Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use

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Official proposal CELEX 51997PC0369 from European Union at European Commission. Dated 3 September 1997. Status: open.

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11 official files

• Vorschlag für eine Richtlinie des Europäischen Parlaments und des Rates zur Angleichung der Rechts- und Verwaltungsvorschriften über die Anwendung der Guten Klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln

  preparatory · DE · 3 September 1997

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• Proposta de directiva do Parlamento Europeu e do Conselho relativa à aproximação das disposições legislativas, regulamentares e administrativas respeitantes à aplicação da boa prática clínica na execução dos ensaios clínicos de medicamentos para uso humano

  preparatory · PT · 3 September 1997

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• Πρόταση οδηγίας του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου σχετικά με τη σύγκλιση των νομοθετικών, κανονιστικών και διοικητικών διατάξεων όσον αφορά την εφαρμογή της Ορθής Κλινικής Πρακτικής στη διεξαγωγή κλινικών δοκιμών στα φάρμακα που προορίζονται για τον άνθρωπο

  preparatory · EL · 3 September 1997

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• Propuesta de directiva del Parlamento Europeo y del Consejo relativa a la aproximación de las disposiciones legislativas, reglamentarias y administrativas sobre la aplicación de buenas prácticas clínicas en la realización de ensayos clínicos de medicamentos de uso humano

  preparatory · ES · 3 September 1997

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• Proposition de directive du parlement européen et du Conseil concernant le rapprochement des dispositions législatives, réglementaires et administratives des États membres relatives à l'application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain

  preparatory · FR · 3 September 1997

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• Proposta di direttiva del Parlamento europeo e del Consiglio concernente il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative relative all'applicazione della buona pratica clinica nell'esecuzione della sperimentazione clinica di medicinali ad uso umano

  preparatory · IT · 3 September 1997

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• Forslag til Europa-Parlamentets og Rådets direktiv om indbyrdes tilnærmelse af medlemsstaternes lovgivning og administrative bestemmelser om gennemførelse af God Klinisk Praksis (GCP) ved gennemførelse af kliniske afprøvninger af lægemidler til human brug

  preparatory · DA · 3 September 1997

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• Förslag till Europaparlamentets och rådets direktiv om tillnärmning av bestämmelser som fastställs genom lagar och andra författningar rörande tillämpning av god klinisk sed vid kliniska prövningar av humanläkemedel

  preparatory · SV · 3 September 1997

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• Ehdotus Euroopan parlamentin ja neuvoston direktiiviksi hyvän kliinisen tutkimustavan noudattamista ihmisille tarkoitettujen lääkkeiden kliinisissä tutkimuksissa koskevien lakien, asetusten ja hallinnollisten määräysten lähentämisestä

  preparatory · FI · 3 September 1997

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• Voorstel voor een richtlijn van het Europees Parlement en de Raad betreffende de onderlinge aanpassing van de wettelijke en bestuursrechtelijke bepalingen inzake de invoering van goede klinische praktijk bij de uitvoering van klinische proeven op geneesmiddelen voor gebruik bij de mens

  preparatory · NL · 3 September 1997

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• Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use

  preparatory · EN · 3 September 1997

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