Gaois

A collection of legal and legislative terms in Irish extracted from the European Union's multilingual terminology database. More information »

20 results

  1. EU policy · report · document
    Tuarascáil maidir le Costas na Neamh-Eorpa Reference ---
    ga
    Bericht über die Kosten des Verzichts auf EU-politisches Handeln
    de
    “Cost of non-Europe” study | CoNE | Cost of Non-Europe report
    en
    Definition ex-ante evaluation conducted by the European Parliamentary Research Service on the potential benefit of future EU action in policy areas where greater efficiency or a collective public good could be realised through common action at European level Reference EP-EN Terminology, based on:European Parliamentary Research Service, Impact Assessment and European Added Value, February 2018, http://www.europarl.europa.eu/EPRS/EPRS-Impact-Assessment-European-Added-Value-presentation.pdf [28.5.2018]
    rapport sur le coût de la non-Europe
    fr
    Definition rapport visant à repérer et à chercher à quantifier les bénéfices économiques potentiels significatifs de la réalisation d'un marché unique en Europe en partant du principe que l'absence d'action commune au niveau européen peut entraîner, dans un secteur donné, une perte d'efficacité de l'économie globale et/ou la non-réalisation d'un bien public collectif qui autrement pourrait exister Reference PE-FR, d’après l’étude de l’Unité Valeur ajoutée européenne, Évaluer le coût de la non-Europe 2014-2019, http://www.europarl.europa.eu/RegData/etudes/STUD/2015/536364/EPRS_STU(2015)536364_FR.pdf [20.6.2018]
  2. UN specialised agency · international agreement
    an Coinbhinsiún maidir le páirtleasú na gCoinbhinsiún arna nglacadh ag Comhdháil Ghinearálta na hEagraíochta Idirnáisiúnta Saothair ag an dá sheisiún is tríocha tosaigh ar mhaithe le caighdeánú na bhforálacha a bhaineann le hullmhú na dtuarascálacha ag Comhlacht Ceannais na Oifige Idirnáisiúnta Saothair ar chur i bhfeidhm na gCoinbhinsiún Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Übereinkommen über die teilweise Abänderung der von der Allgemeinen Konferenz der Internationalen Arbeitsorganisation auf ihren ersten zweiunddreißig Tagungen angenommenen Übereinkommen zur Vereinheitlichung der Bestimmungen betreffend die Ausarbeitung von Berichten über die Durchführung der Übereinkommen durch den Verwaltungsrat des Internationalen Arbeitsamtes
    de
    Comment CONTEXT: Kontext: Internationale Arbeitsorganisation (IAO).;MISC: Genf, 26.06.1961.
    Convention concerning the Partial Revision of the Conventions Adopted by the General Conference of the International Labour Organisation at its First Thirty-two Sessions for the Purpose of Standardising the Provisions regarding the Preparation of Reports by the Governing Body of the International Labour Office on the Working of Conventions | Final Articles Revision Convention, 1961 | ILO Convention 116
    en
    Comment Date of adoption: 26.6.1961 Date of entry into force: 5.2.1962 C 116
    Convention portant révision des articles finals, 1961 | Convention pour la révision partielle des conventions adoptées par la Conférence générale de l'Organisation internationale du travail en ses trente-deux premières sessions, en vue d'unifier les dispositions relatives à la préparation des rapports sur l'application des conventions par le conseil d'administration du Bureau international du travail
    fr
    Comment Date d'adoption: 26.6.1961Date d'entrée en vigueur: 5.2.1962C 116
  3. business organisation · social security
    an Tuarascáil maidir le Leordhóthanacht Pinsean Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Bericht zur Angemessenheit der Renten- und Pensionshöhe
    de
    Pension Adequacy Report
    en
    Definition assessment of the degree to which pensions manage to provide older people with adequate income and poverty protection Reference COM-EN, based on: European Commission Employment, Social Affairs & Inclusion, http://ec.europa.eu/social/main.jsp?catId=738&langId=en&pubId=7828&visible=0&;
    Comment Having examined the role of pensions in current living standards, the report discusses the impact of recent pension reforms, analyses the future risks to adequate old-age incomes and makes suggestions as to how these risks might be addressed by Member States, notably by women and men postponing their retirement by working to higher ages and by saving more.Reference: European Commission Employment, Social Affairs & Inclusion, http://ec.europa.eu/social/main.jsp?catId=738&langId=en&pubId=7828&visible=0&; See also: adequacy of pensions [ IATE:927282 ]
    rapport sur l’adéquation des retraites
    fr
    Definition rapport évaluant dans quelle mesure les systèmes de retraite des États membres de l'Union européenne permettent d'assurer des pensions adéquates aux retraités Reference COM-FR, d'après: 1. le livre blanc — Une stratégie pour des retraites adéquates, sûres et viables (COM/2012/55 final), CELEX:52012DC0055/FR [25.10.2017] 2. le communiqué de presse de la Commission européenne IP/2015/5769 intitulé «Pensions adéquates: un nouveau rapport demande l’adoption de mesures visant à aider les personnes à travailler jusqu’à l’âge de la retraite» (5.10.2015), http://europa.eu/rapid/press-release_IP-15-5769_fr.htm [25.10.2017]
    Comment Voir aussi: adéquation des pensions [IATE:927282 ]
  4. regional policy · social policy · deepening of the European Union
    tuarascáil ar an dul chun cinn maidir le comhtháthú eacnamaíoch agus sóisialta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    progress report on economic and social cohesion
    en
    Comment A full Cohesion report ( IATE:3507903 ) is published every three years; in the years in between, a progress report on economic and social cohesion is published.
    rapport d'étape sur la cohésion économique et sociale
    fr
  5. parliamentary proceedings · European Parliament
    tuarascáil bhliantúil maidir le gníomhaíochtaí agus faireachán Reference Rialacha Nós Imeachta Pharlaimaint na hEorpa (Iúil 2013): http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+RULES-EP+20130701+0+DOC+PDF+V0//GA&language=GA [06.08.2013]
    ga
    Context Beidh feidhm ag an gcinneadh seo maidir leis na catagóirí tuarascálacha féintionscnaimh seo a leanas: [...] Tuarascálacha Bliantúla maidir le Gníomhaíochtaí agus Faireachán (mar a liostaítear in Iarscríbhinn 1) Reference Rialacha Nós Imeachta Pharlaimaint na hEorpa (Iúil 2013): http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+RULES-EP+20130701+0+DOC+PDF+V0//GA&language=GA [06.08.2013]
    jährlicher Tätigkeits- und Überwachungsbericht
    de
    annual activity and monitoring report
    en
    rapports d'activité et rapports de suivi annuels
    fr
  6. aid policy
    Tuarascáil Chuntasachta AE maidir le Maoiniú don Fhorbairt Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    EU Accountability Report on Financing for Development
    en
    Definition annual EU report, which assesses where the EU and its member countries stand in relation to their common commitments on financing for development, especially in relation to the UN Millennium Development Goals (MDGs) [ IATE:927771 ], aid effectiveness, aid for trade, fast-start climate finance and good governance in tax matters and development Reference Council-EN, based on European Commission website (International Cooperation and Development > Policies > Financing development), https://ec.europa.eu/europeaid/policies/financing-development_en [20.5.2015]
  7. monetary relations · monetary economics · European Union
    tuarascáil maidir le cóineasú Reference An Chomhairle Eorpach, Comhairle an Aontais Eorpaigh > Beartais > Dul isteach sa limistéar euro > Cén chaoi a dtagann tír de chuid an Aontais Eorpaigh isteach sa limistéar euro, http://www.consilium.europa.eu/ga/policies/joining-euro-area/how-eu-country-joins-euro-area/ [7.7.2016]
    ga
    Context 'Gach 2 bhliain ar a laghad, scrúdaíonn Banc Ceannais Eorpach (BCE) agus an Coimisiún Eorpach na Ballstáit sin nach bhfuil sa limistéar euro ('Ballstáit a bhfuil maolú acu' mar a thugtar orthu) féachaint an gcomhlíonann siad na critéir maidir le cóineasú agus dá réir sin an bhfuil siad réidh chun an euro a ghlacadh. Eisíonn an dá cheann acu tuarascáil maidir le cóineasú ina dtíolacann siad a dtorthaí.' Reference An Chomhairle Eorpach, Comhairle an Aontais Eorpaigh > Beartais > Dul isteach sa limistéar euro > Cén chaoi a dtagann tír de chuid an Aontais Eorpaigh isteach sa limistéar euro, http://www.consilium.europa.eu/ga/policies/joining-euro-area/how-eu-country-joins-euro-area/ [7.7.2016]
    Konvergenzbericht
    de
    convergence report
    en
    Definition report issued by the European Commission and the European Central Bank every two years, or more often if a country intending to join the euro requests it, which examines whether EU Member States satisfy the conditions for adopting the single currency Reference COM-EN based on:European Commission > Economic and Financial Affairs > Economic publications > European Economy > 2012, http://ec.europa.eu/economy_finance/publications/european_economy/2012/convergence-report_en.htm [18.9.2012]
    Comment Both the ECB and the European Commission issue these reports describing the progress made by non-euro area Member States towards achieving the criteria necessary for a country to adopt the euro.
    rapport sur la convergence | rapport sur l'état de la convergence | rapport de convergence
    fr
  8. nutrition · United Nations
    Tuarascáil maidir le Cothú Domhanda Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Iarrann an Chomhairle freisin ar na Ballstáit, go háirithe orthu siúd a thug gealltanais i gComhshocrú 2013 maidir le Cothú don Fhás, leanúint de thuarascálacha rialta a ullmhú maidir lena ngealltanais airgeadais tríd an Tuarascáil Bhliantúil maidir le Cothú Domhanda' Reference Conclúidí ón gComhairle maidir leis an Dara Tuarascáil ar an Dul Chun Cinn i ndáil leis an bPlean Gníomhaíochta maidir leis an gCothú, Comhairle an Aontais Eorpaigh, http://data.consilium.europa.eu/doc/document/ST-10679-2017-INIT/ga/pdf [10.7.2017]
    Welternährungsbericht
    de
    Definition von der Welternährungsorganisation IATE:799023 jährlich herausgegebene Analyse des Ernährungszustands der Weltbevölkerung Reference Council-DE nach Council-EN
    Global Nutrition Report
    en
    Definition independent and comprehensive annual review of the state of the world’s nutrition Reference Global Nutrition Report > The Report, http://globalnutritionreport.org/the-report/ [5.9.2016]
    Comment The Global Nutrition Report convenes existing processes, highlights progress in combating malnutrition and identifies gaps and proposes ways to fill them. Through this, the Report helps to guide action, build accountability and spark increased commitment for further progress towards reducing malnutrition much faster.
    rapport mondial sur la nutrition | Rapport sur la nutrition mondiale
    fr
    Definition initiative regroupant plusieurs partenaires (gouvernements, organisations multilaréales, ONG, donateurs, entrerises), pour établir un compte rendu annuel, indépendant et exhaustif de l'état de la nutrition dans le monde Reference Conseil-FR, d'après:- site du Global Nutrition Report (en anglais) > Governance > Stakeholder Group, http://www.globalnutritionreport.org/governance/stakeholder-group/ [10.7.2017]- site de l'OMS, Accueil > Programmes et projets > Nutrition > Thèmes > Autres thèmes sur la nutrition - en anglais > Global Nutrition Report > The 2016 Global Nutrition Report > GNR summary in French, http://ebrary.ifpri.org/utils/getfile/collection/p15738coll2/id/130369/filename/130580.pdf [10.7.2017]
  9. FINANCE
    Tuarascáil maidir le hInbhuanaitheacht Fhioscach Reference '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
    Definition European Commission report examining fiscal sustainability challenges faced by Member States over the short, medium and long run Reference 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]
  10. industrial policy · competition
    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)
  11. pharmaceutical industry
    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
  12. European Union · rights of the individual
    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 Fortschritte auf dem Weg zu einer effektiven Unionsbürgerschaft | Bericht über die 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 progress towards effective EU citizenship | Report on Citizenship of the Union
    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 ]
  13. economic policy
    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.
  14. pharmaceutical industry
    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 PSUR | stand-alone periodic safety update report | 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.
  15. pharmaceutical industry
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    regelmäßig aktualisierter Sicherheitsbericht | regelmäßiger aktualisierter Unbedenklichkeitsbericht | PSUR
    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 pharmacovigilance | rapport périodique actualisé de sécurité | rapport périodique actualisé relatif à la sécurité
    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.
  16. pharmaceutical industry
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht i gcás substaint aonair Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    tuarascáil aonair thréimhsiúil chun dáta maidir le sábháilteacht Reference 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 periodic safety update report | single PSUR | single periodic safety update report | single-substance PSUR | single agent PSUR
    en
    Definition 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 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 [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
    Definition rapport périodique de sécurité [ IATE:3535677 ] établi pour des médicaments contenant la même substance active Reference 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]
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