AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE EXTENDING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS AND LAYING DOWN SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS DERIVED FROM HUMAN PLASMA

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Official proposal CELEX 51988PC0663(03) from European Union at European Commission. Dated 10 November 1988. Status: open.

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9 official files

• AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE EXTENDING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS AND LAYING DOWN SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS DERIVED FROM HUMAN PLASMA

  preparatory · EN · 10 November 1988

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• GEAENDERTER VORSCHLAG FUER EINE RICHTLINIE DES RATES ZUR ERWEITERUNG DES ANWENDUNGSBEREICHS DER RICHTLINIEN 65/65/EWG UND 75/319/EWG ZUR ANGLEICHUNG DER RECHTS- UND VERWALTUNGSVORSCHRIFTEN UEBER ARZNEISPEZIALITAETEN UND ZUR FESTLEGUNG BESONDERER VORSCHRIFTEN FUER AUS MENSCHLICHEM BLUTPLASMA BESTEHENDE ARZNEIMITTEL

  preparatory · DE · 10 November 1988

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• PROPUESTA MODIFICADA DE DIRECTIVA DEL CONSEJO POR LA QUE SE AMPLIA EL AMBITO DE LAS DIRECTIVAS 65/65/CEE Y 75/319/CEE RELATIVAS A LA APROXIMACION DE DISPOSICIONES LEGALES, REGLAMENTARIAS Y ADMINISTRATIVAS SOBRE ESPECIALIDADES FARMACEUTICAS Y POR LA QUE SE ADOPTAN DISPOSICIONES ESPECIALES SOBRE MEDICAMENTOS DERIVADOS DE PLASMA HUMANO

  preparatory · ES · 10 November 1988

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• AENDRET FORSLAG TIL RAADETS DIREKTIV OM UDVIDELSE AF ANVENDELSESOMRAADET FOR DIREKTIV 65/65/EOEF OG 75/319/EOEF OM TILNAERMELSE AF LOVGIVNING OM FARMACEUTISKE SPECIALITETER OG OM FASTSAETTELSE AF SAERLIGE BESTEMMELSER OM LAEGEMIDLER FREMSTILLET PAA BASIS AF MENNESKEBLODPLASMA

  preparatory · DA · 10 November 1988

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• GEWIJZIGD VOORSTEL VOOR EEN RICHTLIJN VAN DE RAAD TOT UITBREIDING VAN DE WERKINGSSFEER VAN DE RICHTLIJNEN 65/65/EEG EN 75/319/EEG BETREFFENDE DE AANPASSING VAN DE WETTELIJKE EN BESTUURSRECHTELIJKE BEPALINGEN INZAKE FARMACEUTISCHE SPECIALITEITEN EN TOT VASTSTELLING VAN BIJZONDERE BEPALINGEN VOOR VAN MENSELIJK PLASMA AFGELEIDE GENEESMIDDELEN

  preparatory · NL · 10 November 1988

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• Τροποποιημένη πρόταση για οδηγία του Συμβουλίου που επεκτείνει το πεδίο εφαρμογής των οδηγιών 65/65/ΕΟΚ και 75/319/ΕΟΚ για την προσέγγιση των νομοθετικών, κανονιστικών και διοικητικών διατάξεων σχετικά με τα φαρμακευτικά ιδιοσκευάσματα και θεσπίζει ειδικές διατάξεις για τα φαρμακευτικά προϊόντα, με βάση το πλάσμα ανθρωπίνου αίματος

  preparatory · EL · 10 November 1988

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• PROPOSITION MODIFIEE DE DIRECTIVE DU CONSEIL ELARGISSANT LE CHAMP D' APPLICATION DES DIRECTIVES 65/65/CEE ET 75/319/CEE CONCERNANT LE RAPPROCHEMENT DES DISPOSITIONS LEGISLATIVES, REGLEMENTAIRES ET ADMINISTRATIVES RELATIVES AUX SPECIALITES PHARMACEUTIQUES ET PREVOYANT DES DISPOSITIONS SPECIALES POUR LES MEDICAMENTS DERIVES DU PLASMA HUMAIN

  preparatory · FR · 10 November 1988

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• PROPOSTA MODIFICATA DI DIRETTIVA DEL CONSIGLIO CHE ESTENDE IL CAMPO DI APPLICAZIONE DELLE DIRETTIVE 65/65/CEE E 75/319/CEE PER IL RAVVICINAMENTO DELLE DISPOSIZIONI LEGISLATIVE, REGOLAMENTARI ED AMMINISTRATIVE RELATIVE ALLE SPECIALITA MEDICINALI E CHE FISSA DISPOSIZIONI PARTICOLARI PER I MEDICINALI DERIVATI DA PLASMA UMANO

  preparatory · IT · 10 November 1988

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• PROPOSTA ALTERADA DE DIRECTIVA DO CONSELHO QUE ALARGA O AMBITO DE APLICACAO DAS DIRECTIVAS 65/65/CEE E 75/319/CEE, RELATIVAS A APROXIMACAO DAS DISPOSICOES LEGISLATIVAS, REGULAMENTARES E ADMINISTRATIVAS RESPEITANTES AS ESPECIALIDADES FARMACEUTICAS E QUE PREVE DISPOSICOES ESPECIAIS PARA OS PRODUTOS FARMACEUTICOS DERIVADOS DO PLASMA HUMANO

  preparatory · PT · 10 November 1988

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