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 {SEC(2008) 2670} {SEC(2008) 2671}

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Official proposal CELEX 52008PC0665 from European Union at European Commission. Dated 21 October 2008. Status: open.

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22 official files

• 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 {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · EN · 21 October 2008

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• 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 {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · DA · 21 October 2008

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• Förslag till Europaparlamentets och rådets direktiv om ändring, när det gäller säkerhetsövervakning av humanläkemedel, av direktiv 2001/83/EG om upprättande av gemenskapsregler för humanläkemedel {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · SV · 21 October 2008

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• Ehdotus: Euroopan parlamentin ja neuvoston direktiivi ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä annetun direktiivin 2001/83/EY muuttamisesta lääketurvatoiminnan osalta {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · FI · 21 October 2008

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• 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 relating tox médicaments à usage humain {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · FR · 21 October 2008

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• 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 {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · DE · 21 October 2008

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• Návrh smernica 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 {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · SK · 21 October 2008

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• Предложение 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 {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · BG · 21 October 2008

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• Javaslat: az Európai parlament és a Tanács irányelve az emberi felhasználásra szánt gyógyszerek közösségi kódexéről szóló 2001/83/EK európai parlamenti és tanácsi irányelvnek a farmakovigilancia tekintetében történő módosításáról {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · HU · 21 October 2008

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• 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 {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · IT · 21 October 2008

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• Wniosek dyrektywa Parlamentu europejskiego i Rady zmieniająca dyrektywę 2001/83/WE w sprawie wspólnotowego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludzi w zakresie nadzoru nad bezpieczeństwem farmakoterapii {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · PL · 21 October 2008

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• Predlog direktiva Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakoviligance {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · SL · 21 October 2008

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• Propunere de directivă a Parlamentului european şi a Consiliului de modificare, în ceea ce priveşte farmacovigilenţa, a Directivei 2001/83/CE de instituire a unui cod comunitar cu privire la medicamentele de uz uman {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · RO · 21 October 2008

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• Priekšlikums Eiropas Parlamenta un Padomes direktīva, ar ko farmakovigilances jomā groza Direktīvu 2001/83/EK par Kopienas kodeksu, kas attiecas uz cilvēkiem paredzētām zālēm {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · LV · 21 October 2008

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• 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 {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · ES · 21 October 2008

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• Πρόταση οδηγία 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 {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · EL · 21 October 2008

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• Návrh směrnice Evropského Parlamentu a Rady, kterou se mění směrnice 2001/83/ES o kodexu Společenství týkajícím se humánních léčivých přípravků, pokud jde o farmakovigilanci {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · CS · 21 October 2008

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• Pasiūlymas Europos parlamento ir Tarybos direktyva iš dalies keičianti direktyvos 2001/83/EB nuostatas dėl Bendrijos kodekso, reglamentuojančio žmonėms skirtus vaistus, nuostatas dėl farmakologinio budrumo {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · LT · 21 October 2008

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• 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 {SEG(2008) 2670} {SEG(2008) 2671}

  preparatory · MT · 21 October 2008

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• Ettepanek: Euroopa parlamendi ja Nõukogu direktiiv, millega muudetakse ravimiohutuse järelevalve osas direktiivi 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta {SEK(2008) 2670} {SEK(2008) 2671}

  preparatory · ET · 21 October 2008

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• 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 concerning geneesmiddelen voor menselijk gebruik {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · NL · 21 October 2008

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• 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 {SEC(2008) 2670} {SEC(2008) 2671}

  preparatory · PT · 21 October 2008

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