RE-EXAMINED 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 ADDITIONAL PROVISIONS FOR MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA ( COM/88/663FINAL - SYN 114 )

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Official proposal CELEX 51989PC0178 from European Union at European Commission. Dated 26 May 1989. Status: open.

Timeline

1. 26 May 1989

   Published

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9 official files

• RE-EXAMINED 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 ADDITIONAL PROVISIONS FOR MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA ( COM/88/663FINAL - SYN 114 )

  preparatory · EN · 26 May 1989

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• PROPOSTA REEXAMINADA DE DIRECTIVA DO CONSELHO QUE ALARGA O AMBITO DE APLICACAO DAS DIRECTIVAS 65/65/CEE, RELATIVAS A APROXIMACAO DAS DISPOSICOES LEGISLATIVAS, REGULAMENTARES E ADMINISTRATIVAS RESPEITANTES AS ESPECIALIDADES FARMACEUTICAS E QUE PREVE DISPOSICOES COMPLEMENTARES PARA OS PRODUTOS FARMACEUTICOS DERIVADOS DO SANGUE OU PLASMA HUMANOS ( COM/88/663FINAL - SYN 114 )

  preparatory · PT · 26 May 1989

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• GENBEHANDLET 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 SUPPLERENDE BESTEMMELSER OM LAEGEMIDLER FREMSTILLET PAA BASIS AF MENNESKEBLODSPLASMA ( KOM/88/663ENDELIG UDG. - SYN 114 )

  preparatory · DA · 26 May 1989

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• Επανεξετασθείσα 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 πρόσθετες διατάξεις για τα φαρμακευτικά προϊόντα με βάση το ανθρώπινο αίμα ή το πλάσμα ανθρωπίνου αίματος ( COM (88) 663 τελικό - SΥΝ 114 )

  preparatory · EL · 26 May 1989

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• RIESAME DELLA PROPOSTA DI DIRETTIVA DEL CONSIGLIO CHE ESTENDE IL CAMPO D' 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 AGGIUNTIVE PER I MEDICINALI DERIVANTI DA SANGUE O PLASMA UMANI

  preparatory · IT · 26 May 1989

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• OPNIEUW BEHANDELD 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 BIJKOMENDE BEPALINGEN VOOR VAN MENSELIJK BLOED OF MENSELIJK PLASMA AFGELEIDE GENEESMIDDELEN ( COM/88/663DEF - SYN 114 )

  preparatory · NL · 26 May 1989

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• PROPOSITION REEXAMINEE 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 SANG OU DU PLASMA HUMAINS ( COM/88/663FINAL - SYN 114 )

  preparatory · FR · 26 May 1989

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• UEBERPRUEFTER VORSCHLAG FUER EINE RICHTLINIE DES RATES ZUR ERWELTERUNG DES ANWENDUNGSBEREICHS DER RICHTLINIEN 65/65/EWG UND 75/319/EWG ZUR ANGLEICHUNG DER RECHTS- UND VERWALTUNGS-VORSCHRIFTEN UEBER ARZNEISPEZIALITAETEN UND ZUR FESTLEGUNG ZUSAETZILCHER VORSCHRIFTEN FUER AUS MENSCHLICHEM BLUT ODER MENSCHLICHEM BLUTPLASMA BESTEHENDE ARZNEIMITTEL ( KOM/88/663ENDG - SYN 114 )

  preparatory · DE · 26 May 1989

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• REEXAMEN DE LA PROPUESTA 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 SUPLEMENTARIAS SOBRE PRODUCTOS FARMACEUTICOS DERIVADOS DE SANGRE HUMANA ( COM/88/663FINAL - SYN 114 )

  preparatory · ES · 26 May 1989

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