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CELEX 52008PC0123

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 {SEC(2008)273} {SEC(2008)274}

openEuropean Union· European Commission· EN

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Official proposal CELEX 52008PC0123 from European Union at European Commission. Dated 4 March 2008. Status: open.

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22 official files

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 {SEC(2008)273} {SEC(2008)274}

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  • 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · EN · 4 March 2008

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  • 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · ES · 4 March 2008

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  • Návrh směrnice Evropského Parlamentu a Rady, kterou se mění směrnice 2001/82/ES a směrnice 2001/83/ES, pokud jde o změny registrací léčivých přípravků (Text s významem pro EHP) (předložená Komisí) {SEC(2008)273} {SEC(2008)274}

    preparatory · CS · 4 March 2008

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  • Priekšlikums Eiropas Parlamenta un Padomes direktīva, ar ko groza Direktīvu 2001/82/EK un Direktīvu 2001/83/EK attiecībā uz pārmaiņām zāļu tirdzniecības atļauju nosacījumos {SEC(2008)273} {SEC(2008)274}

    preparatory · LV · 4 March 2008

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  • 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · NL · 4 March 2008

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  • 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{SEC(2008)273} {SEC(2008)274}

    preparatory · DE · 4 March 2008

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  • Pasiūlymas Europos parlamento ir Tarybos direktyva iš dalies keičianti direktyvos 2001/82/EB ir direktyvos 2001/83/EB nuostatas dėl vaistų rinkodaros pažymėjimų sąlygų keitimo{SEC(2008)273} {SEC(2008)274}

    preparatory · LT · 4 March 2008

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  • Förslag 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · SV · 4 March 2008

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  • 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · IT · 4 March 2008

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  • Ettepanek: Euroopa parlamendi ja Nõukogu direktiiv, millega muudetakse direktiivi 2001/82/EÜ ja direktiivi 2001/83/EÜ seoses ravimite müügilubade tingimuste muutmisega {SEC(2008)273} {SEC(2008)274}

    preparatory · ET · 4 March 2008

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  • Propunere de directivă a Parlamentului European şi a Consiliului de modificare a Directivei 2001/82/CE şi a Directivei 2001/83/CE în ceea ce priveşte modificări ale condiţiilor autorizaţiilor de introducere pe piaţă pentru medicamente {SEC(2008)273} {SEC(2008)274}

    preparatory · RO · 4 March 2008

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  • Javaslat: az Európai parlament és a Tanács irányelve a 2001/82/EK és a 2001/83/EK irányelvnek a gyógyszerek forgalomba hozatali engedélye feltételeinek módosítása tekintetében történő módosításáról{SEC(2008)273} {SEC(2008)274}

    preparatory · HU · 4 March 2008

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  • Návrh smernica 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{SEC(2008)273} {SEC(2008)274}

    preparatory · SK · 4 March 2008

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  • Ehdotus: Euroopan parlamentin ja neuvoston direktiivi direktiivien 2001/82/EY ja 2001/83/EY muuttamisesta siltä osin kuin kyse on lääkkeiden myyntilupien ehtojen muutoksista{SEC(2008)273} {SEC(2008)274}

    preparatory · FI · 4 March 2008

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  • 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · PT · 4 March 2008

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  • Predlog direktiva 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · SL · 4 March 2008

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  • Wniosek dyrektywa Parlamentu europejskiego i Rady zmieniająca dyrektywę 2001/82/WE i dyrektywę 2001/83/WE odnośnie do zmian warunków pozwoleń na dopuszczenie do obrotu produktów leczniczych {SEC(2008)273} {SEC(2008)274}

    preparatory · PL · 4 March 2008

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  • 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 (EØS-relevant tekst){SEC(2008)273} {SEC(2008)274}

    preparatory · DA · 4 March 2008

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  • 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · FR · 4 March 2008

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  • Предложение 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 {SEC(2008)273} {SEC(2008)274}

    preparatory · BG · 4 March 2008

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  • Πρόταση οδηγία του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για την τροποποίηση της οδηγίας 2001/82/ΕΚ και της οδηγίας 2001/83/ΕΚ σχετικά με τις τροποποιήσεις των όρων της άδειας κυκλοφορίας φαρμακευτικών προϊόντων {SEC(2008)273} {SEC(2008)274}

    preparatory · EL · 4 March 2008

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  • 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 ta’ l-awtorizzazzjonijiet għat-tqegħid fis-suq ta’ prodotti mediċinali{SEC(2008)273} {SEC(2008)274}

    preparatory · MT · 4 March 2008

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