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European Union · Bill · COD

2008/0260(COD)

Pharmacovigilance (amendment of Directive 2001/83/EC)

votedEuropean Union· European Parliament· EN

Introduced

13 January 2009

Last action

25 January 2011 · publication official journal

Status

PLENARY_VOTE

Sponsors

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Subjects

Discovery layer

Source updated

25 January 2011

Official titles

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

21 official languages
  • Bulgarian

    Фармакологична бдителност (изменение на Директива 2001/83/ЕО)

  • Czech

    Farmakovigilance (změna směrnice 2001/83/ES)

  • Danish

    Lægemiddelovervågning (ændring af direktiv 2001/83/EF)

  • German

    Pharmakovigilanz (Änderung der Richtlinie 2001/83/EG)

  • Greek

    Φαρμακοεπαγρύπνηση (τροποποίηση της οδηγίας 2001/83/ΕΚ)

  • Spanish

    Farmacovigilancia (modificación de la Directiva 2001/83/CE)

  • Estonian

    Ravimite ohutus (direktiivi 2001/83/EÜ muutmine)

  • Finnish

    Lääketurvatoiminta (direktiivin 2001/83/EY muuttaminen)

  • French

    Pharmacovigilance (modification de la directive 2001/83/CE)

  • Hungarian

    Farmakovigilancia (a 2001/83/EK irányelv módosítása)

  • Italian

    Farmacovigilanza (modifica della direttiva 2001/83/CE)

  • Lithuanian

    Vaistų priežiūra (Direktyvos 2001/83/EB dalinis keitimas)

  • Latvian

    Farmakovigilance (grozījumi Direktīvā 2001/83/EK)

  • Maltese

    Farmakoviġilanza (emenda tad-Direttiva 2001/83/KE)

  • Dutch

    Geneesmiddelenbewaking (Aanpassing verordening (EG) 726/2004)

  • Polish

    Nadzór nad bezpieczeństwem farmakoterapii (zmiana dyrektywy 2001/83/WE)

  • Portuguese

    Farmacovigilância (alteração da Directiva 2001/83/CE)

  • Romanian

    Farmacovigilența (modificare a Directivei 2001/83/CE)

  • Slovak

    Farmakovigilancia (zmena smernice 2001/83/ES)

  • Slovenian

    Farmakovigilanca (sprememba Direktive 2001/83/ES)

  • Swedish

    Säkerhetsövervakning av läkemedel (ändring av direktiv 2001/83/EG)*

Records

Official bill 2008/0260(COD) from European Union at European Parliament. Dated 13 January 2009. Status: PLENARY_VOTE.

Timeline

  1. 13 January 2009

    referral

    Source: REFERRAL

  2. 13 January 2009

    Introduced

    Pharmacovigilance (amendment of Directive 2001/83/EC)

    Source: COD

  3. 22 September 2010

    plenary amend proposal

    Source: PLENARY_AMEND_PROPOSAL

  4. 22 September 2010

    Vote results

    Source: PLENARY_VOTE_RESULTS

  5. 15 December 2010

    signature

    Source: SIGNATURE

  6. 25 January 2011

    publication official journal

    Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

90 official files

ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai, ar ko farmakovigilances jomā groza Direktīvu 2001/83/EK par Kopienas kodeksu, kas attiecas uz cilvēkiem paredzētām zālēm

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  • ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai, ar ko farmakovigilances jomā groza Direktīvu 2001/83/EK par Kopienas kodeksu, kas attiecas uz cilvēkiem paredzētām zālēm

    REPORT_PLENARY · LV · 6 February 2018

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  • ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai, ar ko farmakovigilances jomā groza Direktīvu 2001/83/EK par Kopienas kodeksu, kas attiecas uz cilvēkiem paredzētām zālēm

    REPORT_PLENARY · LV · 6 February 2018

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  • ZPRÁVA o návrhu směrnice Evropského parlamentu a Rady, kterou se mění směrnice 2001/83/ES o kodexu Společenství týkajícím se humánních léčivých přípravků, pokud jde o farmakovigilanci

    REPORT_PLENARY · CS · 6 February 2018

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  • ZPRÁVA o návrhu směrnice Evropského parlamentu a Rady, kterou se mění směrnice 2001/83/ES o kodexu Společenství týkajícím se humánních léčivých přípravků, pokud jde o farmakovigilanci

    REPORT_PLENARY · CS · 6 February 2018

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  • ZPRÁVA o návrhu směrnice Evropského parlamentu a Rady, kterou se mění směrnice 2001/83/ES o kodexu Společenství týkajícím se humánních léčivých přípravků, pokud jde o farmakovigilanci

    REPORT_PLENARY · CS · 6 February 2018

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  • ZPRÁVA o návrhu směrnice Evropského parlamentu a Rady, kterou se mění směrnice 2001/83/ES o kodexu Společenství týkajícím se humánních léčivých přípravků, pokud jde o farmakovigilanci

    REPORT_PLENARY · CS · 6 February 2018

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  • RAPPORT sur la proposition de directive du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain

    REPORT_PLENARY · FR · 6 February 2018

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  • RAPPORT sur la proposition de directive du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain

    REPORT_PLENARY · FR · 6 February 2018

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  • RAPPORT sur la proposition de directive du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain

    REPORT_PLENARY · FR · 6 February 2018

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  • RAPPORT sur la proposition de directive du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain

    REPORT_PLENARY · FR · 6 February 2018

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  • INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo que modifica, en lo que respecta a la farmacovigilancia, la Directiva 2001/83/CE, por la que se establece un código comunitario sobre medicamentos para uso humano

    REPORT_PLENARY · ES · 6 February 2018

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  • INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo que modifica, en lo que respecta a la farmacovigilancia, la Directiva 2001/83/CE, por la que se establece un código comunitario sobre medicamentos para uso humano

    REPORT_PLENARY · ES · 6 February 2018

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  • INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo que modifica, en lo que respecta a la farmacovigilancia, la Directiva 2001/83/CE, por la que se establece un código comunitario sobre medicamentos para uso humano

    REPORT_PLENARY · ES · 6 February 2018

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  • INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo que modifica, en lo que respecta a la farmacovigilancia, la Directiva 2001/83/CE, por la que se establece un código comunitario sobre medicamentos para uso humano

    REPORT_PLENARY · ES · 6 February 2018

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  • ДОКЛАД относно предложението за директива на Европейския парламент и на Съвета за изменение по отношение на фармакологичната бдителност на Директива 2001/83/ЕО за утвърждаване на кодекс на Общността относно лекарствени продукти за хуманна употреба

    REPORT_PLENARY · BG · 6 February 2018

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  • ДОКЛАД относно предложението за директива на Европейския парламент и на Съвета за изменение по отношение на фармакологичната бдителност на Директива 2001/83/ЕО за утвърждаване на кодекс на Общността относно лекарствени продукти за хуманна употреба

    REPORT_PLENARY · BG · 6 February 2018

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  • ДОКЛАД относно предложението за директива на Европейския парламент и на Съвета за изменение по отношение на фармакологичната бдителност на Директива 2001/83/ЕО за утвърждаване на кодекс на Общността относно лекарствени продукти за хуманна употреба

    REPORT_PLENARY · BG · 6 February 2018

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  • ДОКЛАД относно предложението за директива на Европейския парламент и на Съвета за изменение по отношение на фармакологичната бдителност на Директива 2001/83/ЕО за утвърждаване на кодекс на Общността относно лекарствени продукти за хуманна употреба

    REPORT_PLENARY · BG · 6 February 2018

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  • BETÄNKANDE om förslaget till Europaparlamentets och rådets direktiv om ändring, när det gäller säkerhetsövervakning av humanläkemedel, av direktiv 2001/83/EG om upprättande av gemenskapsregler för humanläkemedel

    REPORT_PLENARY · SV · 6 February 2018

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  • BETÄNKANDE om förslaget till Europaparlamentets och rådets direktiv om ändring, när det gäller säkerhetsövervakning av humanläkemedel, av direktiv 2001/83/EG om upprättande av gemenskapsregler för humanläkemedel

    REPORT_PLENARY · SV · 6 February 2018

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  • BETÄNKANDE om förslaget till Europaparlamentets och rådets direktiv om ändring, när det gäller säkerhetsövervakning av humanläkemedel, av direktiv 2001/83/EG om upprättande av gemenskapsregler för humanläkemedel

    REPORT_PLENARY · SV · 6 February 2018

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  • BETÄNKANDE om förslaget till Europaparlamentets och rådets direktiv om ändring, när det gäller säkerhetsövervakning av humanläkemedel, av direktiv 2001/83/EG om upprättande av gemenskapsregler för humanläkemedel

    REPORT_PLENARY · SV · 6 February 2018

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  • BERICHT über den Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz

    REPORT_PLENARY · DE · 6 February 2018

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  • BERICHT über den Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz

    REPORT_PLENARY · DE · 6 February 2018

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  • BERICHT über den Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz

    REPORT_PLENARY · DE · 6 February 2018

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  • BERICHT über den Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz

    REPORT_PLENARY · DE · 6 February 2018

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  • JELENTÉS az emberi felhasználásra szánt gyógyszerek közösségi kódexéről szóló 2001/83/EK irányelvnek a farmakovigilancia tekintetében történő módosításáról szóló európai parlamenti és tanácsi rendeletre vonatkozó javaslatról

    REPORT_PLENARY · HU · 6 February 2018

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  • JELENTÉS az emberi felhasználásra szánt gyógyszerek közösségi kódexéről szóló 2001/83/EK irányelvnek a farmakovigilancia tekintetében történő módosításáról szóló európai parlamenti és tanácsi rendeletre vonatkozó javaslatról

    REPORT_PLENARY · HU · 6 February 2018

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  • JELENTÉS az emberi felhasználásra szánt gyógyszerek közösségi kódexéről szóló 2001/83/EK irányelvnek a farmakovigilancia tekintetében történő módosításáról szóló európai parlamenti és tanácsi rendeletre vonatkozó javaslatról

    REPORT_PLENARY · HU · 6 February 2018

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  • JELENTÉS az emberi felhasználásra szánt gyógyszerek közösségi kódexéről szóló 2001/83/EK irányelvnek a farmakovigilancia tekintetében történő módosításáról szóló európai parlamenti és tanácsi rendeletre vonatkozó javaslatról

    REPORT_PLENARY · HU · 6 February 2018

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  • PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos, iš dalies keičiančios Direktyvos 2001/83/EB nuostatas dėl Bendrijos kodekso, reglamentuojančio žmonėms skirtus vaistus, nuostatas dėl farmakologinio budrumo

    REPORT_PLENARY · LT · 6 February 2018

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  • PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos, iš dalies keičiančios Direktyvos 2001/83/EB nuostatas dėl Bendrijos kodekso, reglamentuojančio žmonėms skirtus vaistus, nuostatas dėl farmakologinio budrumo

    REPORT_PLENARY · LT · 6 February 2018

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  • PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos, iš dalies keičiančios Direktyvos 2001/83/EB nuostatas dėl Bendrijos kodekso, reglamentuojančio žmonėms skirtus vaistus, nuostatas dėl farmakologinio budrumo

    REPORT_PLENARY · LT · 6 February 2018

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  • PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos, iš dalies keičiančios Direktyvos 2001/83/EB nuostatas dėl Bendrijos kodekso, reglamentuojančio žmonėms skirtus vaistus, nuostatas dėl farmakologinio budrumo

    REPORT_PLENARY · LT · 6 February 2018

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  • RAPORT referitor la propunerea de directivă a Parlamentului European și a Consiliului de modificare, în ceea ce privește farmacovigilența, a Directivei 2001/83/CE de instituire a unui cod comunitar cu privire la medicamentele de uz uman

    REPORT_PLENARY · RO · 6 February 2018

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  • RAPORT referitor la propunerea de directivă a Parlamentului European și a Consiliului de modificare, în ceea ce privește farmacovigilența, a Directivei 2001/83/CE de instituire a unui cod comunitar cu privire la medicamentele de uz uman

    REPORT_PLENARY · RO · 6 February 2018

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  • RAPORT referitor la propunerea de directivă a Parlamentului European și a Consiliului de modificare, în ceea ce privește farmacovigilența, a Directivei 2001/83/CE de instituire a unui cod comunitar cu privire la medicamentele de uz uman

    REPORT_PLENARY · RO · 6 February 2018

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  • RAPORT referitor la propunerea de directivă a Parlamentului European și a Consiliului de modificare, în ceea ce privește farmacovigilența, a Directivei 2001/83/CE de instituire a unui cod comunitar cu privire la medicamentele de uz uman

    REPORT_PLENARY · RO · 6 February 2018

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  • Suite donnée au T7-0332/2010

    ACT_FOLLOWUP · FR · 2 December 2010

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  • Follow up to T7-0332/2010

    ACT_FOLLOWUP · EN · 17 November 2010

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