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

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)).

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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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Opinión sobre la propuesta de la Comisión relativa al Reglamento del Parlamento Europeo y del Consejo por el que se establecen los procedimientos de la Unión para la autorización y el control de los medicamentos de uso humano y se establecen las normas por las que se rige la Agencia Europea de Medicamentos (COM(2023)0193; (2023/0131(COD))
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · ES · 11 March 2024
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Opinión sobre la propuesta de la Comisión relativa al Reglamento del Parlamento Europeo y del Consejo por el que se establecen los procedimientos de la Unión para la autorización y el control de los medicamentos de uso humano y se establecen las normas por las que se rige la Agencia Europea de Medicamentos (COM(2023)0193; (2023/0131(COD))
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · ES · 11 March 2024
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Advies inzake het voorstel van de Commissie over een verordening van het Europees Parlement en de Raad betreffende het verlenen van vergunningen en het toezicht met betrekking tot geneesmiddelen voor menselijk gebruik en tot vaststelling van regels voor het Europees Geneesmiddelenbureau
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · NL · 11 March 2024
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Advies inzake het voorstel van de Commissie over een verordening van het Europees Parlement en de Raad betreffende het verlenen van vergunningen en het toezicht met betrekking tot geneesmiddelen voor menselijk gebruik en tot vaststelling van regels voor het Europees Geneesmiddelenbureau
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · NL · 11 March 2024
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Lausunto komission ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi ihmisille tarkoitettuja lääkkeitä koskevista lupa- ja valvontamenettelyistä ja Euroopan lääkevirastoa koskevista säännöistä COM(2023)0193 – (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · FI · 11 March 2024
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Lausunto komission ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi ihmisille tarkoitettuja lääkkeitä koskevista lupa- ja valvontamenettelyistä ja Euroopan lääkevirastoa koskevista säännöistä COM(2023)0193 – (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · FI · 11 March 2024
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Yttrande om kommissionens förslag till Europaparlamentets och rådets förordning om inrättande av unionsförfaranden för godkännande av och tillsyn över humanläkemedel och om fastställande av regler för Europeiska läkemedelsmyndigheten COM(2023)0193 (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · SV · 11 March 2024
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Yttrande om kommissionens förslag till Europaparlamentets och rådets förordning om inrättande av unionsförfaranden för godkännande av och tillsyn över humanläkemedel och om fastställande av regler för Europeiska läkemedelsmyndigheten COM(2023)0193 (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · SV · 11 March 2024
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Vélemény az emberi alkalmazásra szánt gyógyszerek uniós szintű engedélyezésére és felügyeletére vonatkozó uniós eljárások meghatározásáról és az Európai Gyógyszerügynökségre irányadó szabályok megállapításáról szóló rendeletre irányuló bizottsági javaslatról (COM(2023)0193) (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · HU · 11 March 2024
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Vélemény az emberi alkalmazásra szánt gyógyszerek uniós szintű engedélyezésére és felügyeletére vonatkozó uniós eljárások meghatározásáról és az Európai Gyógyszerügynökségre irányadó szabályok megállapításáról szóló rendeletre irányuló bizottsági javaslatról (COM(2023)0193) (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · HU · 11 March 2024
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Mišljenje o Mišljenju o Komisijinu Prijedlogu uredbe Europskog parlamenta i Vijeća o odobravanju i nadzoru lijekova za humanu primjenu i o utvrđivanju pravila o Europskoj agenciji za lijekove
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · HR · 11 March 2024
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Mišljenje o Mišljenju o Komisijinu Prijedlogu uredbe Europskog parlamenta i Vijeća o odobravanju i nadzoru lijekova za humanu primjenu i o utvrđivanju pravila o Europskoj agenciji za lijekove
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · HR · 11 March 2024
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Aviz referitor la propunerea Comisiei de regulament al Parlamentului European și al Consiliului de stabilire a procedurilor la nivelul Uniunii privind autorizarea și supravegherea medicamentelor de uz uman și stabilirea normelor care reglementează Agenția Europeană pentru Medicamente
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · RO · 11 March 2024
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Aviz referitor la propunerea Comisiei de regulament al Parlamentului European și al Consiliului de stabilire a procedurilor la nivelul Uniunii privind autorizarea și supravegherea medicamentelor de uz uman și stabilirea normelor care reglementează Agenția Europeană pentru Medicamente
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · RO · 11 March 2024
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Stanovisko k návrhu Komisie na nariadenie Európskeho parlamentu a Rady, ktorým sa stanovujú postupy Únie pri povoľovaní liekov na humánne použitie a vykonávaní dozoru nad nimi a určujú pravidlá platné pre Európsku agentúru pre lieky COM(2023) 193; (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · SK · 11 March 2024
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Stanovisko k návrhu Komisie na nariadenie Európskeho parlamentu a Rady, ktorým sa stanovujú postupy Únie pri povoľovaní liekov na humánne použitie a vykonávaní dozoru nad nimi a určujú pravidlá platné pre Európsku agentúru pre lieky COM(2023) 193; (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · SK · 11 March 2024
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Parere sulla proposta della Commissione di regolamento del Parlamento europeo e del Consiglio che stabilisce le procedure dell'Unione per l'autorizzazione e la sorveglianza dei medicinali per uso umano e definisce le norme che disciplinano l'Agenzia europea per i medicinali (COM(2023)0193 – 2023/0131(COD))
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · IT · 11 March 2024
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Parere sulla proposta della Commissione di regolamento del Parlamento europeo e del Consiglio che stabilisce le procedure dell'Unione per l'autorizzazione e la sorveglianza dei medicinali per uso umano e definisce le norme che disciplinano l'Agenzia europea per i medicinali (COM(2023)0193 – 2023/0131(COD))
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · IT · 11 March 2024
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Opinia w sprawie opinii w sprawie wniosku Komisji dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i nadzoru nad nimi oraz ustanawiającego zasady regulujące działalność Europejskiej Agencji Leków, COM(2023)0193 (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · PL · 11 March 2024
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Opinia w sprawie opinii w sprawie wniosku Komisji dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i nadzoru nad nimi oraz ustanawiającego zasady regulujące działalność Europejskiej Agencji Leków, COM(2023)0193 (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · PL · 11 March 2024
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Γνωμοδότηση σχετικά με την πρόταση της Επιτροπής για κανονισμό 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 COM(2023)0193· (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · EL · 11 March 2024
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Γνωμοδότηση σχετικά με την πρόταση της Επιτροπής για κανονισμό 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 COM(2023)0193· (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · EL · 11 March 2024
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Stellungnahme zu dem Vorschlag der Kommission für eine Verordnung des Europäischen Parlaments und des Rates zur Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und zur Festlegung von Vorschriften für die Europäische Arzneimittel-Agentur (COM(2023)0193 – 2023/0131(COD))
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · DE · 9 March 2024
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Stellungnahme zu dem Vorschlag der Kommission für eine Verordnung des Europäischen Parlaments und des Rates zur Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und zur Festlegung von Vorschriften für die Europäische Arzneimittel-Agentur (COM(2023)0193 – 2023/0131(COD))
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · DE · 9 March 2024
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NUOMONĖ dėl pasiūlymo dėl Europos Parlamento ir Tarybos reglamento, kuriuo nustatomos Sąjungos žmonėms skirtų vaistų rinkodaros leidimų suteikimo ir priežiūros procedūros ir taisyklės, kuriomis reglamentuojama Europos vaistų agentūros veikla, iš dalies keičiamas Reglamentas (EB) Nr. 1394/2007 ir Reglamentas (ES) Nr. 536/2014 ir panaikinamas Reglamentas (EB) Nr. 726/2004, Reglamentas (EB) Nr. 141/2000 ir Reglamentas (EB) Nr. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · LT · 8 March 2024
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NUOMONĖ dėl pasiūlymo dėl Europos Parlamento ir Tarybos reglamento, kuriuo nustatomos Sąjungos žmonėms skirtų vaistų rinkodaros leidimų suteikimo ir priežiūros procedūros ir taisyklės, kuriomis reglamentuojama Europos vaistų agentūros veikla, iš dalies keičiamas Reglamentas (EB) Nr. 1394/2007 ir Reglamentas (ES) Nr. 536/2014 ir panaikinamas Reglamentas (EB) Nr. 726/2004, Reglamentas (EB) Nr. 141/2000 ir Reglamentas (EB) Nr. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · LT · 8 March 2024
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YTTRANDE över förslaget till Europaparlamentets och rådets förordning om inrättande av unionsförfaranden för godkännande av och tillsyn över humanläkemedel och om fastställande av regler för Europeiska läkemedelsmyndigheten samt om ändring av förordning (EG) nr 1394/2007 och förordning (EU) nr 536/2014 och om upphävande av förordning (EG) nr 726/2004, förordning (EG) nr 141/2000 och förordning (EG) nr 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · SV · 8 March 2024
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YTTRANDE över förslaget till Europaparlamentets och rådets förordning om inrättande av unionsförfaranden för godkännande av och tillsyn över humanläkemedel och om fastställande av regler för Europeiska läkemedelsmyndigheten samt om ändring av förordning (EG) nr 1394/2007 och förordning (EU) nr 536/2014 och om upphävande av förordning (EG) nr 726/2004, förordning (EG) nr 141/2000 och förordning (EG) nr 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · SV · 8 March 2024
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Avis sur la proposition de la Commission relative au 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
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · FR · 8 March 2024
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Avis sur la proposition de la Commission relative au 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
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · FR · 8 March 2024
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ADVIES inzake 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
OPINION_PARLIAMENTARY_COMMITTEE · NL · 8 March 2024
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ADVIES inzake 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
OPINION_PARLIAMENTARY_COMMITTEE · NL · 8 March 2024
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TUAIRIM ar an togra le haghaidh Rialachán ó Pharlaimint na hEorpa agus ón gComhairle lena leagtar síos nósanna imeachta Aontais maidir le húdarú táirgí íocshláinte lena n-úsáid ag an duine agus maoirseacht a dhéanamh orthu 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
OPINION_PARLIAMENTARY_COMMITTEE · GA · 8 March 2024
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TUAIRIM ar an togra le haghaidh Rialachán ó Pharlaimint na hEorpa agus ón gComhairle lena leagtar síos nósanna imeachta Aontais maidir le húdarú táirgí íocshláinte lena n-úsáid ag an duine agus maoirseacht a dhéanamh orthu 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
OPINION_PARLIAMENTARY_COMMITTEE · GA · 8 March 2024
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OPINIÓN sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo por el que se establecen los procedimientos de la Unión para la autorización y el control de los medicamentos de uso humano, se establecen las normas por las que se rige la Agencia Europea de Medicamentos, se modifican el Reglamento (CE) n.º 1394/2007 y el Reglamento (UE) n.º 536/2014 y se derogan el Reglamento (CE) n.º 726/2004, el Reglamento (CE) n.º 141/2000 y el Reglamento (CE) n.º 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · ES · 8 March 2024
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OPINIÓN sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo por el que se establecen los procedimientos de la Unión para la autorización y el control de los medicamentos de uso humano, se establecen las normas por las que se rige la Agencia Europea de Medicamentos, se modifican el Reglamento (CE) n.º 1394/2007 y el Reglamento (UE) n.º 536/2014 y se derogan el Reglamento (CE) n.º 726/2004, el Reglamento (CE) n.º 141/2000 y el Reglamento (CE) n.º 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · ES · 8 March 2024
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STANOVISKO k návrhu nariadenia Európskeho parlamentu a Rady, ktorým sa stanovujú postupy Únie pri povoľovaní liekov na humánne použitie a vykonávaní dozoru nad nimi a určujú pravidlá platné pre Európsku agentúru pre lieky a ktorým sa mení nariadenie (ES) č. 1394/2007 a nariadenie (EÚ) č. 536/2014 a zrušuje nariadenie (ES) č. 726/2004, nariadenie (ES) č. 141/2000 a nariadenie (ES) č. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · SK · 8 March 2024
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STANOVISKO k návrhu nariadenia Európskeho parlamentu a Rady, ktorým sa stanovujú postupy Únie pri povoľovaní liekov na humánne použitie a vykonávaní dozoru nad nimi a určujú pravidlá platné pre Európsku agentúru pre lieky a ktorým sa mení nariadenie (ES) č. 1394/2007 a nariadenie (EÚ) č. 536/2014 a zrušuje nariadenie (ES) č. 726/2004, nariadenie (ES) č. 141/2000 a nariadenie (ES) č. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · SK · 8 March 2024
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Parecer sobre a proposta da Comissão relativa a um 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, COM(2023)0193; (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · PT · 8 March 2024
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Parecer sobre a proposta da Comissão relativa a um 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, COM(2023)0193; (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · PT · 8 March 2024
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ARVAMUS mis käsitleb ettepanekut 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
OPINION_PARLIAMENTARY_COMMITTEE · ET · 8 March 2024
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ARVAMUS mis käsitleb ettepanekut 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
OPINION_PARLIAMENTARY_COMMITTEE · ET · 8 March 2024
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AVIZ referitor la propunerea de regulament al Parlamentului European și al Consiliului de stabilire a procedurilor la nivelul Uniunii privind autorizarea și supravegherea medicamentelor de uz uman și de stabilire a normelor care reglementează Agenția Europeană pentru Medicamente, de modificare a Regulamentului (CE) nr. 1394/2007 și a Regulamentului (UE) nr. 536/2014 și de abrogare a Regulamentului (CE) nr. 726/2004, a Regulamentului (CE) nr. 141/2000 și a Regulamentului (CE) nr. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · RO · 8 March 2024
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AVIZ referitor la propunerea de regulament al Parlamentului European și al Consiliului de stabilire a procedurilor la nivelul Uniunii privind autorizarea și supravegherea medicamentelor de uz uman și de stabilire a normelor care reglementează Agenția Europeană pentru Medicamente, de modificare a Regulamentului (CE) nr. 1394/2007 și a Regulamentului (UE) nr. 536/2014 și de abrogare a Regulamentului (CE) nr. 726/2004, a Regulamentului (CE) nr. 141/2000 și a Regulamentului (CE) nr. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · RO · 8 March 2024
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STELLUNGNAHME über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und zur Festlegung von Vorschriften für die Europäische Arzneimittel-Agentur, zur Änderung der Verordnung (EG) Nr. 1394/2007 und der Verordnung (EU) Nr. 536/2014 sowie zur Aufhebung der Verordnung (EG) Nr. 726/2004, der Verordnung (EG) Nr. 141/2000 und der Verordnung (EG) Nr. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · DE · 8 March 2024
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STELLUNGNAHME über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates zur Festlegung der Verfahren der Union für die Zulassung und Überwachung von Humanarzneimitteln und zur Festlegung von Vorschriften für die Europäische Arzneimittel-Agentur, zur Änderung der Verordnung (EG) Nr. 1394/2007 und der Verordnung (EU) Nr. 536/2014 sowie zur Aufhebung der Verordnung (EG) Nr. 726/2004, der Verordnung (EG) Nr. 141/2000 und der Verordnung (EG) Nr. 1901/2006
OPINION_PARLIAMENTARY_COMMITTEE · DE · 8 March 2024
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OPINIA 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
OPINION_PARLIAMENTARY_COMMITTEE · PL · 8 March 2024
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OPINIA 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
OPINION_PARLIAMENTARY_COMMITTEE · PL · 8 March 2024
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Stanovisko k návrhu nařízení Evropského parlamentu a Rady o postupech pro registraci humánních léčivých přípravků a dozor nad nimi a pravidlech pro Evropskou agenturu pro léčivé přípravky, který předložila Komise (COM(2023)0193) (2023/0131(COD)).
OPINION_LETTER_PARLIAMENTARY_COMMITTEE · CS · 8 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