLENARY · ET · 8 April 2024
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RAPORT ettepaneku kohta 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
REPORT_PLENARY · ET · 8 April 2024
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil établissant des procédures de l’Union pour l’autorisation et la surveillance des médicaments à usage humain et établissant des règles régissant l’Agence européenne des médicaments, modifiant le règlement (CE) nº 1394/2007 et le règlement (UE) nº 536/2014 et abrogeant le règlement (CE) nº 726/2004, le règlement (CE) nº 141/2000 et le règlement (CE) nº 1901/2006
REPORT_PLENARY · FR · 8 April 2024
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil établissant des procédures de l’Union pour l’autorisation et la surveillance des médicaments à usage humain et établissant des règles régissant l’Agence européenne des médicaments, modifiant le règlement (CE) nº 1394/2007 et le règlement (UE) nº 536/2014 et abrogeant le règlement (CE) nº 726/2004, le règlement (CE) nº 141/2000 et le règlement (CE) nº 1901/2006
REPORT_PLENARY · FR · 8 April 2024
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INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo por la que se establece un código de la Unión sobre medicamentos para uso humano y por la que se derogan la Directiva 2001/83/CE y la Directiva 2009/35/CE
REPORT_PLENARY · ES · 8 April 2024
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INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo por la que se establece un código de la Unión sobre medicamentos para uso humano y por la que se derogan la Directiva 2001/83/CE y la Directiva 2009/35/CE
REPORT_PLENARY · ES · 8 April 2024
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RELATÓRIO sobre a proposta de diretiva do Parlamento Europeu e do Conselho que estabelece um código da União relativo aos medicamentos para uso humano e que revoga a Diretiva 2001/83/CE e a Diretiva 2009/35/CE
REPORT_PLENARY · PT · 8 April 2024
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RELATÓRIO sobre a proposta de diretiva do Parlamento Europeu e do Conselho que estabelece um código da União relativo aos medicamentos para uso humano e que revoga a Diretiva 2001/83/CE e a Diretiva 2009/35/CE
REPORT_PLENARY · PT · 8 April 2024
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VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad tot vaststelling van procedures van de Unie voor het verlenen van vergunningen en het toezicht met betrekking tot geneesmiddelen voor menselijk gebruik en tot vaststelling van regels voor het Europees Geneesmiddelenbureau, tot wijziging van Verordening (EG) nr. 1394/2007 en Verordening (EU) nr. 536/2014 en tot intrekking van Verordening (EG) nr. 726/2004, Verordening (EG) nr. 141/2000 en Verordening (EG) nr. 1901/2006
REPORT_PLENARY · NL · 8 April 2024
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VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad tot vaststelling van procedures van de Unie voor het verlenen van vergunningen en het toezicht met betrekking tot geneesmiddelen voor menselijk gebruik en tot vaststelling van regels voor het Europees Geneesmiddelenbureau, tot wijziging van Verordening (EG) nr. 1394/2007 en Verordening (EU) nr. 536/2014 en tot intrekking van Verordening (EG) nr. 726/2004, Verordening (EG) nr. 141/2000 en Verordening (EG) nr. 1901/2006
REPORT_PLENARY · NL · 8 April 2024
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes regulai, ar ko nosaka Savienības procedūras cilvēkiem paredzēto zāļu atļauju piešķiršanai un uzraudzībai un ar ko paredz noteikumus, kuri reglamentē Eiropas Zāļu aģentūras darbību, groza Regulu (EK) Nr. 1394/2007 un Regulu (ES) Nr. 536/2014 un atceļ Regulu (EK) Nr. 726/2004, Regulu (EK) Nr. 141/2000 un Regulu (EK) Nr. 1901/2006
REPORT_PLENARY · LV · 8 April 2024
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes regulai, ar ko nosaka Savienības procedūras cilvēkiem paredzēto zāļu atļauju piešķiršanai un uzraudzībai un ar ko paredz noteikumus, kuri reglamentē Eiropas Zāļu aģentūras darbību, groza Regulu (EK) Nr. 1394/2007 un Regulu (ES) Nr. 536/2014 un atceļ Regulu (EK) Nr. 726/2004, Regulu (EK) Nr. 141/2000 un Regulu (EK) Nr. 1901/2006
REPORT_PLENARY · LV · 8 April 2024
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill dwar il-kodiċi tal-Unjoni relatat mal-prodotti mediċinali għall-użu mill-bniedem, u li tħassar id-Direttiva 2001/83/KE u d-Direttiva 2009/35/KE
REPORT_PLENARY · MT · 8 April 2024
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill dwar il-kodiċi tal-Unjoni relatat mal-prodotti mediċinali għall-użu mill-bniedem, u li tħassar id-Direttiva 2001/83/KE u d-Direttiva 2009/35/KE
REPORT_PLENARY · MT · 8 April 2024
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi ihmisille tarkoitettuja lääkkeitä koskevista unionin lupa- ja valvontamenettelyistä ja Euroopan lääkevirastoa koskevista säännöistä, asetuksen (EY) N:o 1394/2007 ja asetuksen (EU) N:o 536/2014 muuttamisesta sekä asetuksen (EY) N:o 726/2004, asetuksen (EY) N:o 141/2000 ja asetuksen (EY) N:o 1901/2006 kumoamisesta
REPORT_PLENARY · FI · 8 April 2024
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi ihmisille tarkoitettuja lääkkeitä koskevista unionin lupa- ja valvontamenettelyistä ja Euroopan lääkevirastoa koskevista säännöistä, asetuksen (EY) N:o 1394/2007 ja asetuksen (EU) N:o 536/2014 muuttamisesta sekä asetuksen (EY) N:o 726/2004, asetuksen (EY) N:o 141/2000 ja asetuksen (EY) N:o 1901/2006 kumoamisesta
REPORT_PLENARY · FI · 8 April 2024
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ΕΚΘΕΣΗ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τη θέσπιση ενωσιακών διαδικασιών αδειοδότησης και εποπτείας των φαρμάκων για ανθρώπινη χρήση και τον καθορισμό κανόνων που διέπουν τον Ευρωπαϊκό Οργανισμό Φαρμάκων, για την τροποποίηση του κανονισμού (ΕΚ) αριθ. 1394/2007 και του κανονισμού (ΕΕ) αριθ. 536/2014 και για την κατάργηση του κανονισμού (ΕΚ) αριθ. 726/2004, του κανονισμού (ΕΚ) αριθ. 141/2000 και του κανονισμού (ΕΚ) αριθ. 1901/2006
REPORT_PLENARY · EL · 8 April 2024
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ΕΚΘΕΣΗ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τη θέσπιση ενωσιακών διαδικασιών αδειοδότησης και εποπτείας των φαρμάκων για ανθρώπινη χρήση και τον καθορισμό κανόνων που διέπουν τον Ευρωπαϊκό Οργανισμό Φαρμάκων, για την τροποποίηση του κανονισμού (ΕΚ) αριθ. 1394/2007 και του κανονισμού (ΕΕ) αριθ. 536/2014 και για την κατάργηση του κανονισμού (ΕΚ) αριθ. 726/2004, του κανονισμού (ΕΚ) αριθ. 141/2000 και του κανονισμού (ΕΚ) αριθ. 1901/2006
REPORT_PLENARY · EL · 8 April 2024
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POROČILO o predlogu direktive Evropskega parlamenta in Sveta o zakoniku Unije o zdravilih za uporabo v humani medicini ter razveljavitvi Direktive 2001/83/ES in Direktive 2009/35/ES
REPORT_PLENARY · SL · 8 April 2024
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POROČILO o predlogu direktive Evropskega parlamenta in Sveta o zakoniku Unije o zdravilih za uporabo v humani medicini ter razveljavitvi Direktive 2001/83/ES in Direktive 2009/35/ES
REPORT_PLENARY · SL · 8 April 2024
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου περί ενωσιακού κώδικα για τα φάρμακα που προορίζονται για ανθρώπινη χρήση, και για την κατάργηση της οδηγίας 2001/83/ΕΚ και της οδηγίας 2009/35/ΕΚ
REPORT_PLENARY · EL · 8 April 2024
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου περί ενωσιακού κώδικα για τα φάρμακα που προορίζονται για ανθρώπινη χρήση, και για την κατάργηση της οδηγίας 2001/83/ΕΚ και της οδηγίας 2009/35/ΕΚ
REPORT_PLENARY · EL · 8 April 2024
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RAPPORT sur la proposition de directive du Parlement européen et du Conseil 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
REPORT_PLENARY · FR · 8 April 2024
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RAPPORT sur la proposition de directive du Parlement européen et du Conseil 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
REPORT_PLENARY · FR · 8 April 2024
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VERSLAG over het voorstel voor een richtlijn van het Europees Parlement en de Raad tot vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en tot intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG
REPORT_PLENARY · NL · 7 April 2024
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VERSLAG over het voorstel voor een richtlijn van het Europees Parlement en de Raad tot vaststelling van een code van de Unie betreffende geneesmiddelen voor menselijk gebruik en tot intrekking van Richtlijn 2001/83/EG en Richtlijn 2009/35/EG
REPORT_PLENARY · NL · 7 April 2024
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho que estabelece procedimentos da União para a autorização e a supervisão de medicamentos para uso humano e que estabelece regras que regem a Agência Europeia de Medicamentos, que altera o Regulamento (CE) n.º 1394/2007 e o Regulamento (UE) n.º 536/2014 e que revoga o Regulamento (CE) n.º 726/2004, o Regulamento (CE) n.º 141/2000 e o Regulamento (CE) n.º 1901/2006
REPORT_PLENARY · PT · 5 April 2024
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho que estabelece procedimentos da União para a autorização e a supervisão de medicamentos para uso humano e que estabelece regras que regem a Agência Europeia de Medicamentos, que altera o Regulamento (CE) n.º 1394/2007 e o Regulamento (UE) n.º 536/2014 e que revoga o Regulamento (CE) n.º 726/2004, o Regulamento (CE) n.º 141/2000 e o Regulamento (CE) n.º 1901/2006
REPORT_PLENARY · PT · 5 April 2024
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JELENTÉS az emberi alkalmazásra szánt gyógyszerek uniós szintű engedélyezésére és felügyeletére vonatkozó uniós eljárások meghatározásáról és az Európai Gyógyszerügynökségre irányadó szabályok megállapításáról, az 1394/2007/EK rendelet és az 536/2014/EU rendelet módosításáról, valamint a 726/2004/EK rendelet, a 141/2000/EK rendelet és az 1901/2006/EK rendelet hatályon kívül helyezéséről szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról
REPORT_PLENARY · HU · 4 April 2024
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JELENTÉS az emberi alkalmazásra szánt gyógyszerek uniós szintű engedélyezésére és felügyeletére vonatkozó uniós eljárások meghatározásáról és az Európai Gyógyszerügynökségre irányadó szabályok megállapításáról, az 1394/2007/EK rendelet és az 536/2014/EU rendelet módosításáról, valamint a 726/2004/EK rendelet, a 141/2000/EK rendelet és az 1901/2006/EK rendelet hatályon kívül helyezéséről szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról
REPORT_PLENARY · HU · 4 April 2024
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REPORT on the proposal for a regulation of the European Parliament and of the Council 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
REPORT_PLENARY · EN · 25 March 2024
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REPORT on the proposal for a regulation of the European Parliament and of the Council 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
REPORT_PLENARY · EN · 25 March 2024
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REPORT on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
REPORT_PLENARY · EN · 25 March 2024
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REPORT on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
REPORT_PLENARY · EN · 25 March 2024
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Atzinums par Savienības procedūru noteikšanu attiecībā uz cilvēkiem paredzētu zāļu apstiprināšanu un uzraudzību un Eiropas Zāļu aģentūras reglamentēšanas noteikumu izveidi, Regulas (EK) Nr. 1394/2007 un Regulas (ES) Nr. 536/2014 grozīšanu un Regulas (EK) Nr. 726/2004, Regulas (EK) Nr.141/2000 un Regulas (EK) Nr.1901/2006 atcelšanu (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · LV · 11 March 2024
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Atzinums par Savienības procedūru noteikšanu attiecībā uz cilvēkiem paredzētu zāļu apstiprināšanu un uzraudzību un Eiropas Zāļu aģentūras reglamentēšanas noteikumu izveidi, Regulas (EK) Nr. 1394/2007 un Regulas (ES) Nr. 536/2014 grozīšanu un Regulas (EK) Nr. 726/2004, Regulas (EK) Nr.141/2000 un Regulas (EK) Nr.1901/2006 atcelšanu (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · LV · 11 March 2024
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Nuomonė dėl Komisijos pasiūlymo dėl Europos Parlamento ir Tarybos reglamento dėl žmonėms skirtų vaistų rinkodaros leidimų suteikimo ir priežiūros, kuriuo nustatomos taisyklės, kuriomis reglamentuojama Europos vaistų agentūros veikla (COM(2023)0193); (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · LT · 11 March 2024
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2023%2F0131(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2023-0131
eu · 2023-0131 · source updated 18 March 2026