Gaois

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6 results

  1. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #681319

    IATE #2100646
    an Coiste um Tháirgí Íocshláinte Luibhe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déanfar saineolas an Choiste um Ardteiripí (CAT), an Choiste um Tháirgí Íocshláinte Dílleachta (COMP), an Choiste Phéidiatraicigh (PDCO) agus an Choiste um Tháirgí Íocshláinte Luibhe (HMPC) a choinneáil agus a atheagrú i bhfoirm meithleacha agus díorma saineolaithe a thabharfaidh ionchur do CHMP ...' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    Committee on Herbal Medicinal Products | Committee for Herbal Medicinal Products | HMPC | Herbal Committee
    en
    Definition committee, established in 2004, composed of scientific experts from the EU Member States in the field of herbal medicinal products, to assist in the harmonisation of procedures and provisions concerning herbal medicinal products in EU Member States, and further integrate herbal medicinal products in the European regulatory framework Reference "COM-EN, based on: Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use"
  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. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #676306

    IATE #916386
    an Coiste um Tháirgí Íocshláinte Dílleachtacha Reference Téarmeolaithe COM-GA
    ga
    an Coiste um Tháirgí Íocshláinte Dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ausschuß für Arzneimittel für seltene Leiden
    de
    Comment DIV: RSZ 12/03/2003
    Committee for Orphan Medicinal Products | COMP
    en
    Definition Committee set up by Article 4 of Regulation (EC) No 141/2000 on orphan medicinal products; its tasks include examining applications for the designation of a medicinal product as an orphan medicinal product and advising the Commission on the establishment and development of a policy on orphan medicinal products for the European Union Reference "Based on Article 4, Regulation (EC) No 141/2000 on orphan medicinal products, CELEX:32000R0141"
    Comité des médicaments orphelins
    fr
    Comment institué en vertu de l’article 4 du règlement (CE) n o 141/2000
    COMP
    mul
  4. EUROPEAN UNION · SOCIAL QUESTIONS|health|pharmaceutical industry · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #675426

    IATE #844119
    an Coiste um Tháirgí Íocshláinte Tréidliachta Reference "Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle an 11 Nollaig 2018 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE"
    ga
    an Coiste um Tháirgí Íocshláinte d'Úsáid Tréidliachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ausschuss für Tierarzneimittel | CVMP
    de
    Definition einer der wissenschaftlichen Ausschüsse der Europäischen Arzneimittel-Agentur, zuständig für die Gutachten zu allen Fragen der Zulässigkeit der nach dem zentralisierten Verfahren eingereichten Dossiers sowie der Erteilung, Änderung, Aussetzung oder des Widerrufs einer Genehmigung für das Inverkehrbringen eines Tierarzneimittels Reference "VO 726/2004 Gemeinschaftsverfahren für die Genehmigung, Überwachung und Pharmakovigilanz von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur, Art.30 (ABl. L_136/2004) CELEX:32004R0726"
    Comment DIV: AIH 28/05/2004 UPD: ajs 20.9.2006
    Committee for Veterinary Medicinal Products | CVMP | Committee for Medicinal Products for Veterinary Use | Committee for Veterinary Medical Products | Committee for Medical Products for Veterinary Use
    en
    Definition "European Medicines Agency's committee responsible for veterinary medicines" Reference "European Medicines Agency > Committees > Committee for Veterinary Medicinal Products (CVMP) (3.7.2023)"
    Comment "Established by Article 139(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC."
    comité des médicaments à usage vétérinaire | CVMP | CMV
    fr
    Definition comité chargé de formuler l'avis de l'Agence européenne des médicaments sur toute question concernant la recevabilité des dossiers présentés en suivant la procédure centralisée, l'octroi, la modification, la suspension ou le retrait d'une autorisation de mise sur le marché d'un médicament vétérinaire [...] ainsi que la pharmacovigilance Reference "Règlement (CE) n° 726/2004 établissant des procédures communautaires pour l'autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments, article 30, CELEX:32004R0726/fr"
    Comment "MISC: Relève de l'Agence européenne des médicaments (IATE:843722 )."
  5. 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
  6. EUROPEAN UNION · AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health

    #681306

    IATE #1917120
    Buanchoiste um Tháirgí Íocshláinte Tréidliachta Reference "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, agus lena n-aisghairtear Rialachán (CEE) Uimh. 2377/90 ón gComhairle agus lena leasaítear Treoir 2001/82/CE ó Pharlaimint na hEorpa agus ón gComhairle agus Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32009R0470/GA"
    ga
    Language usage Is gnách an t-alt a bheith roimh an ainm i.e. Buanchoiste um Tháirgí Íocshláinte Tréidliachta
    Ständiger Ausschuss für Tierarzneimittel
    de
    Standing Committee on Veterinary Medicinal Products | Standing Committee on Medicinal Products for Veterinary Use
    en
    comité permanent des médicaments vétérinaires
    fr
    Definition comité dont la fonction est d'assister la Commission en vue de l'adaptation au progrès technique des directives visant à l'élimination des entraves techniques aux échanges dans le secteur des médicaments vétérinaires Reference "COM-FR d'après Directive 2001/82/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments vétérinaires, article 89, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0082:FR:NOT"