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

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

13 January 2009
referral
Source: REFERRAL
13 January 2009
Introduced
Pharmacovigilance (amendment of Directive 2001/83/EC)
Source: COD
22 September 2010
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
22 September 2010
Vote results
Source: PLENARY_VOTE_RESULTS
15 December 2010
signature
Source: SIGNATURE
25 January 2011
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

No vote records are attached yet.

Versions

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Documents

90 official files

MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä annetun direktiivin 2001/83/EY muuttamisesta lääketurvatoiminnan osalta

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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä annetun direktiivin 2001/83/EY muuttamisesta lääketurvatoiminnan osalta
REPORT_PLENARY · FI · 6 February 2018
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä annetun direktiivin 2001/83/EY muuttamisesta lääketurvatoiminnan osalta
REPORT_PLENARY · FI · 6 February 2018
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä annetun direktiivin 2001/83/EY muuttamisesta lääketurvatoiminnan osalta
REPORT_PLENARY · FI · 6 February 2018
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä annetun direktiivin 2001/83/EY muuttamisesta lääketurvatoiminnan osalta
REPORT_PLENARY · FI · 6 February 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για την τροποποίηση, όσον αφορά τη φαρμακoεπαγρύπνηση, της οδηγίας 2001/83/ΕΚ περί κοινοτικού κώδικος για τα φάρμακα που προορίζονται για ανθρώπινη χρήση
REPORT_PLENARY · EL · 6 February 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για την τροποποίηση, όσον αφορά τη φαρμακoεπαγρύπνηση, της οδηγίας 2001/83/ΕΚ περί κοινοτικού κώδικος για τα φάρμακα που προορίζονται για ανθρώπινη χρήση
REPORT_PLENARY · EL · 6 February 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για την τροποποίηση, όσον αφορά τη φαρμακoεπαγρύπνηση, της οδηγίας 2001/83/ΕΚ περί κοινοτικού κώδικος για τα φάρμακα που προορίζονται για ανθρώπινη χρήση
REPORT_PLENARY · EL · 6 February 2018
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για την τροποποίηση, όσον αφορά τη φαρμακoεπαγρύπνηση, της οδηγίας 2001/83/ΕΚ περί κοινοτικού κώδικος για τα φάρμακα που προορίζονται για ανθρώπινη χρήση
REPORT_PLENARY · EL · 6 February 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse ravimiohutuse järelevalve osas direktiivi 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta
REPORT_PLENARY · ET · 6 February 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse ravimiohutuse järelevalve osas direktiivi 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta
REPORT_PLENARY · ET · 6 February 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse ravimiohutuse järelevalve osas direktiivi 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta
REPORT_PLENARY · ET · 6 February 2018
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse ravimiohutuse järelevalve osas direktiivi 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta
REPORT_PLENARY · ET · 6 February 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets direktiv om ændring af direktiv 2001/83/EF om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler, for så vidt angår lægemiddelovervågning
REPORT_PLENARY · DA · 6 February 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets direktiv om ændring af direktiv 2001/83/EF om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler, for så vidt angår lægemiddelovervågning
REPORT_PLENARY · DA · 6 February 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets direktiv om ændring af direktiv 2001/83/EF om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler, for så vidt angår lægemiddelovervågning
REPORT_PLENARY · DA · 6 February 2018
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets direktiv om ændring af direktiv 2001/83/EF om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler, for så vidt angår lægemiddelovervågning
REPORT_PLENARY · DA · 6 February 2018
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POROČILO o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakovigilance
REPORT_PLENARY · SL · 6 February 2018
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POROČILO o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakovigilance
REPORT_PLENARY · SL · 6 February 2018
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POROČILO o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakovigilance
REPORT_PLENARY · SL · 6 February 2018
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POROČILO o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakovigilance
REPORT_PLENARY · SL · 6 February 2018
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda, fir-rigward tal-farmakoviġilanza, id-Direttiva 2001/83/KE dwar il-kodiċi Komunitarju relatat mal-prodotti mediċinali għall-użu mill-bniedem
REPORT_PLENARY · MT · 6 February 2018
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda, fir-rigward tal-farmakoviġilanza, id-Direttiva 2001/83/KE dwar il-kodiċi Komunitarju relatat mal-prodotti mediċinali għall-użu mill-bniedem
REPORT_PLENARY · MT · 6 February 2018
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda, fir-rigward tal-farmakoviġilanza, id-Direttiva 2001/83/KE dwar il-kodiċi Komunitarju relatat mal-prodotti mediċinali għall-użu mill-bniedem
REPORT_PLENARY · MT · 6 February 2018
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda, fir-rigward tal-farmakoviġilanza, id-Direttiva 2001/83/KE dwar il-kodiċi Komunitarju relatat mal-prodotti mediċinali għall-użu mill-bniedem
REPORT_PLENARY · MT · 6 February 2018
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica, per quanto concerne la farmacovigilanza, la direttiva 2001/83/CE recante un codice comunitario relativo ai medicinali per uso umano
REPORT_PLENARY · IT · 6 February 2018
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica, per quanto concerne la farmacovigilanza, la direttiva 2001/83/CE recante un codice comunitario relativo ai medicinali per uso umano
REPORT_PLENARY · IT · 6 February 2018
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica, per quanto concerne la farmacovigilanza, la direttiva 2001/83/CE recante un codice comunitario relativo ai medicinali per uso umano
REPORT_PLENARY · IT · 6 February 2018
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica, per quanto concerne la farmacovigilanza, la direttiva 2001/83/CE recante un codice comunitario relativo ai medicinali per uso umano
REPORT_PLENARY · IT · 6 February 2018
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RELATÓRIO sobre a proposta de directiva do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância, a Directiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano
REPORT_PLENARY · PT · 6 February 2018
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RELATÓRIO sobre a proposta de directiva do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância, a Directiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano
REPORT_PLENARY · PT · 6 February 2018
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RELATÓRIO sobre a proposta de directiva do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância, a Directiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano
REPORT_PLENARY · PT · 6 February 2018
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RELATÓRIO sobre a proposta de directiva do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância, a Directiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano
REPORT_PLENARY · PT · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego dyrektywy Parlamentu Europejskiego i Rady zmieniającej dyrektywę 2001/83/WE w sprawie wspólnotowego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi w zakresie nadzoru nad bezpieczeństwem farmakoterapii
REPORT_PLENARY · PL · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego dyrektywy Parlamentu Europejskiego i Rady zmieniającej dyrektywę 2001/83/WE w sprawie wspólnotowego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi w zakresie nadzoru nad bezpieczeństwem farmakoterapii
REPORT_PLENARY · PL · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego dyrektywy Parlamentu Europejskiego i Rady zmieniającej dyrektywę 2001/83/WE w sprawie wspólnotowego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi w zakresie nadzoru nad bezpieczeństwem farmakoterapii
REPORT_PLENARY · PL · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego dyrektywy Parlamentu Europejskiego i Rady zmieniającej dyrektywę 2001/83/WE w sprawie wspólnotowego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi w zakresie nadzoru nad bezpieczeństwem farmakoterapii
REPORT_PLENARY · PL · 6 February 2018
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SPRÁVA o návrhu smernice Európskeho parlamentu a Rady, ktorou sa mení a dopĺňa smernica 2001/83/ES, ktorou sa ustanovuje zákonník Spoločenstva o humánnych liekoch, pokiaľ ide o farmakovigilanciu
REPORT_PLENARY · SK · 6 February 2018
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SPRÁVA o návrhu smernice Európskeho parlamentu a Rady, ktorou sa mení a dopĺňa smernica 2001/83/ES, ktorou sa ustanovuje zákonník Spoločenstva o humánnych liekoch, pokiaľ ide o farmakovigilanciu
REPORT_PLENARY · SK · 6 February 2018
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SPRÁVA o návrhu smernice Európskeho parlamentu a Rady, ktorou sa mení a dopĺňa smernica 2001/83/ES, ktorou sa ustanovuje zákonník Spoločenstva o humánnych liekoch, pokiaľ ide o farmakovigilanciu
REPORT_PLENARY · SK · 6 February 2018
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SPRÁVA o návrhu smernice Európskeho parlamentu a Rady, ktorou sa mení a dopĺňa smernica 2001/83/ES, ktorou sa ustanovuje zákonník Spoločenstva o humánnych liekoch, pokiaľ ide o farmakovigilanciu
REPORT_PLENARY · SK · 6 February 2018
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REPORT on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
REPORT_PLENARY · EN · 6 February 2018
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REPORT on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
REPORT_PLENARY · EN · 6 February 2018
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REPORT on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
REPORT_PLENARY · EN · 6 February 2018
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REPORT on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
REPORT_PLENARY · EN · 6 February 2018
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VERSLAG inzake het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking betreft, van Richtlijn 2001/83/EG tot vaststelling van een communautair wetboek betreffende geneesmiddelen voor menselijk gebruik
REPORT_PLENARY · NL · 6 February 2018
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VERSLAG inzake het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking betreft, van Richtlijn 2001/83/EG tot vaststelling van een communautair wetboek betreffende geneesmiddelen voor menselijk gebruik
REPORT_PLENARY · NL · 6 February 2018
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VERSLAG inzake het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking betreft, van Richtlijn 2001/83/EG tot vaststelling van een communautair wetboek betreffende geneesmiddelen voor menselijk gebruik
REPORT_PLENARY · NL · 6 February 2018
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VERSLAG inzake het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking betreft, van Richtlijn 2001/83/EG tot vaststelling van een communautair wetboek betreffende geneesmiddelen voor menselijk gebruik
REPORT_PLENARY · NL · 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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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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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2008%2F0260(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2008-0260
eu · 2008-0260 · source updated 25 January 2011