Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004)

votedEuropean Union· European Parliament· EN

Introduced

13 January 2009

Last action

31 December 2010 · 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 за лекарствените продукти (изменение на Регламент (ЕО) № 726/2004)
Czech
Farmakovigilance léčivých přípravků (změna nařízení (ES) č. 726/2004)
Danish
Lægemiddelovervågning (ændring af forordning (EF) nr. 726/2004)
German
Pharmakovigilanz von Humanarzneimitteln (Änderung der Verordnung (EG) Nr. 726/2004)
Greek
Φαρμακοεπαγρύπνηση (τροποποίηση του κανονισμού (ΕΚ) αριθ. 726/2004)
Spanish
Farmacovigilancia de los medicamentos (modificación del Reglamento (CE) nº 726/2004)
Estonian
Ravimite ohutus (määruse (EÜ) nr 726/2004 muutmine)
Finnish
Lääketurvatoiminta (asetuksen (EY) N:o 726/2004 muuttaminen)
French
Pharmacovigilance des médicaments (modification du règlement (CE) n° 726/2004)
Hungarian
A gyógyszerek farmakovigilanciája (a 726/2004/EK rendelet módosítása)
Italian
Sorveglianza dei medicinali (modifica del regolamento (CE) n. 726/2004)
Lithuanian
Vaistų priežiūra (Reglamento (EB) Nr. 726/2004 dalinis keitimas)
Latvian
Cilvēkiem paredzēto zāļu farmakovigilance (grozījumi Regulā (EK) Nr. 726/2004)
Maltese
Farmakoviġilanza tal-prodotti mediċinali (emenda tar-Regolament (KE) Nru 726/2004)
Dutch
Geneesmiddelenbewaking (aanpassing verordening (EG) nr. 726/2004)
Polish
Nadzór nad bezpieczeństwem farmakoterapii w odniesieniu do produktów leczniczych (zmiana rozporządzenia (WE) nr 726/2004)
Portuguese
Farmacovigilância dos medicamentos (alteração do Regulamento (CE) n.º 726/2004)
Romanian
Farmacovigilența medicamentelor (modificare a Regulamentului (CE) nr. 726/2004)
Slovak
Farmakovigilancia liekov (zmena nariadenia (ES) č. 726/2004)
Slovenian
Farmakovigilanca zdravil (sprememba Uredbe (ES) št. 726/2004)
Swedish
Säkerhetsövervakning av läkemedel (ändring av förordning (EG) nr 726/2004)*

Records

Official bill 2008/0257(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 of medicinal products (amendment of Regulation (EC) No 726/2004)
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
31 December 2010
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

VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking van geneesmiddelen voor menselijk gebruik betreft, van Verordening (EG) nr. 726/2004 tot vaststelling van communautaire procedures voor het verlenen van vergunningen en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Geneesmiddelenbureau

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VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking van geneesmiddelen voor menselijk gebruik betreft, van Verordening (EG) nr. 726/2004 tot vaststelling van communautaire procedures voor het verlenen van vergunningen en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Geneesmiddelenbureau
REPORT_PLENARY · NL · 6 February 2018
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VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad tot wijziging, wat de geneesmiddelenbewaking van geneesmiddelen voor menselijk gebruik betreft, van Verordening (EG) nr. 726/2004 tot vaststelling van communautaire procedures voor het verlenen van vergunningen en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Geneesmiddelenbureau
REPORT_PLENARY · NL · 6 February 2018
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance des médicaments à usage humain, le règlement (CE) n° 726/2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments
REPORT_PLENARY · FR · 6 February 2018
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance des médicaments à usage humain, le règlement (CE) n° 726/2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments
REPORT_PLENARY · FR · 6 February 2018
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance des médicaments à usage humain, le règlement (CE) n° 726/2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments
REPORT_PLENARY · FR · 6 February 2018
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RAPPORT sur la proposition de règlement du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance des médicaments à usage humain, le règlement (CE) n° 726/2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments
REPORT_PLENARY · FR · 6 February 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill li jemenda, fir-rigward il-farmakoviġilanza tal-prodotti mediċinali għall-użu tal-bniedem, ir-Regolament (KE) Nru 726/2004 li jistabbilixxi proċeduri Komunitarji għall-awtorizzazzjoni u s-sorveljanza ta' prodotti mediċinali għall-użu mill-bniedem u veterinarju u li jistabbilixxi l-Aġenzija Ewropea għall-Mediċini
REPORT_PLENARY · MT · 6 February 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill li jemenda, fir-rigward il-farmakoviġilanza tal-prodotti mediċinali għall-użu tal-bniedem, ir-Regolament (KE) Nru 726/2004 li jistabbilixxi proċeduri Komunitarji għall-awtorizzazzjoni u s-sorveljanza ta' prodotti mediċinali għall-użu mill-bniedem u veterinarju u li jistabbilixxi l-Aġenzija Ewropea għall-Mediċini
REPORT_PLENARY · MT · 6 February 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill li jemenda, fir-rigward il-farmakoviġilanza tal-prodotti mediċinali għall-użu tal-bniedem, ir-Regolament (KE) Nru 726/2004 li jistabbilixxi proċeduri Komunitarji għall-awtorizzazzjoni u s-sorveljanza ta' prodotti mediċinali għall-użu mill-bniedem u veterinarju u li jistabbilixxi l-Aġenzija Ewropea għall-Mediċini
REPORT_PLENARY · MT · 6 February 2018
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RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill li jemenda, fir-rigward il-farmakoviġilanza tal-prodotti mediċinali għall-użu tal-bniedem, ir-Regolament (KE) Nru 726/2004 li jistabbilixxi proċeduri Komunitarji għall-awtorizzazzjoni u s-sorveljanza ta' prodotti mediċinali għall-użu mill-bniedem u veterinarju u li jistabbilixxi l-Aġenzija Ewropea għall-Mediċini
REPORT_PLENARY · MT · 6 February 2018
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância dos medicamentos para uso humano, o Regulamento (CE) n.º 726/2004 que estabelece procedimentos comunitários de autorização e de fiscalização de medicamentos para uso humano e veterinário e que institui uma Agência Europeia de Medicamentos
REPORT_PLENARY · PT · 6 February 2018
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância dos medicamentos para uso humano, o Regulamento (CE) n.º 726/2004 que estabelece procedimentos comunitários de autorização e de fiscalização de medicamentos para uso humano e veterinário e que institui uma Agência Europeia de Medicamentos
REPORT_PLENARY · PT · 6 February 2018
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância dos medicamentos para uso humano, o Regulamento (CE) n.º 726/2004 que estabelece procedimentos comunitários de autorização e de fiscalização de medicamentos para uso humano e veterinário e que institui uma Agência Europeia de Medicamentos
REPORT_PLENARY · PT · 6 February 2018
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RELATÓRIO sobre a proposta de regulamento do Parlamento Europeu e do Conselho que altera, no que diz respeito à farmacovigilância dos medicamentos para uso humano, o Regulamento (CE) n.º 726/2004 que estabelece procedimentos comunitários de autorização e de fiscalização de medicamentos para uso humano e veterinário e que institui uma Agência Europeia de Medicamentos
REPORT_PLENARY · PT · 6 February 2018
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RAPORT referitor la propunerea de regulament al Parlamentului European şi al Consiliului de modificare, în ceea ce priveşte farmacovigilenţa medicamentelor de uz uman, a Regulamentului (CE) nr. 726/2004 de stabilire a procedurilor comunitare privind autorizarea şi supravegherea medicamentelor de uz uman şi veterinar şi de instituire a unei Agenţii Europene pentru Medicamente
REPORT_PLENARY · RO · 6 February 2018
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RAPORT referitor la propunerea de regulament al Parlamentului European şi al Consiliului de modificare, în ceea ce priveşte farmacovigilenţa medicamentelor de uz uman, a Regulamentului (CE) nr. 726/2004 de stabilire a procedurilor comunitare privind autorizarea şi supravegherea medicamentelor de uz uman şi veterinar şi de instituire a unei Agenţii Europene pentru Medicamente
REPORT_PLENARY · RO · 6 February 2018
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RAPORT referitor la propunerea de regulament al Parlamentului European şi al Consiliului de modificare, în ceea ce priveşte farmacovigilenţa medicamentelor de uz uman, a Regulamentului (CE) nr. 726/2004 de stabilire a procedurilor comunitare privind autorizarea şi supravegherea medicamentelor de uz uman şi veterinar şi de instituire a unei Agenţii Europene pentru Medicamente
REPORT_PLENARY · RO · 6 February 2018
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RAPORT referitor la propunerea de regulament al Parlamentului European şi al Consiliului de modificare, în ceea ce priveşte farmacovigilenţa medicamentelor de uz uman, a Regulamentului (CE) nr. 726/2004 de stabilire a procedurilor comunitare privind autorizarea şi supravegherea medicamentelor de uz uman şi veterinar şi de instituire a unei Agenţii Europene pentru Medicamente
REPORT_PLENARY · RO · 6 February 2018
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RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio che modifica, per quanto riguarda la farmacovigilanza dei medicinali per uso umano, il regolamento (CE) n. 726/2004 che istituisce procedure comunitarie per l’autorizzazione e la sorveglianza dei medicinali per uso umano e veterinario, e che istituisce l’agenzia europea per i medicinali
REPORT_PLENARY · IT · 6 February 2018
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RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio che modifica, per quanto riguarda la farmacovigilanza dei medicinali per uso umano, il regolamento (CE) n. 726/2004 che istituisce procedure comunitarie per l’autorizzazione e la sorveglianza dei medicinali per uso umano e veterinario, e che istituisce l’agenzia europea per i medicinali
REPORT_PLENARY · IT · 6 February 2018
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RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio che modifica, per quanto riguarda la farmacovigilanza dei medicinali per uso umano, il regolamento (CE) n. 726/2004 che istituisce procedure comunitarie per l’autorizzazione e la sorveglianza dei medicinali per uso umano e veterinario, e che istituisce l’agenzia europea per i medicinali
REPORT_PLENARY · IT · 6 February 2018
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RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio che modifica, per quanto riguarda la farmacovigilanza dei medicinali per uso umano, il regolamento (CE) n. 726/2004 che istituisce procedure comunitarie per l’autorizzazione e la sorveglianza dei medicinali per uso umano e veterinario, e che istituisce l’agenzia europea per i medicinali
REPORT_PLENARY · IT · 6 February 2018
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JELENTÉS az emberi, illetve állatgyógyászati felhasználásra szánt gyógyszerek engedélyezésére és felügyeletére vonatkozó közösségi eljárások meghatározásáról és az Európai Gyógyszerügynökség létrehozásáról szóló 726/2004/EK rendeletnek az emberi felhasználásra szánt gyógyszerekkel összefüggésben követendő 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, illetve állatgyógyászati felhasználásra szánt gyógyszerek engedélyezésére és felügyeletére vonatkozó közösségi eljárások meghatározásáról és az Európai Gyógyszerügynökség létrehozásáról szóló 726/2004/EK rendeletnek az emberi felhasználásra szánt gyógyszerekkel összefüggésben követendő 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, illetve állatgyógyászati felhasználásra szánt gyógyszerek engedélyezésére és felügyeletére vonatkozó közösségi eljárások meghatározásáról és az Európai Gyógyszerügynökség létrehozásáról szóló 726/2004/EK rendeletnek az emberi felhasználásra szánt gyógyszerekkel összefüggésben követendő 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, illetve állatgyógyászati felhasználásra szánt gyógyszerek engedélyezésére és felügyeletére vonatkozó közösségi eljárások meghatározásáról és az Európai Gyógyszerügynökség létrehozásáról szóló 726/2004/EK rendeletnek az emberi felhasználásra szánt gyógyszerekkel összefüggésben követendő farmakovigilancia tekintetében történő módosításáról szóló európai parlamenti és tanácsi rendeletre vonatkozó javaslatról
REPORT_PLENARY · HU · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady zmieniającego rozporządzenie (WE) nr 726/2004 ustanawiające wspólnotowe procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i do celów weterynaryjnych i nadzoru nad nimi oraz ustanawiające Europejską Agencję Leków, odnośnie do nadzoru nad bezpieczeństwem farmakoterapii w odniesieniu do produktów leczniczych stosowanych u ludzi
REPORT_PLENARY · PL · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady zmieniającego rozporządzenie (WE) nr 726/2004 ustanawiające wspólnotowe procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i do celów weterynaryjnych i nadzoru nad nimi oraz ustanawiające Europejską Agencję Leków, odnośnie do nadzoru nad bezpieczeństwem farmakoterapii w odniesieniu do produktów leczniczych stosowanych u ludzi
REPORT_PLENARY · PL · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady zmieniającego rozporządzenie (WE) nr 726/2004 ustanawiające wspólnotowe procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i do celów weterynaryjnych i nadzoru nad nimi oraz ustanawiające Europejską Agencję Leków, odnośnie do nadzoru nad bezpieczeństwem farmakoterapii w odniesieniu do produktów leczniczych stosowanych u ludzi
REPORT_PLENARY · PL · 6 February 2018
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SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady zmieniającego rozporządzenie (WE) nr 726/2004 ustanawiające wspólnotowe procedury wydawania pozwoleń dla produktów leczniczych stosowanych u ludzi i do celów weterynaryjnych i nadzoru nad nimi oraz ustanawiające Europejską Agencję Leków, odnośnie do nadzoru nad bezpieczeństwem farmakoterapii w odniesieniu do produktów leczniczych stosowanych u ludzi
REPORT_PLENARY · PL · 6 February 2018
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SPRÁVA o návrhu nariadenia Európskeho parlamentu a Rady, ktorým sa mení a dopĺňa, pokiaľ ide o farmakovigilanciu humánnych liekov, nariadenie (ES) č. 726/2004, ktorým sa stanovujú postupy Spoločenstva pri povoľovaní liekov na humánne použitie a na veterinárne použitie a pri vykonávaní dozoru nad týmito liekmi a ktorým sa zriaďuje Európska agentúra pre lieky
REPORT_PLENARY · SK · 6 February 2018
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SPRÁVA o návrhu nariadenia Európskeho parlamentu a Rady, ktorým sa mení a dopĺňa, pokiaľ ide o farmakovigilanciu humánnych liekov, nariadenie (ES) č. 726/2004, ktorým sa stanovujú postupy Spoločenstva pri povoľovaní liekov na humánne použitie a na veterinárne použitie a pri vykonávaní dozoru nad týmito liekmi a ktorým sa zriaďuje Európska agentúra pre lieky
REPORT_PLENARY · SK · 6 February 2018
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SPRÁVA o návrhu nariadenia Európskeho parlamentu a Rady, ktorým sa mení a dopĺňa, pokiaľ ide o farmakovigilanciu humánnych liekov, nariadenie (ES) č. 726/2004, ktorým sa stanovujú postupy Spoločenstva pri povoľovaní liekov na humánne použitie a na veterinárne použitie a pri vykonávaní dozoru nad týmito liekmi a ktorým sa zriaďuje Európska agentúra pre lieky
REPORT_PLENARY · SK · 6 February 2018
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SPRÁVA o návrhu nariadenia Európskeho parlamentu a Rady, ktorým sa mení a dopĺňa, pokiaľ ide o farmakovigilanciu humánnych liekov, nariadenie (ES) č. 726/2004, ktorým sa stanovujú postupy Spoločenstva pri povoľovaní liekov na humánne použitie a na veterinárne použitie a pri vykonávaní dozoru nad týmito liekmi a ktorým sa zriaďuje Európska agentúra pre lieky
REPORT_PLENARY · SK · 6 February 2018
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Report on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
REPORT_PLENARY · EN · 30 January 2018
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Report on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
REPORT_PLENARY · EN · 30 January 2018
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Report on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
REPORT_PLENARY · EN · 30 January 2018
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Report on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
REPORT_PLENARY · EN · 30 January 2018
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Suite donnée au T7-0331/2010
ACT_FOLLOWUP · FR · 2 December 2010
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Follow up to T7-0331/2010
ACT_FOLLOWUP · EN · 17 November 2010
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2008%2F0257(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2008-0257
eu · 2008-0257 · source updated 31 December 2010