Gaois

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6 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. 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
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #675855

    IATE #885035
    táirge íocshláinte dílleachtach Reference Comhairle-GA
    ga
    Context """Ba cheart gur de réir oibleagáidí ar leith a dhéanfaí údaruithe margaíochta den sórt sin a dheonú. Ba cheart go mbeadh sna catagóirí táirgí íocshláinte lena n-úsáid ag an duine lena mbaineann na táirgí íocshláinte, lena n-áirítear táirgí íocshláinte dílleachtacha, a bhfuil sé mar aidhm leo galair thromchúiseacha dhíblitheacha nó is baol báis a chóireáil nó a chosc...""" Reference "Rialachán (AE) 2019/5 ó Pharlaimint na hEorpa agus ón gComhairle"
    druga dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachtach lena úsáid ag an duine Reference Téarmeolaithe COM-GA
    ga
    Arzneimittel für seltene Leiden | Orphan-Arzneimittel | Humanarzneimittel für seltene Leiden
    de
    Definition ein nach den Bestimmungen der Verordnung (EG) Nr. 141/2000 ausgewiesenes Arzneimittel (Orphan medicinal product) Reference "Verordnung (EG) Nr. 141/2000, Artikel 2 Buchstabe b CELEX:32000R0141/DE"
    Comment "Gemäß der Verordnung (EG) Nr. 141/2000 sind dies nicht nur Arzneimittel für seltene Krankheiten (Kriterium: 5 Erkrankungen auf 10.000 Personen), sondern auch aus anderen Gründen nicht-rentable Arzneimittel (vgl. Artikel 3 Absatz 1 Buchstabe a).Die richtige Bezeichnung für ""Orphan disease""/""maladie orpheline"" im Deutschen lautet ""Waisenkrankheit"" oder ""Orphan-Krankheit"" (siehe IATE:139134 ). ""Seltene Krankheit"" steht dagegen für ""rare disease""/""maladie rare"" IATE:883096 ."
    orphan medicinal product | orphan medicine | orphan drug | orphan medicinal product for human use
    en
    Definition medicinal product intended for the diagnosis, prevention or treatment of a life-threatening or very serious condition, where no other such product exists because it would not be economically viable to develop one and/or because the condition is rare Reference "Council-EN based on Regulation (EC) No 141/2000 on orphan medicinal products, Article 3 CELEX:02000R0141-20190726"
    Comment "The regulatory designation as an 'orphan medicinal product' is associated with incentives intended to promote the development of such medicines.See also:- orphan disease, IATE:139134 - rare disease, IATE:883096<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>"
    médicament orphelin | médicament orphelin à usage humain
    fr
    Definition médicament destiné à traiter une maladie grave et rare, à laquelle les investisseurs s'intéressent peu Reference "Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, http://www.culture.fr/franceterme/result?francetermeSearchTerme=medicament+orphelin&francetermeSearchDomaine=0&francetermeSearchSubmit=rechercher&action=search [22.10.2018]"
    Comment "Dans le cadre juridique de l'Union européenne, un médicament orphelin est un médicament ainsi désigné dans les conditions prévues par le règlement n° 141/2000 concernant les médicaments orphelins. Conformément audit règlement, un médicament obtient la désignation de médicament orphelin si son promoteur peut établir:a) qu'il est destiné au diagnostic, à la prévention ou au traitement d'une affection entraînant une menace pour la vie ou une invalidité chronique ne touchant pas plus de cinq personnes sur dix mille dans la Communauté, au moment où la demande est introduite, ouqu'il est destiné au diagnostic, à la prévention ou au traitement, dans la Communauté, d'une maladie mettant la vie en danger, d'une maladie très invalidante ou d'une affection grave et chronique, et qu'il est peu probable que, en l'absence de mesures d'incitation, la commercialisation de ce médicament dans la Communauté génère des bénéfices suffisants pour justifier l'investissement nécessaireetb) qu'il n'existe pas de méthode satisfaisante de diagnostic, de prévention ou de traitement de cette affection ayant été autorisée dans la Communauté, ou, s'il en existe, que le médicament en question procurera un bénéfice notable à ceux atteints de cette affection.Conseil-FR, d'après le règlement n° 141/2000 concernant les médicaments orphelins, CELEX:02000R0141-20090807/FR Voir aussi:- maladie orpheline [IATE:139134 ]- maladie rare [IATE:883096 ]"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #682912

    IATE #3535566
    Comhairle Idirnáisiúnta um Chomhchuibhiú Ceanglas Teicniúil i ndáil le hEarraí Cógaisíochta atá le hÚsáid ag an Duine Reference Téarmeolaithe COM-GA
    ga
    Language usage Is gnách an t-alt a bheith roimh an ainm i.e. an Chomhairle Idirnáisiúnta um Chomhchuibhiú Ceanglas Teicniúil i ndáil le hEarraí Cógaisíochta atá le hÚsáid ag an Duine
    Context Is gá aird a thabhairt ar fhorbairtí a thagann chun cinn mar thoradh ar iarrachtaí chun bainistíocht saolré táirgí íocshláinte a ailíniú ar an leibhéal idirnáisiúnta, go háirithe i gcomhthéacs na Comhairle Idirnáisiúnta um Chomhchuibhiú Ceanglas Teicniúil i ndáil le hEarraí Cógaisíochta atá le hÚsáid ag an Duine. Reference "Rialachán Tarmligthe (AE) 2024/1701 ón gCoimisiún lena leasaítear Rialachán (CE) Uimh. 1234/2008 ón gCoimisiún a mhéid a bhaineann le scrúdú a dhéanamh ar athruithe ar théarmaí na n-údaruithe margaíochta le haghaidh táirgí íocshláinte lena n-úsáid ag an duine"
    an Chomhdháil Idirnáisiúnta um Chomhchuibhiú Ceanglas Teicniúil i ndáil le Clárú Earraí Cógaisíochta atá le hÚsáid ag an Duine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    ICH | Internationaler Rat für die Harmonisierung der technischen Anforderungen an Humanarzneimittel
    de
    International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use | International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use | ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use | International Conference on Harmonisation
    en
    Definition organisation bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration with the aim of achieving greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner Reference "COM-EN based on: ICH website http://www.ich.org/"
    Conférence internationale sur l'harmonisation des exigences techniques d'enregistrement des médicaments à usage humain | CIH | Conférence internationale sur l'harmonisation | Conférence internationale d'harmonisation
    fr
  5. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #682911

    IATE #3535560
    an Grúpa Comhordaithe d'Aitheantas Frithpháirteach agus do Nósanna Imeachta Díláraithe - don Duine Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    CMDh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Koordinierungsgruppe für das Verfahren der gegenseitigen Anerkennung und das dezentralisierte Verfahren - Humanarzneimittel
    de
    Coordination Group for Mutual Recognition and Decentralised Procedures - Human | CMDh | Co-ordination group for Mutual recognition and Decentralised procedures – human
    en
    Definition group set up under Directive 2004/27/EC for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States, in accordance with the mutual recognition procedure or the decentralised procedure Reference "Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), CELEX:32004L0027; CMDh website, http://www.hma.eu/cmdh.html [12/02/2020]"
    Comment The Group's tasks were substantially extended as of 2012 under Directive 2010/84/EU, amending Directive 2001/83/EC as regards pharmacovigilance.
    Groupe de coordination pour la procédure de reconnaissance mutuelle et la procédure décentralisée - médicaments à usage humain
    fr
  6. 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