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]"
BUSINESS AND COMPETITION|competition · INDUSTRY|industrial structures and policy|industrial policy
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"
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"
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 (Text with EEA relevance) "
EUROPEAN UNION|European construction|European Union · LAW|rights and freedoms|rights of the individual
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"
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"
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 ]."
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 ]"
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"
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.
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.
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-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)."
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.
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]"