Gaois

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26 results

  1. BUSINESS AND COMPETITION|competition · INDUSTRY|industrial structures and policy|industrial policy

    #583520

    IATE #3548909
    tuarascáil maidir le hiomaíochas Eorpach Reference An Chomhairle Eorpach 14 agus 15 Márta 2013. Conclúidí (EUCO 23/13) http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/ga/ec/136155.pdf
    ga
    Context '...agus tá sí ag tnúth chomh maith leis an méid breise a chuirfidh an Coimisiún i láthair in am trátha le haghaidh an phlé sin: an tuarascáil maidir le hiomaíochas Eorpach, an tuarascáil maidir le tosaíochtaí don bheartas tionsclaíoch a chur chun feidhme...' Reference An Chomhairle Eorpach 14 agus 15 Márta 2013. Conclúidí (EUCO 23/13) http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/ga/ec/136155.pdf
    Bericht über die Wettbewerbsfähigkeit Europas | Europäischer Bericht über die Wettbewerbsfähigkeit
    de
    Definition jährlicher Bericht, der durch eine detaillierte Analyse der für die industrielle Wettbewerbsfähigkeit entscheidenden Faktoren zur Verbesserung der Wettbewerbssituation Europas beitragen soll Reference Council-DE vgl. Zusammenfassung des Berichts von 2012 http://ec.europa.eu/enterprise/policies/industrial-competitiveness/competitiveness-analysis/european-competitiveness-report/files/ecr2012_ex_sum_de.pdf (26.3.2013)
    Comment wird von der KOM seit 1995 erstellt; der vollständige Bericht liegt i.d.R. nur in EN vorDIV. aih, 26.3.2013
    European competitiveness report
    en
    Definition annual report produced to provide analytical support to the work on promoting competitiveness in the European Union Reference CENTERM, based on:Industrial competitiveness, European Competitiveness Report, DG Enterprise and Industry, http://ec.europa.eu/enterprise/policies/industrial-competitiveness/competitiveness-analysis/european-competitiveness-report/index_en.htm [6.3.2013]
    rapport sur la compétitivité européenne
    fr
    Definition publié par la Commission européenne, ce rapport annuel fournit des données empiriques permettant de mieux cerner les moteurs de la compétitivité industrielle, ainsi que les opportunités qui s'offrent aux entreprises européennes et les contraintes auxquelles elles sont confrontées Reference Conseil-FR, d'après la synthèse du rapport sur la compétitivité européenne 2012, http://ec.europa.eu/enterprise/policies/industrial-competitiveness/competitiveness-analysis/european-competitiveness-report/files/ecr2012_ex_sum_fr.pdf (14.3.2013)
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #591603

    IATE #3572784
    tuarascáil maidir le staidéar cliniciúil Reference Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:02014R0536-20140527/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition tuarascáil maidir leis an triail chliniciúil arna chur i láthair i bhformáid atá furasta le cuardach agus a ullmhaítear i gcomhréir le hIarscríbhinn I, Cuid I, Modúl 5 de Threoir 2001/83/CE agus a dhéantar a thíolacadh in iarratas ar údarú margaíochta Reference Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:02014R0536-20140527/GA
    clinical study report
    en
    Definition a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation Reference Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:02014R0536-20140527
  3. EUROPEAN UNION|European construction|European Union · LAW|rights and freedoms|rights of the individual

    #571416

    IATE #2246909
    Tuarascáil maidir leis an dul chun cinn atá déanta i ndáil le saoránacht éifeachtach AE Reference Comhairle-GA, bunaithe ar: PREASEISIÚINT an 3279ú cruinniú de chuid na Comhairle Ceartas agus Gnóthaí Baile An Bhruiséil, 5 agus 6 Nollaig 2013 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/ga/jha/140549.pdf
    ga
    Context 'An 8 Bealtaine 2013, thíolaic an Coimisiún an dara Tuarascáil ar Shaoránacht AE mar aon le tuarascáil faoi Airteagal 25 CFAE maidir leis an dul chun cinn atá déanta i ndáil le saoránacht éifeachtach AE.' Reference PREASEISIÚINT an 3279ú cruinniú de chuid na Comhairle Ceartas agus Gnóthaí Baile An Bhruiséil, 5 agus 6 Nollaig 2013 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/ga/jha/140549.pdf
    Bericht über die Unionsbürgerschaft | Bericht über die Fortschritte auf dem Weg zu einer effektiven Unionsbürgerschaft
    de
    Definition Bericht über die Anwendung der Bestimmungen des AEUV Zweiter Teil, den die KOM gemäß Art.25 AEUV alle drei Jahre erstellt Reference Council-DE vgl. Art.25 AEUV CELEX:12008E025/DE
    Comment seit 2010 Begleitdokument zu dem Bericht über die Unionsbürgerschaft gemäß IATE:3553117 DIV: aih, 30.1.2014
    Report on Citizenship of the Union | Report on progress towards effective EU citizenship
    en
    Definition report on the application of the provisions of Part Two of the Treaty on the Functioning of the European Union (TFEU), produced every three years under Article 25 TFEU (ex Article 22 TEC) Reference Council-EN based on Article 25 TFEU, CELEX:12008E025/EN
    Comment Since 2010 these reports have accompanied the "EU Citizenship Reports" [ IATE:3553117 ].
    Rapport concernant les progrès réalisés sur la voie de l'exercice effectif de la citoyenneté de l'Union | Rapport sur la citoyenneté de l’Union
    fr
    Definition rapport concernant l'application des dispositions du TFUE relatives à la non-discrimination et à la citoyenneté de l'Union Reference Conseil-FR, d'après l'article 25 du TFUE, CELEX:12008E025/FR
    Comment Publiés tous les trois ans, à partir de 2010, ces rapports accompagnent les rapports sur la citoyenneté de l’Union [ IATE:3553117 ]
  4. ECONOMICS|economic policy|economic policy

    #581051

    IATE #3541640
    Tuarascáil maidir leis an Sásra Foláirimh Reference An Chomhairle Eorpach 14 agus 15 Márta 2013. Conclúidí (EUCO 23/13) http://data.consilium.europa.eu/doc/document/ST-23-2013-INIT/ga/pdf
    ga
    Context 'Conclúidí ón gComhairle an 12 Feabhra 2013 maidir leis an Suirbhé Bliantúil Fáis agus i ndáil leis an Tuarascáil maidir leis an Sásra Foláirimh, Conclúidí ón gComhairle an 15 Feabhra 2013 maidir le hoideachas, Conclúidí ón gComhairle an 28 Feabhra 2013 i ndáil le treoir pholaitiúil maidir le fostaíocht agus beartais shóisialta...' Reference An Chomhairle Eorpach 14 agus 15 Márta 2013. Conclúidí (EUCO 23/13) http://data.consilium.europa.eu/doc/document/ST-23-2013-INIT/ga/pdf
    Warnmechanismus-Bericht | WMB
    de
    AMR | Alert Mechanism Report
    en
    Definition first step in implementing the new surveillance procedure for the prevention and correction of macroeconomic imbalances in the EU Reference Alert Mechanism Report, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0068:FIN:EN:PDF [27.2.2012]
    Comment This report also contains the final design of the scoreboard of indicators.
    RMA | rapport sur le mécanisme d’alerte
    fr
    Definition première étape de la mise en œuvre de la nouvelle procédure de surveillance pour la prévention et la correction des déséquilibres macroéconomiques [dans l'UE] Reference Rapport de la Commission sur le mécanisme d'alerte, CELEX:52012DC0068/FR
    Comment Ce rapport contient également le modèle définitif du tableau de bord d'indicateurs.
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #581240

    IATE #3542110
    tuarascáil neamhspléach thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    eigenständiger regelmäßig aktualisierter Sicherheitsbericht
    de
    stand-alone periodic safety update report | stand-alone PSUR | PSURs | reports
    en
    Definition independent periodic safety update report (PSUR) [ IATE:3535677 ] prepared for a combination of active substances authorised to one marketing authorisation holder for which separate single-substance PSURs [ IATE:3542065 ] have been provided Reference COM-EN, based on:European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [11.4.2012] and on information provided by DG SANCO [30.3.2012]
    Comment Stand-alone PSURs should be cross-referenced to the related single-substance PSURs.
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #579941

    IATE #3535677
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    regelmäßiger aktualisierter Unbedenklichkeitsbericht | PSUR | regelmäßig aktualisierter Sicherheitsbericht
    de
    PSUR | Periodic Safety Update Report
    en
    Definition update report on the worldwide safety experience of a medicinal product that must be submitted by the marketing authorisation holder to the competent authorities at defined time points after authorisation Reference COM-EN based on: European Medicines Agency. ICH Topic E 2 C (R1). Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. Step 5. Note For Guidance On Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf [28.3.2012]
    Comment A single report may cover all products containing the same active substance(s) licensed by one MA holder. The report will usually include all dosage forms and formulations, as well as all indications, associated with such an active.For combinations of substances which are also registered individually, safety information for the fixed combination may be reported either in a separate PSUR or be included as a separate presentation in the report for one of the separate components, depending on the circumstances. Cross-referencing all relevant PSURs is essential.References:MHRA (Medicines and Healthcare products Regulatory Agency) > How we regulate > Medicines > Licensing of medicines > Information for licence holders > Periodic Safety Update Reports, http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/PeriodicSafetyUpdateReports/index.htm [23.4.2012]& European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [23.4.2012]
    PSUR | rapport périodique actualisé de sécurité | rapport périodique actualisé relatif à la sécurité | rapport périodique actualisé de pharmacovigilance
    fr
    Definition document qui propose une évaluation des effets indésirables recensés par un laboratoire et qui doit être régulièrement soumis aux autorités sanitaires compétentes Reference Sénat français > Travaux parlementaires > Missions d'information > Mission commune d'information Mediator > Comptes rendus, comptes rendus de la mission commune d'information sur le Mediator, http://www.senat.fr/compte-rendu-commissions/20110523/mediator.html [8.10.2012]
    Comment L'enjeu n'est pas de savoir comment assurer le suivi en matière de pharmacovigilance, mais de faire connaître les événements indésirables qui se sont produits depuis le dernier rapport dans le cadre de l'utilisation d'un médicament.