Clinical trials on medicinal products for human use, and repeal of Directive 2001/20/EC

votedEuropean Union· European Parliament· EN

Introduced

11 September 2012

Last action

27 May 2014 · publication official journal

Status

PLENARY_VOTE

Official titles

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

22 official languages

Bulgarian
Клиничните изпитвания на лекарствени продукти за хуманна употреба и отмяна на Директива 2001/20/ЕО
Czech
Klinická hodnocení humánních léčivých přípravků a zrušení směrnice 2001/20/ES
Danish
Kliniske forsøg med humanmedicinske lægemidler og ophævelse af direktiv 2001/20/EF
German
Klinische Prüfungen mit Humanarzneimitteln und Aufhebung der Richtlinie 2001/20/EG
Greek
Κλινικές δοκιμές φαρμάκων που προορίζονται για τον άνθρωπο και για την κατάργηση της οδηγίας 2001/20/ΕΚ
Spanish
Ensayos clínicos de medicamentos de uso humano y derogación de la Directiva 2001/20/CE
Estonian
Inimtervishoius kasutatavate ravimite kliinilised katsed ja direktiivi 2001/20/EÜ kehtetuks tunnistamine
Finnish
Ihmisille tarkoitettujen lääkkeiden kliiniset lääketutkimukset ja direktiivin 2001/20/EY kumoaminen
French
Essais cliniques de médicaments à usage humain et abrogation de la directive 2001/20/CE
Croatian
Klinička ispitivanja lijekova za ljudsku uporabu i stavljanje izvan snage Direktive 2001/20/EZ
Hungarian
Az emberi felhasználásra szánt gyógyszerek klinikai vizsgálatai és a 2001/20/EK irányelv hatályon kívül helyezése
Italian
Sperimentazione clinica di medicinali per uso umano e abrogazione della direttiva 2001/20/CE
Lithuanian
Žmonėms skirtų vaistų klinikiniai tyrimai ir Direktyvos 2001/20/EB panaikinimas
Latvian
Cilvēkiem paredzētu zāļu klīniskie izmēģinājumi un Direktīvas 2001/20/EK atcelšana
Maltese
Provi kliniċi fuq prodotti mediċinali għall-użu mill-bniedem, u tħassir tad-Direttiva 2001/20/KE
Dutch
Klinische proeven met geneesmiddelen voor menselĳk gebruik en intrekking van Richtlijn 2001/20/EG
Polish
Badania kliniczne produktów leczniczych stosowanych u ludzi oraz uchylenie dyrektywy 2001/20/WE
Portuguese
Ensaios clínicos de medicamentos para uso humano e revogação da Diretiva 2001/20/CE
Romanian
Studiile clinice cu medicamente de uz uman și abrogarea Directivei 2001/20/CE
Slovak
Klinické skúšanie liekov na humánne použitie a zrušenie smernice 2001/20/ES
Slovenian
Klinično preskušanje zdravil za uporabo v humani medicini in razveljavitev Direktive 2001/20/ES
Swedish
Kliniska prövningar av humanläkemedel och upphävande av direktiv 2001/20/EG

Records

Official bill 2012/0192(COD) from European Union at European Parliament. Dated 11 September 2012. Status: PLENARY_VOTE.

Timeline

11 September 2012
referral
Source: REFERRAL
11 September 2012
Introduced
Clinical trials on medicinal products for human use, and repeal of Directive 2001/20/EC
Source: COD
2 April 2014
Vote results
Source: PLENARY_VOTE_RESULTS
2 April 2014
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
16 April 2014
signature
Source: SIGNATURE
27 May 2014
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

No vote records are attached yet.

Versions

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Documents

93 official files

BETÄNKANDE om förslaget till Europaparlamentets och rådets förordning om kliniska prövningar av humanläkemedel och om upphävande av direktiv 2001/20/EG

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BETÄNKANDE om förslaget till Europaparlamentets och rådets förordning om kliniska prövningar av humanläkemedel och om upphävande av direktiv 2001/20/EG
REPORT_PLENARY · SV · 31 January 2018
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BETÄNKANDE om förslaget till Europaparlamentets och rådets förordning om kliniska prövningar av humanläkemedel och om upphävande av direktiv 2001/20/EG
REPORT_PLENARY · SV · 31 January 2018
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BETÄNKANDE om förslaget till Europaparlamentets och rådets förordning om kliniska prövningar av humanläkemedel och om upphävande av direktiv 2001/20/EG
REPORT_PLENARY · SV · 31 January 2018
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POROČILO o predlogu uredbe Evropskega parlamenta in Sveta o kliničnem preskušanju zdravil za uporabo v humani medicini in razveljavitvi Direktive 2001/20/ES
REPORT_PLENARY · SL · 31 January 2018
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POROČILO o predlogu uredbe Evropskega parlamenta in Sveta o kliničnem preskušanju zdravil za uporabo v humani medicini in razveljavitvi Direktive 2001/20/ES
REPORT_PLENARY · SL · 31 January 2018
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SPRÁVA o návrhu nariadenia Európskeho parlamentu a Rady o klinickom skúšaní liekov na humánne použitie, ktorým sa zrušuje smernica 2001/20/ES
REPORT_PLENARY · SK · 31 January 2018
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SPRÁVA o návrhu nariadenia Európskeho parlamentu a Rady o klinickom skúšaní liekov na humánne použitie, ktorým sa zrušuje smernica 2001/20/ES
REPORT_PLENARY · SK · 31 January 2018
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RAPORT referitor la propunerea de regulament al Parlamentului European și al Consiliului privind trialurile clinice cu medicamente de uz uman și de abrogare a Directivei 2001/20/CE
REPORT_PLENARY · RO · 31 January 2018
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RAPORT referitor la propunerea de regulament al Parlamentului European și al Consiliului privind trialurile clinice cu medicamente de uz uman și de abrogare a Directivei 2001/20/CE
REPORT_PLENARY · RO · 31 January 2018
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho relativo aos ensaios clínicos de medicamentos para uso humano e que revoga a Diretiva 2001/20/CE
REPORT_PLENARY · PT · 31 January 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE
REPORT_PLENARY · PL · 31 January 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE
REPORT_PLENARY · PL · 31 January 2018
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VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad betreffende klinische proeven met geneesmiddelen voor menselijk gebruik en tot intrekking van Richtlijn 2001/20/EG
REPORT_PLENARY · NL · 31 January 2018
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VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad betreffende klinische proeven met geneesmiddelen voor menselijk gebruik en tot intrekking van Richtlijn 2001/20/EG
REPORT_PLENARY · NL · 31 January 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill dwar il-provi kliniċi fuq prodotti mediċinali għall-użu mill-bniedem, u li jħassar id-Direttiva 2001/20/KE
REPORT_PLENARY · MT · 31 January 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill dwar il-provi kliniċi fuq prodotti mediċinali għall-użu mill-bniedem, u li jħassar id-Direttiva 2001/20/KE
REPORT_PLENARY · MT · 31 January 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill dwar il-provi kliniċi fuq prodotti mediċinali għall-użu mill-bniedem, u li jħassar id-Direttiva 2001/20/KE
REPORT_PLENARY · MT · 31 January 2018
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes regulai par cilvēkiem paredzētu zāļu klīniskiem izmēģinājumiem un par Direktīvas 2001/20/EK atcelšanu
REPORT_PLENARY · LV · 31 January 2018
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes regulai par cilvēkiem paredzētu zāļu klīniskiem izmēģinājumiem un par Direktīvas 2001/20/EK atcelšanu
REPORT_PLENARY · LV · 31 January 2018
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes regulai par cilvēkiem paredzētu zāļu klīniskiem izmēģinājumiem un par Direktīvas 2001/20/EK atcelšanu
REPORT_PLENARY · LV · 31 January 2018
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PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos reglamento dėl žmonėms skirtų vaistų klinikinių tyrimų, kuriuo panaikinama Direktyva 2001/20/EB
REPORT_PLENARY · LT · 31 January 2018
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PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos reglamento dėl žmonėms skirtų vaistų klinikinių tyrimų, kuriuo panaikinama Direktyva 2001/20/EB
REPORT_PLENARY · LT · 31 January 2018
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PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos reglamento dėl žmonėms skirtų vaistų klinikinių tyrimų, kuriuo panaikinama Direktyva 2001/20/EB
REPORT_PLENARY · LT · 31 January 2018
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RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio concernente la sperimentazione clinica di medicinali per uso umano, e che abroga la direttiva 2001/20/CE
REPORT_PLENARY · IT · 31 January 2018
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RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio concernente la sperimentazione clinica di medicinali per uso umano, e che abroga la direttiva 2001/20/CE
REPORT_PLENARY · IT · 31 January 2018
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JELENTÉS az emberi felhasználásra szánt gyógyszerek klinikai vizsgálatairól és a 2001/20/EK irányelv hatályon kívül helyezéséről szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról
REPORT_PLENARY · HU · 31 January 2018
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JELENTÉS az emberi felhasználásra szánt gyógyszerek klinikai vizsgálatairól és a 2001/20/EK irányelv hatályon kívül helyezéséről szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról
REPORT_PLENARY · HU · 31 January 2018
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IZVJEŠĆE o prijedlogu Uredbe Europskog parlamenta i Vijeća o kliničkim ispitivanjima lijekova za humanu primjenu, te o stavljanju izvan snage Direktive 2001/20/EZ
REPORT_PLENARY · HR · 31 January 2018
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IZVJEŠĆE o prijedlogu Uredbe Europskog parlamenta i Vijeća o kliničkim ispitivanjima lijekova za humanu primjenu, te o stavljanju izvan snage Direktive 2001/20/EZ
REPORT_PLENARY · HR · 31 January 2018
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE
REPORT_PLENARY · FR · 31 January 2018
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE
REPORT_PLENARY · FR · 31 January 2018
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi ihmisille tarkoitettujen lääkkeiden kliinisistä lääketutkimuksista ja direktiivin 2001/20/EY kumoamisesta
REPORT_PLENARY · FI · 31 January 2018
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi ihmisille tarkoitettujen lääkkeiden kliinisistä lääketutkimuksista ja direktiivin 2001/20/EY kumoamisesta
REPORT_PLENARY · FI · 31 January 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles käsitletakse inimtervishoius kasutatavate ravimite kliinilisi uuringuid ja millega tunnistatakse kehtetuks direktiiv 2001/20/EÜ
REPORT_PLENARY · ET · 31 January 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles käsitletakse inimtervishoius kasutatavate ravimite kliinilisi uuringuid ja millega tunnistatakse kehtetuks direktiiv 2001/20/EÜ
REPORT_PLENARY · ET · 31 January 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles käsitletakse inimtervishoius kasutatavate ravimite kliinilisi uuringuid ja millega tunnistatakse kehtetuks direktiiv 2001/20/EÜ
REPORT_PLENARY · ET · 31 January 2018
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INFORME sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo sobre los ensayos clínicos de medicamentos de uso humano, y por el que se deroga la Directiva 2001/20/CE
REPORT_PLENARY · ES · 31 January 2018
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INFORME sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo sobre los ensayos clínicos de medicamentos de uso humano, y por el que se deroga la Directiva 2001/20/CE
REPORT_PLENARY · ES · 31 January 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τις κλινικές δοκιμές φαρμάκων προοριζομένων για τον άνθρωπο και για την κατάργηση της οδηγίας 2001/20/ΕΚ
REPORT_PLENARY · EL · 31 January 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τις κλινικές δοκιμές φαρμάκων προοριζομένων για τον άνθρωπο και για την κατάργηση της οδηγίας 2001/20/ΕΚ
REPORT_PLENARY · EL · 31 January 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τις κλινικές δοκιμές φαρμάκων προοριζομένων για τον άνθρωπο και για την κατάργηση της οδηγίας 2001/20/ΕΚ
REPORT_PLENARY · EL · 31 January 2018
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BERICHT über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG
REPORT_PLENARY · DE · 31 January 2018
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BERICHT über den Vorschlag für eine Verordnung des Europäischen Parlaments und des Rates über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG
REPORT_PLENARY · DE · 31 January 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets forordning om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF
REPORT_PLENARY · DA · 31 January 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets forordning om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF
REPORT_PLENARY · DA · 31 January 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets forordning om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF
REPORT_PLENARY · DA · 31 January 2018
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ZPRÁVA o návrhu nařízení Evropského parlamentu a Rady o klinických hodnoceních humánních léčivých přípravků a o zrušení směrnice 2001/20/ES
REPORT_PLENARY · CS · 31 January 2018
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ZPRÁVA o návrhu nařízení Evropského parlamentu a Rady o klinických hodnoceních humánních léčivých přípravků a o zrušení směrnice 2001/20/ES
REPORT_PLENARY · CS · 31 January 2018
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ДОКЛАД относно предложение за регламент на Европейския парламент и на Съвета относно клиничните изпитвания на лекарствени продукти за хуманна употреба, и за отмяна на Директива 2001/20/ЕО
REPORT_PLENARY · BG · 31 January 2018
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ДОКЛАД относно предложение за регламент на Европейския парламент и на Съвета относно клиничните изпитвания на лекарствени продукти за хуманна употреба, и за отмяна на Директива 2001/20/ЕО
REPORT_PLENARY · BG · 31 January 2018
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2012%2F0192(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2012-0192
eu · 2012-0192 · source updated 27 May 2014