EUROPEAN UNION|EU institutions and European civil service|EU body · FINANCE|financial institutions and credit|financial institution
- tuarascáil maidir le freagracht chorparáideach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
29 toradh
- FINANCE
- Tuarascáil maidir le hInbhuanaitheacht Fhioscach Tagairt "'Tuarascáil maidir le hInbhuanaitheacht Fhioscach 2015,' Comhairle an Aontais Eorpaigh, http://data.consilium.europa.eu/doc/document/ST-6413-2016-INIT/ga/pdf [20.6.2017] ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
- ga
- Fiscal Sustainability Report
- en
- Sainmhíniú European Commission report examining fiscal sustainability challenges faced by Member States over the short, medium and long run Tagairt "Council-EN, based on Fiscal Sustainability Report 2015 (English only), European Commission, DG for Economic and Financial Affairs, http://ec.europa.eu/economy_finance/publications/eeip/pdf/ip018_en.pdf [3.3.2016]"
- BUSINESS AND COMPETITION|competition · INDUSTRY|industrial structures and policy|industrial policy
- tuarascáil maidir le hiomaíochas Eorpach Tagairt "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
- Comhthéacs '...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...' Tagairt "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
- Sainmhíniú jährlicher Bericht, der durch eine detaillierte Analyse der für die industrielle Wettbewerbsfähigkeit entscheidenden Faktoren zur Verbesserung der Wettbewerbssituation Europas beitragen soll Tagairt "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)"
- Nóta 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
- Sainmhíniú annual report produced to provide analytical support to the work on promoting competitiveness in the European Union Tagairt "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
- Sainmhíniú 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 Tagairt "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)"
- SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil maidir le staidéar cliniciúil Tagairt "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
- Sainmhíniú 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 Tagairt "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
- Sainmhíniú 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 Tagairt "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 (Text with EEA relevance) "
- EUROPEAN UNION|European construction|European Union · LAW|rights and freedoms|rights of the individual
- Tuarascáil maidir leis an dul chun cinn atá déanta i ndáil le saoránacht éifeachtach AE Tagairt "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
- Comhthéacs '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.' Tagairt "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
- Sainmhíniú Bericht über die Anwendung der Bestimmungen des AEUV Zweiter Teil, den die KOM gemäß Art.25 AEUV alle drei Jahre erstellt Tagairt "Council-DE vgl. Art.25 AEUV CELEX:12008E025/DE"
- Nóta "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
- Sainmhíniú 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) Tagairt "Council-EN based on Article 25 TFEU, CELEX:12008E025/EN"
- Nóta "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
- Sainmhíniú rapport concernant l'application des dispositions du TFUE relatives à la non-discrimination et à la citoyenneté de l'Union Tagairt "Conseil-FR, d'après l'article 25 du TFUE, CELEX:12008E025/FR"
- Nóta "Publiés tous les trois ans, à partir de 2010, ces rapports accompagnent les rapports sur la citoyenneté de l’Union [ IATE:3553117 ]"
- ECONOMICS|economic policy|economic policy
- Tuarascáil maidir leis an Sásra Foláirimh Tagairt "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
- Comhthéacs '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...' Tagairt "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"
- Alert Mechanism Report | AMR
- en
- Sainmhíniú first step in implementing the new surveillance procedure for the prevention and correction of macroeconomic imbalances in the EU Tagairt "Alert Mechanism Report, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0068:FIN:EN:PDF [27.2.2012]"
- Nóta This report also contains the final design of the scoreboard of indicators.
- rapport sur le mécanisme d’alerte | RMA
- fr
- Sainmhíniú 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] Tagairt "Rapport de la Commission sur le mécanisme d'alerte, CELEX:52012DC0068/FR"
- Nóta Ce rapport contient également le modèle définitif du tableau de bord d'indicateurs.
- SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil neamhspléach thréimhsiúil chun dáta maidir le sábháilteacht Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- stand-alone periodic safety update report | reports | stand-alone PSUR | PSURs
- en
- Sainmhíniú "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" Tagairt "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]"
- Nóta Stand-alone PSURs should be cross-referenced to the related single-substance PSURs.
- SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- regelmäßig aktualisierter Sicherheitsbericht | PSUR | regelmäßiger aktualisierter Unbedenklichkeitsbericht
- de
- periodic safety update report | PSUR
- en
- Sainmhíniú 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 Tagairt "COM-Terminology Coordination, 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' (5.6.2023)."
- rapport périodique actualisé de sécurité | PSUR | rapport périodique actualisé relatif à la sécurité | rapport périodique actualisé de pharmacovigilance
- fr
- Sainmhíniú document qui propose une évaluation des effets indésirables recensés par un laboratoire et qui doit être régulièrement soumis aux autorités sanitaires compétentes Tagairt "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]"
- Nóta 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.
- SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht i gcás substaint aonair Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- tuarascáil aonair thréimhsiúil chun dáta maidir le sábháilteacht Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- regelmäßig aktualisierter Sicherheitsbericht über einen einzigen Wirkstoff | Sicherheitsbericht über einen einzigen Wirkstoff
- de
- single-substance PSUR | single substance PSUR | single-substance periodic safety update report | single periodic safety update report | single PSUR | single agent PSUR
- en
- Sainmhíniú "periodic safety update report [ IATE:3535677 ] covering all products containing the same active substance [ IATE:35093 ] authorised to one marketing authorisation holder; periodic safety update report [ IATE:3535677 ] covering all products containing the same active substance [ IATE:35093 ] authorised to one marketing authorisation holder" Tagairt "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 [23.4.2012] & 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]& 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]"
- rapport périodique de sécurité unique
- fr
- Sainmhíniú "rapport périodique de sécurité [ IATE:3535677 ] établi pour des médicaments contenant la même substance active" Tagairt "TERM-FR, d'après: Conseil de l'Union européenne, Effets indésirables des médicaments: le Conseil prend des mesures, 29 novembre 2010, http://register.consilium.europa.eu/pdf/fr/10/st17/st17054.fr10.pdf [8.10.2012]"