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 ADDITIONAL PROVISIONS FOR IMMUNOLOGICAL MEDICINAL PRODUCTS CONSISTING OF VACCINES, TOXINS OR SERUMS AND ALLERGENS

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Official proposal CELEX 51988PC0663(02) 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 ADDITIONAL PROVISIONS FOR IMMUNOLOGICAL MEDICINAL PRODUCTS CONSISTING OF VACCINES, TOXINS OR SERUMS AND ALLERGENS

  preparatory · EN · 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 WETTELIJKE EN BESTUURSRECHTELIJKE BEPALINGEN INZAKE FARMACEUTISCHE SPECIALITEITEN EN TOT INVOERING VAN BIJKOMENDE BEPALINGEN VOOR IMMUNOLOGISCHE GENEESMIDDELEN BESTAANDE UIT VACCINS, TOXINEN OF SERUMS EN ALLERGENEN

  preparatory · NL · 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 LAS DISPOSICIONES LEGALES, REGLAMENTARIAS Y ADMINISTRATIVAS SOBRE ESPECIALIDADES FARMACEUTICAS Y POR LA QUE SE ADOPTAN DISPOSICIONES SUPLEMENTARIAS SOBRE MEDICAMENTOS IMMUNOLOGICOS CONSISTENTES EN VACUNAS, TOXINAS, SUEROS Y ALERGENOS

  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 YDERLIGERE BESTEMMELSER FOR IMMUNOLOGISKE LAEGEMIDLER I FORM AF VACCINER, TOKSINER, SERA OG ALLERGENER

  preparatory · DA · 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 πρόσθετες διατάξεις για τα ανοσολογικά φαρμακευτικά προϊόντα, που συνίστανται σε εμβόλια, τοξίνες ή ορρούς και αλλεργιογόνα

  preparatory · EL · 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 ZUSAETZLICHER VORSCHRIFTEN FUER AUS IMPFSTOFFEN, TOXINEN ODER SEREN UND ALLERGENEN BESTEHENDE IMMUNOLOGISCHE ARZNEIMITTEL

  preparatory · DE · 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 CONCERNENTI IL RAVVICINAMENTO DELLE DISPOSIZIONI LEGISLATIVE, REGOLAMENTARI ED AMMINISTRATIVE RELATIVE ALLE SPECIALITA MEDICINALI E CHE PREVEDE NORME AGGIUNTIVE PER I MEDICINALI IMMUNOLOGICI COSTITUITI DA VACCINI, TOSSINE O SIERI E ALLERGENI

  preparatory · IT · 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 COMPLEMENTAIRES POUR LES MEDICAMENTS IMMUNOLOGIQUES CONSISTANT EN VACCINS, TOXINES, SERUMS OU ALLERGENES

  preparatory · FR · 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 OU ADMINISTRATIVAS RESPEITANTES AS ESPECIALIDADES FARMACEUTICAS E QUE ESTABELECEM DISPOSICOES COMPLEMENTARES PARA OS PRODUTOS FARMACEUTICOS IMUNOLOGICOS QUE CONSISTAM EM VACINAS, TOXINAS OU SOROS E ALERGENEOS

  preparatory · PT · 10 November 1988

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