Gaois

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3 results

  1. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #647272

    IATE #3535658
    táirge íocshláinte lena úsáid ag an duine Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Déantar roinnt táirgí íocshláinte lena n-úsáid ag an duine a údarú, áfach, faoi réir an choinníll go ndéanfar faireachán breise orthu. Áirítear ina measc sin gach táirge íocshláinte lena úsáid ag an duine a bhfuil substaint ghníomhach nua ann agus táirgí íocshláinte bitheolaíochta lena n-áirítear bithshamhlacha ar tosaíochtaí iad don chógas-aireachas.' Reference "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
    Humanarzneimittel
    de
    medicinal product for human use
    en
    Definition in the framework of Directive 2001/83/EC, any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, CELEX:02001L0083-20121116/EN"
    Comment "See also:- IATE:773210 ""veterinary medicinal product; medicinal product for veterinary use"" - IATE:793544 ""medicinal product"""
    médicament à usage humain
    fr
  2. EUROPEAN UNION|EU institutions and European civil service|EU institution|European Commission · SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|committee (EU)|standing committee (EU)

    #615501

    IATE #926394
    an Buanchoiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine"
    ga
    Context 'Beidh an Buanchoiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine, arna bhunú le Treoir 2001/83/CE, de chúnamh don Choimisiún.' Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine"
    Ständiger Ausschuss für Humanarzneimittel
    de
    Standing Committee on Medicinal Products for Human Use | Committee for Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers in the Proprietary Medicinal Products Sector
    en
    Comment UPDATED: neq: 19/3/02
    comité permanent des médicaments à usage humain
    fr
  3. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|committee (EU)

    #609066

    IATE #843393
    an Coiste um Tháirgí Íocshláinte lena nÚsáid ag an Duine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ausschuss für Humanarzneimittel
    de
    Definition Teil der Agentur, zuständig für die Formulierung des Gutachtens der Agentur zu allen Fragen bezüglich der Zulässigkeit der nach dem zentralisierten Verfahren eingereichten Dossiers, der Erteilung, Änderung, Aussetzung oder des Widerrufs einer Genehmigung für das Inverkehrbringen eines Humanarzneimittels [...] sowie bezüglich der Pharmakovigilanz Reference "VO 726/2004 Gemeinschaftsverfahren für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur, Art.5 (ABl. L_136/2004, S.1) CELEX:32004R0726/DE"
    Comment DIV: RSZ 03/12/2002;UPDATED: AIH 28/05/2004; UPD: CHO 26/06/07
    Committee for Medicinal Products for Human Use | CHMP | Committee for Proprietary Medicinal Products | CPMP | Committee on Medicinal Products for Human Use
    en
    Definition Committee attached to the European Medicines Agency and responsible for drawing up the Agency's opinions on, inter alia, the granting, variation, suspension or revocation of an authorisation to place a medicinal product for human use on the market, and pharmacovigilance. Reference "Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency"
    comité des médicaments à usage humain | CHMP | CPMP | Comité des spécialités pharmaceutiques
    fr
    Definition "Comité relevant de l'Agence européenne des médicaments [IATE:843722 ], chargé de formuler l'avis de l'Agence sur, entre autres, la recevabilité, l'octroi, la modification, la suspension ou le retrait d'une autorisation de mise sur le marché d'un médicament à usage humain, ainsi que de la pharmacovigilance." Reference "CELEX:32004R0726/FR"
    CHMP
    mul