Variations to the terms of marketing authorisations for medicinal products

votedEuropean Union· European Parliament· EN

Introduced

13 March 2008

Last action

30 June 2009 · 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
Изменения на условията за разрешителни за пускане на пазара на лекарствени продукти
Czech
Změny podmínek registrace léčivých přípravků
Danish
Ændringer af betingelserne i markedsføringstilladelser for lægemidler
German
Änderungen der Bedingungen für Zulassungen von Arzneimitteln
Greek
Τροποποιήσεις των όρων της άδειας κυκλοφορίας φαρμακευτικών προϊόντων
Spanish
Modificación de los términos de la autorización para comercializar medicamentos
Estonian
Ravimite müügilubade tingimuste muutmine
Finnish
Lääkkeiden myyntilupien ehtojen muutokset
French
Modifications des termes d’une autorisation de mise sur le marché de médicaments
Hungarian
A gyógyszerek forgalomba hozatali engedélye feltételeinek módosítása
Italian
Variazioni dei termini delle autorizzazioni all'immissione in commercio dei medicinali
Lithuanian
Vaistų rinkodaros pažymėjimų sąlygų keitimas
Latvian
Zāļu tirdzniecības atļauju nosacījumu grozīšana
Maltese
Varjazzjonijiet għall-kundizzjonijiet ta' l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali
Dutch
Wijzigingen in de voorwaarden van vergunningen voor het in de handel brengen van geneesmiddelen
Polish
Zmiany warunków pozwoleń na dopuszczenie do obrotu produktów leczniczych
Portuguese
Alteração dos termos das autorizações de introdução no mercado de medicamentos
Romanian
Modificări ale condițiilor autorizațiilor de introducere pe piață pentru medicamente
Slovak
Zmeny podmienok povolení na uvedenie na trh pre lieky
Slovenian
Spremembe pogojev dovoljenj za promet z zdravili
Swedish
Ändringar av villkoren för godkännanden för försäljning av läkemedel

Records

Official bill 2008/0045(COD) from European Union at European Parliament. Dated 13 March 2008. Status: PLENARY_VOTE.

Timeline

13 March 2008
Introduced
Variations to the terms of marketing authorisations for medicinal products
Source: COD
13 March 2008
referral
Source: REFERRAL
22 October 2008
plenary amend proposal
Source: PLENARY_AMEND_PROPOSAL
22 October 2008
Vote results
Source: PLENARY_VOTE_RESULTS
18 June 2009
signature
Source: SIGNATURE
30 June 2009
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

No vote records are attached yet.

Versions

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Documents

68 official files

Report on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products

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Report on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products
REPORT_PLENARY · EN · 18 November 2020
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Report on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products
REPORT_PLENARY · EN · 18 November 2020
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BETÄNKANDE om förslaget till Europaparlamentets och rådets direktiv om ändring av direktiv 2001/82/EG och direktiv 2001/83/EG när det gäller ändringar av villkoren för godkännanden för försäljning av läkemedel
REPORT_PLENARY · SV · 1 November 2019
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BETÄNKANDE om förslaget till Europaparlamentets och rådets direktiv om ändring av direktiv 2001/82/EG och direktiv 2001/83/EG när det gäller ändringar av villkoren för godkännanden för försäljning av läkemedel
REPORT_PLENARY · SV · 1 November 2019
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RAPORT referitor la propunerea de directivă a Parlamentului European și a Consiliului de modificare a Directivei 2001/82/CE și a Directivei 2001/83/CE în ceea ce privește modificări ale condițiilor autorizațiilor de introducere pe piață pentru medicamente
REPORT_PLENARY · RO · 1 November 2019
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RAPORT referitor la propunerea de directivă a Parlamentului European și a Consiliului de modificare a Directivei 2001/82/CE și a Directivei 2001/83/CE în ceea ce privește modificări ale condițiilor autorizațiilor de introducere pe piață pentru medicamente
REPORT_PLENARY · RO · 1 November 2019
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SPRÁVA o návrhu smernice Európskeho parlamentu a Rady, ktorou sa menia a dopĺňajú smernica 2001/82/ES a smernica 2001/83/ES, pokiaľ ide o zmeny podmienok povolení na uvedenie na trh pre lieky
REPORT_PLENARY · SK · 1 November 2019
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SPRÁVA o návrhu smernice Európskeho parlamentu a Rady, ktorou sa menia a dopĺňajú smernica 2001/82/ES a smernica 2001/83/ES, pokiaľ ide o zmeny podmienok povolení na uvedenie na trh pre lieky
REPORT_PLENARY · SK · 1 November 2019
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POROČILO o predlogu Direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/82/ES in Direktive 2001/83/ES v zvezi s spremembami pogojev dovoljenj za promet z zdravili
REPORT_PLENARY · SL · 1 November 2019
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POROČILO o predlogu Direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/82/ES in Direktive 2001/83/ES v zvezi s spremembami pogojev dovoljenj za promet z zdravili
REPORT_PLENARY · SL · 1 November 2019
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VERSLAG over het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging van Richtlijn 2001/82/EG en Richtlijn 2001/83/EG, wat wijzigingen in de voorwaarden van vergunningen voor het in de handel brengen van geneesmiddelen betreft
REPORT_PLENARY · NL · 1 November 2019
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VERSLAG over het voorstel voor een richtlijn van het Europees Parlement en de Raad tot wijziging van Richtlijn 2001/82/EG en Richtlijn 2001/83/EG, wat wijzigingen in de voorwaarden van vergunningen voor het in de handel brengen van geneesmiddelen betreft
REPORT_PLENARY · NL · 1 November 2019
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RELATÓRIO sobre a proposta de directiva do Parlamento Europeu e do Conselho que altera a Directiva 2001/82/CE e a Directiva 2001/83/CE no que diz respeito à alteração dos termos das autorizações de introdução no mercado de medicamentos
REPORT_PLENARY · PT · 1 November 2019
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RELATÓRIO sobre a proposta de directiva do Parlamento Europeu e do Conselho que altera a Directiva 2001/82/CE e a Directiva 2001/83/CE no que diz respeito à alteração dos termos das autorizações de introdução no mercado de medicamentos
REPORT_PLENARY · PT · 1 November 2019
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SPRAWOZDANIE w sprawie wniosku dotyczącego dyrektywy Parlamentu Europejskiego i Rady zmieniającej dyrektywę 2001/82/WE i dyrektywę 2001/83/WE odnośnie do zmian warunków pozwoleń na dopuszczenie do obrotu produktów leczniczych
REPORT_PLENARY · PL · 1 November 2019
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SPRAWOZDANIE w sprawie wniosku dotyczącego dyrektywy Parlamentu Europejskiego i Rady zmieniającej dyrektywę 2001/82/WE i dyrektywę 2001/83/WE odnośnie do zmian warunków pozwoleń na dopuszczenie do obrotu produktów leczniczych
REPORT_PLENARY · PL · 1 November 2019
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda d-Direttiva 2001/82/KE u d-Direttiva 2001/83/KE fir-rigward tal-varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta’ prodotti mediċinali
REPORT_PLENARY · MT · 1 November 2019
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda d-Direttiva 2001/82/KE u d-Direttiva 2001/83/KE fir-rigward tal-varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta’ prodotti mediċinali
REPORT_PLENARY · MT · 1 November 2019
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica le direttive 2001/82/CE e 2001/83/CE per quanto concerne le variazioni dei termini delle autorizzazioni all'immissione in commercio dei medicinali
REPORT_PLENARY · IT · 1 November 2019
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica le direttive 2001/82/CE e 2001/83/CE per quanto concerne le variazioni dei termini delle autorizzazioni all'immissione in commercio dei medicinali
REPORT_PLENARY · IT · 1 November 2019
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai, ar ko groza Direktīvu 2001/82/EK un Direktīvu 2001/83/EK attiecībā uz pārmaiņām zāļu tirdzniecības atļauju nosacījumos
REPORT_PLENARY · LV · 1 November 2019
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ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes direktīvai, ar ko groza Direktīvu 2001/82/EK un Direktīvu 2001/83/EK attiecībā uz pārmaiņām zāļu tirdzniecības atļauju nosacījumos
REPORT_PLENARY · LV · 1 November 2019
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PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos, iš dalies keičiančios Direktyvos 2001/82/EB ir Direktyvos 2001/83/EB nuostatas dėl vaistų rinkodaros pažymėjimų sąlygų keitimo
REPORT_PLENARY · LT · 1 November 2019
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PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos direktyvos, iš dalies keičiančios Direktyvos 2001/82/EB ir Direktyvos 2001/83/EB nuostatas dėl vaistų rinkodaros pažymėjimų sąlygų keitimo
REPORT_PLENARY · LT · 1 November 2019
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi direktiivien 2001/82/EY ja 2001/83/EY muuttamisesta siltä osin kuin kyse on lääkkeiden myyntilupien ehtojen muutoksista
REPORT_PLENARY · FI · 1 November 2019
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi direktiivien 2001/82/EY ja 2001/83/EY muuttamisesta siltä osin kuin kyse on lääkkeiden myyntilupien ehtojen muutoksista
REPORT_PLENARY · FI · 1 November 2019
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JELENTÉS a 2001/82/EK és a 2001/83/EK irányelvnek a gyógyszerek forgalomba hozatali engedélye feltételeinek módosítása tekintetében történő módosításáról szóló európai parlamenti és tanácsi irányelvre irányuló javaslatról
REPORT_PLENARY · HU · 1 November 2019
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JELENTÉS a 2001/82/EK és a 2001/83/EK irányelvnek a gyógyszerek forgalomba hozatali engedélye feltételeinek módosítása tekintetében történő módosításáról szóló európai parlamenti és tanácsi irányelvre irányuló javaslatról
REPORT_PLENARY · HU · 1 November 2019
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RAPPORT sur la proposition de directive du Parlement européen et du Conseil modifiant la directive 2001/82/CE et la directive 2001/83/CE en ce qui concerne les modifications des termes d'une autorisation de mise sur le marché de médicaments
REPORT_PLENARY · FR · 1 November 2019
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RAPPORT sur la proposition de directive du Parlement européen et du Conseil modifiant la directive 2001/82/CE et la directive 2001/83/CE en ce qui concerne les modifications des termes d'une autorisation de mise sur le marché de médicaments
REPORT_PLENARY · FR · 1 November 2019
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse direktiivi 2001/82/EÜ ja direktiivi 2001/83/EÜ seoses ravimite müügilubade tingimuste muutmisega
REPORT_PLENARY · ET · 1 November 2019
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RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse direktiivi 2001/82/EÜ ja direktiivi 2001/83/EÜ seoses ravimite müügilubade tingimuste muutmisega
REPORT_PLENARY · ET · 1 November 2019
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INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo por la que se modifican la Directiva 2001/82/CE y la Directiva 2001/83/CE en lo relativo a las variaciones de los términos de las autorizaciones de comercialización de medicamentos
REPORT_PLENARY · ES · 1 November 2019
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INFORME sobre la propuesta de Directiva del Parlamento Europeo y del Consejo por la que se modifican la Directiva 2001/82/CE y la Directiva 2001/83/CE en lo relativo a las variaciones de los términos de las autorizaciones de comercialización de medicamentos
REPORT_PLENARY · ES · 1 November 2019
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου που αφορά την τροποποίηση της οδηγίας 2001/82/ΕΚ και της οδηγίας 2001/83/ΕΚ σχετικά με τις τροποποιήσεις των όρων της άδειας κυκλοφορίας φαρμακευτικών προϊόντων
REPORT_PLENARY · EL · 1 November 2019
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ΕΚΘΕΣΗ σχετικά με την πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου που αφορά την τροποποίηση της οδηγίας 2001/82/ΕΚ και της οδηγίας 2001/83/ΕΚ σχετικά με τις τροποποιήσεις των όρων της άδειας κυκλοφορίας φαρμακευτικών προϊόντων
REPORT_PLENARY · EL · 1 November 2019
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ДОКЛАД относно предложението за директива на Европейския парламент и на Съвета за изменение на Директиви 2001/82/EО и 2001/83/EО относно измененията на условията за разрешителни за пускане на пазара на лекарствени продукти
REPORT_PLENARY · BG · 1 November 2019
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ДОКЛАД относно предложението за директива на Европейския парламент и на Съвета за изменение на Директиви 2001/82/EО и 2001/83/EО относно измененията на условията за разрешителни за пускане на пазара на лекарствени продукти
REPORT_PLENARY · BG · 1 November 2019
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BERICHT über den Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/82/EG und der Richtlinie 2001/83/EG in Bezug auf Änderungen der Bedingungen für Zulassungen von Arzneimitteln
REPORT_PLENARY · DE · 1 November 2019
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BERICHT über den Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/82/EG und der Richtlinie 2001/83/EG in Bezug auf Änderungen der Bedingungen für Zulassungen von Arzneimitteln
REPORT_PLENARY · DE · 1 November 2019
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ZPRÁVA o návrhu směrnice Evropského parlamentu a Rady, kterou se mění směrnice 2001/82/ES a směrnice 2001/83/ES, pokud jde o změny registrací léčivých přípravků
REPORT_PLENARY · CS · 1 November 2019
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ZPRÁVA o návrhu směrnice Evropského parlamentu a Rady, kterou se mění směrnice 2001/82/ES a směrnice 2001/83/ES, pokud jde o změny registrací léčivých přípravků
REPORT_PLENARY · CS · 1 November 2019
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets direktiv om ændring af direktiv 2001/82/EF og direktiv 2001/83/EF for så vidt angår ændringer af betingelserne i markedsføringstilladelser for lægemidler
REPORT_PLENARY · DA · 1 November 2019
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BETÆNKNING om forslag til Europa-Parlamentets og Rådets direktiv om ændring af direktiv 2001/82/EF og direktiv 2001/83/EF for så vidt angår ændringer af betingelserne i markedsføringstilladelser for lægemidler
REPORT_PLENARY · DA · 1 November 2019
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Suite donnée au T6-0510/2008
ACT_FOLLOWUP · FR · 3 February 2009
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Follow up to T6-0510/2008
ACT_FOLLOWUP · EN · 3 February 2009
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MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston direktiiviksi direktiivien 2001/82/EY ja 2001/83/EY muuttamisesta siltä osin kuin kyse on lääkkeiden myyntilupien ehtojen muutoksista
REPORT_PLENARY · FI · 15 September 2008
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RAPPORT dwar il-proposta għal direttiva tal-Parlament Ewropew u tal-Kunsill li temenda d-Direttiva 2001/82/KE u d-Direttiva 2001/83/KE fir-rigward tal-varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta’ prodotti mediċinali
REPORT_PLENARY · MT · 15 September 2008
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RELAZIONE sulla proposta di direttiva del Parlamento europeo e del Consiglio che modifica le direttive 2001/82/CE e 2001/83/CE per quanto concerne le variazioni dei termini delle autorizzazioni all'immissione in commercio dei medicinali
REPORT_PLENARY · IT · 15 September 2008
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JELENTÉS a 2001/82/EK és a 2001/83/EK irányelvnek a gyógyszerek forgalomba hozatali engedélye feltételeinek módosítása tekintetében történő módosításáról szóló európai parlamenti és tanácsi irányelvre irányuló javaslatról
REPORT_PLENARY · HU · 15 September 2008
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2008%2F0045(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2008-0045
eu · 2008-0045 · source updated 30 June 2009