Gaois

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42 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #557853

    IATE #1443220
    táirge íocshláinte 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:32014R0536/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Aithneoidh an Ghníomhaireacht torthaí an mheasúnaithe sin ina meastóireacht ar an táirge íocshláinte lena mbaineann.' Reference Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe agus lena leasaítear Treoir 2001/83/CE agus Rialachán (CE) Uimh. 726/2004, CELEX:32007R1394/GA
    táirge cógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    cógas leighis Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Is iad acmhainní géiniteacha linn na ngéinte i speicis nádúrtha agus i speicis cheansaithe nó shaothraithe araon agus tá ról suntasach acu, agus ról atá ag méadú, i roinnt mhaith earnálacha eacnamaíocha, lena n-áirítear táirgeadh bia, foraoiseacht agus forbairt cógas leighis, cosmaidí agus foinsí bithbhunaithe fuinnimh.' Reference Rialachán (AE) Uimh. 511/2014 i ndáil le bearta comhlíonta d’úsáideoirí ó Phrótacal Nagoya maidir le Rochtain ar Acmhainní Géiniteacha agus Comhroinnt Chothrom agus Chothromasach na dTairbhí a eascraíonn as a nÚsáid san Aontas, CELEX:32014R0511/GA
    Medikament | Arzneimittel
    de
    Definition Stoff oder Stoffzusammensetzung, der/die als Mittel zur Heilung oder zur Verhütung menschlicher Krankheiten bezeichnet wird Reference Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates vom 6. November 2001 zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel, Art.1 Nr.2 CELEX:32001L0083/DE
    Comment Alle Stoffe oder Stoffzusammensetzungen, die dazu bestimmt sind, im oder am menschlichen Körper zur Erstellung einer ärztlichen Diagnose oder zur Wiederherstellung, Besserung oder Beeinflussung der menschlichen physiologischen Funktionen angewandt zu werden, gelten ebenfalls als Arzneimittel
    medicinal products | drug | medicine | pharmaceutical product | medicinal product | pharmaceutical drug | drug product | pharmaceutical
    en
    Definition any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis Reference Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 1(2) (consolidated version)
    Comment For veterinary medicinal product, see IATE:1225197 For pharmaceutical product in the broad sense used in EU legislation, see IATE:779919
    médicament
    fr
    Definition toute substance ou composition présentée comme possédant des propriétés curatives ou préventives à l'égard des maladies humaines Reference Directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relatif aux médicaments à usage humain, CELEX:32001L0083/FR [12.2.2018]
    Comment Toute substance ou composition pouvant être administrée à l'homme en vue d'établir un diagnostic médical ou de restaurer, corriger ou modifier des fonctions physiologiques chez l'homme est également considérée comme médicament. (Source: ibid.)
  2. EUROPEAN UNION|EU institutions and European civil service|EU institution|European Commission · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|committee (EU)|standing committee (EU) · SOCIAL QUESTIONS|health|pharmaceutical industry

    #542083

    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
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #540782

    IATE #916386
    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
    COMP | Committee for Orphan Medicinal Products
    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. AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal health · EUROPEAN UNION · SOCIAL QUESTIONS|health|pharmaceutical industry

    #535040

    IATE #844119
    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
    CVMP | Committee for Medicinal Products for Veterinary Use | Committee for Veterinary Medicinal Products
    en
    Definition Part of the European Medicines Agency. Responsible for drawing up the Agency's opinion on any question concerning the admissibility of files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a veterinary medicinal product on the market, and pharmacovigilance. Reference Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Article 30 CELEX:32004R0726/EN
    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 office or agency|European Medicines Agency · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|committee (EU) · SOCIAL QUESTIONS|health|pharmaceutical industry

    #534980

    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
    CPMP | Committee for Proprietary Medicinal Products | CHMP | Committee on Medicinal Products for Human Use | Committee for 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
    CPMP | comité des médicaments à usage humain | Comité des spécialités pharmaceutiques | CHMP
    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
  6. PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research · SOCIAL QUESTIONS|health|pharmaceutical industry

    #599892

    IATE #3623649
    ceist sábháilteachta i ndáil le táirge íocshláinte imscrúdaitheach Reference Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition faisnéis maidir le sábháilteacht an táirge íocshláinte imscrúdaithigh a d’fhéadfadh tionchar diúltach a bheith aige ar a chóimheas tairbhe-riosca nó lena mbaineann impleacht sláinte poibl Reference Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA
    Sicherheitsbedenken in Bezug auf ein Prüfpräparat
    de
    Definition Informationen zur Sicherheit eines Prüfpräparats mit potenziell negativen Auswirkungen auf sein Nutzen-Risiko-Verhältnis oder Folgen für die öffentliche Gesundheit Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    safety concern in relation to an investigational medicinal product
    en
    Definition information on the safety of the investigational medicinal product with potential negative impact on its benefit-risk ratio or with a public health implication Reference Commission Implementing Regulation (EU) 2022/20 laying down rules for the application of Regulation (EU) No 536/2014 as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials
  7. EUROPEAN UNION|European construction|European Union · SOCIAL QUESTIONS|health

    #526533

    IATE #125705
    Clár Comhphobail de Tháirgí Íocshláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Arzneimittelregister der Gemeinschaft
    de
    Union Register of Medicinal Products | Community Register of Medicinal Products
    en
    Definition register listing all medicinal products for human and veterinary use as well as orphan medicinal products that have received a marketing authorisation [ IATE:1589658 ] by the Commission through the centralised procedure [ IATE:3535597 ] Reference COM-CS, based on:European Commission > Live, work, travel in the EU > Public Health > Medicinal products > Medicinal products (11.3.2019)
    registre communautaire des médicaments
    fr
  8. AGRICULTURE, FORESTRY AND FISHERIES|means of agricultural production|means of agricultural production · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|intellectual property · SOCIAL QUESTIONS|health|pharmaceutical industry

    #552617

    IATE #1268236
    deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    ergänzendes Schutzzertifikat für Arzneimittel
    de
    supplementary protection certificate | SPC
    en
    Definition for medicinal products and plant protection products, certificate entering into force after expiry of a patent upon which it is based and extending the duration of the intellectual property right for maximum 5 years (5.5 years in some specific cases) Reference COM-Term Coord., based on: Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, CELEX:32009R0469/EN and Regulation (EC) No 1610/96 concerning the creation of a supplementary protection certificate for plant protection products, CELEX:31996R1610/EN
    Comment See also: - supplementary protection certificate for medicinal products (narrower) [ IATE:799937 ]- supplementary protection certificate for plant protection products (narrower) [ IATE:3533863 ] - paediatric use marketing authorisation (related) [ IATE:2243721 ]
    certificat complémentaire de protection
    fr
    Definition titre de propriété industrielle destiné aux produits pharmaceutiques et phytopharmaceutiques, permettant de prolonger la durée de protection de ces produits quand leur brevet vient à expiration Reference COM-FR, d'après règlements (CE) nº469/2009 et nº1610/96 et d'après site les-aides.fr, Certificat complémentaire de protection - médicaments ou produits pharmaceutiques, http://les-aides.fr/fiche/bJNhGWNG2e3M/inpi/certificat-complementaire-de-protection-medicaments-ou-produits-pharmaceutiques.html [12.12.2013]
    Comment Voir aussi:- IATE:799937 certificat complémentaire de protection pour les médicaments- IATE:3533863 certificat complémentaire de protection pour les produits phytopharmaceutiques.
  9. SOCIAL QUESTIONS|health|pharmaceutical industry

    #561995

    IATE #1585080
    éifeachtúlacht Reference Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás go leor trialacha cliniciúla, áfach, níl ach riosca breise íosta i gceist do shábháilteacht na ndaoine is ábhar, i gcomparáid le gnáthchleachtas cliniciúil. Is amhlaidh atá go háirithe i gcás ina bhfuil an táirge íocshláinte imscrúdaitheach cumhdaithe ag údarú margaíochta, is é sin rinneadh measúnú cheana ar an gcáilíocht, ar an tsábháilteacht agus ar an éifeachtúlacht le linn an nós imeachta um údarú margaíochta nó, mura n-úsáidtear an táirge i gcomhréir le téarmaí an údarú margaíochta, go bhfuil sé fianaise-bhunaithe agus go bhfuil sé á thacú fianaise eolaíoch foilsithe maidir le sábháilteacht agus éifeachtúlacht an táirge sin agus i gcás nach gcothaíonn an idirghabháil ach riosca breise an-teoranta don duine is ábhar gcomparáid le gnáthchleachtas 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:32014R0536/GA
    éifeachtúlacht táirge íocshláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tá sé tábhachtach do shábháilteacht na ndaoine is ábhar, sa bhreis ar theagmhais agus frithghníomhartha díobhálacha tromchúiseacha, gur cheart gach teagmhas neamhthuartha a d'fhéadfadh tionchar ábhartha a imirt ar mheasúnú sochair agus riosca ar an táirge íocshláinte nó as a leanfadh athruithe i riarachán táirge íocshláinte nó i stiúradh foriomlán trialach cliniciúla a chur i bhfógra chuig an mBallstát lena mbaineann. Áirítear ar theagmhais neamhthuartha den sórt sin méadú ar an ráta a dtarlaíonn frithghníomhartha díobhálacha tromchúiseacha tuartha a bhféadfadh tábhacht chliniciúil a bheith ag baint leo, guais shuntasach ar an bpobal othar, amhail easpa éifeachtúlachta táirge íocshláinte nó mórfhionnachtana sábháilteachta ó staidéar ar ainmhithe a tugadh chun críche le deireanas (amhail carcanaigineacht).' 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:32014R0536/GA
    éifeachtacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Wirkung | Wirksamkeit
    de
    efficacy of a medicinal product | efficacy
    en
    Definition measurement of a medicine's desired effect under ideal conditions, such as in a clinical trial Reference European Medicines Agency (EMA). Glossary > Efficacy (13.11.2020)
    efficacité
    fr
  10. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product · SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #599898

    IATE #3623656
    Foclóir Táirgí Íocshláinte an Aontais Eorpaigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    EU-Arzneimittelverzeichnis
    de
    EU Medicinal Product Dictionary | Article 57 database | Article 57 EU product database | xEVMPD | Extended EudraVigilance Medicinal Product Dictionary
    en
    Definition extended version of the EVMPD medicinal product dictionary fed by marketing authorisation holders with product-related data on all medicinal products authorised in the European Economic Area, including product names, the authorisation holder and relevant pharmacovigilance system, the type and status of the authorisation, pharmaceutical formulation and strength, and the route of administration, as well as active ingredients and excipients Reference COM-EN and COM-Terminology Coordination, based on: Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use’ COM(2013) 472 final — 2013/0222 (COD)
  11. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · SOCIAL QUESTIONS|health|health policy|organisation of health care|public health

    #596880

    IATE #3589291
    grúpa stiúrtha feidhmiúcháin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Maidir le táirgí íocshláinte, ba cheart grúpa stiúrtha feidhmiúcháin a bhunú laistigh den Ghníomhaireacht chun freagairt láidir ar mhórimeachtaí a áirithiú agus chun gníomhaíochtaí práinneacha laistigh den Aontas a chomhordú maidir leis na saincheisteanna a bhaineann le soláthar táirgí íocshláinte a bhainistiú. Ba cheart don Ghrúpa Stiúrtha liostaí de tháirgí íocshláinte criticiúla a bhunú chun faireachán ar na táirgí sin a áirithiú agus ba cheart dó a bheith in ann comhairle a sholáthar maidir leis an ngníomhaíocht is gá a dhéanamh chun cáilíocht, sábháilteacht, agus éifeachtúlacht táirgí íocshláinte a choimirciú agus chun ardleibhéal cosanta do shláinte an duine a áirithiú.' Reference Togra le haghaidh Rialachán maidir le ról treisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis, CELEX:52020PC0725/GA
    Grúpa Stiúrtha Leigheasra Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Grúpa Stiúrtha Feidhmiúcháin um Ghanntanais Táirgí Leighis agus um Shábháilteacht Táirgí Leighis Reference Togra le haghaidh Rialachán maidir le ról treisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis, CELEX:52020PC0725/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Grúpa Stiúrtha Feidhmiúcháin um Ghanntanais agus Sábháilteacht Táirgí Íocshláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ba cheart don Ghrúpa Stiúrtha Feidhmiúcháin um Ghanntanais agus Sábháilteacht Táirgí Íocshláinte tairbhiú de thaithí fhairsing eolaíochta na Gníomhaireachta maidir le meastóireacht agus maoirseacht ar tháirgí íocshláinte agus ba cheart dó ról ceannasach na Gníomhaireachta i ndáil le comhordú agus tacaíocht don fhreagairt ar ghanntanais le linn phaindéim COVID‑19 a fhorbairt a thuilleadh.' Reference Togra le haghaidh Rialachán maidir le ról treisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis, CELEX:52020PC0725/GA
    hochrangige Lenkungsgruppe | hochrangige Lenkungsgruppe der EU zur Überwachung möglicher Engpässe bei Arzneimitteln aufgrund von Großereignissen | Hochrangige Lenkungsgruppe zur Überwachung möglicher Engpässe bei Arzneimitteln und zur Sicherheit von Arzneimitteln | Lenkungsgruppe für Arzneimittel
    de
    Definition von der Kommission gemeinsam mit den Mitgliedstaaten und der Europäischen Arzneimittel-Agentur eingesetztes Gremium mit der Aufgabe, mögliche Engpässe bei Arzneimitteln aufgrund von COVID-19 zu überwachen Reference MITTEILUNG DER KOMMISSION AN DAS EUROPÄISCHE PARLAMENT, DEN EUROPÄISCHEN RAT, DEN RAT, DIE EUROPÄISCHE ZENTRALBANK, DIE EUROPÄISCHE INVESTITIONSBANK UND DIE EURO-GRUPPE Die koordinierte wirtschaftliche Reaktion auf die COVID-19-Pandemie
    executive steering group | Medicines Steering Group | Executive Steering Group on Shortages and Safety of Medicinal Products | MSSG | Medicine Shortages Steering Group | EU Executive Steering Group on shortages of medicines caused by major events | Executive Steering Group on Shortages and Safety of Medicines
    en
    Definition group set up by the European Medicines Agency, the European Commission and national competent authorities in the EU Member States, to monitor potential shortages of medicines caused by major events Reference COM-Terminology Coordination, based on:Communication - Coordinated economic response to the COVID-19 Outbreak, COM/2020/112 finalEuropean Medicines Agency > News & events > News and press releases > 10/03/2020 > Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU (12.5.2021)
    groupe de pilotage exécutif | groupe de pilotage exécutif de l’Union sur les pénuries de médicaments causées par des événements majeurs | groupe de pilotage exécutif sur les pénuries et l’innocuité des médicaments
    fr
    Definition groupe mis sur pied par la Commission européenne avec l’Agence européenne des médicaments et les États membres dans le but de suivre l’évolution d’éventuelles pénuries de médicaments entraînées par la pandémie de COVID-19 Reference COM-FR, d'après:COMMUNICATION DE LA COMMISSION Réaction économique coordonnée à la flambée de COVID-19 (COM/2020/112 final)
    Comment Dans le contexte du nouveau coronavirus, ce comité de pilotage, présidé par la Commission européenne, doit définir et coordonner les actions européennes de protection des patients face au risque de ruptures de stock de médicaments, par exemple lorsque des sites de fabrication sont temporairement fermés ou lorsque des matières premières ou finies ne peuvent être exportées. Ce comité est également chargé d'assurer une information complète et transparente aussi bien des patients que des professionnels de santé.
  12. AGRICULTURE, FORESTRY AND FISHERIES|means of agricultural production|means of agricultural production · EUROPEAN UNION|European Union law|EU act · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|intellectual property · SOCIAL QUESTIONS|health|pharmaceutical industry

    #590429

    IATE #3570854
    Rialachán (CE) Uimh. 469/2009 maidir leis an deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte Reference Rialachán (CE) Uimh. 469/2009 maidir leis an deimhniú forlíontach cosanta le haghaidh táirgí íocshláinte, CELEX:32009R0469/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    an Rialachán maidir le deimhnithe forlíontacha cosanta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    ESZ-Verordnung | Verordnung (EG) Nr. 469/2009 über das ergänzende Schutzzertifikat für Arzneimittel
    de
    Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products | SPC Regulation | Regulation on Supplementary Protection Certificates
    en
    Comment Entry into force: 6.7.2009
    règlement relatif au certificat complémentaire de protection | règlement CCP | règlement (CE) n° 469/2009 concernant le certificat complémentaire de protection pour les médicaments
    fr
  13. SOCIAL QUESTIONS|health|pharmaceutical industry

    #599156

    IATE #3599399
    substaint ghníomhach fhalsaithe a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Maidir le gníomhaithe tríú páirtí atá bainteach le dea-chleachtas dáileachán do shubstaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta, ba cheart do na gníomhaithe sin cloí le ranna ábhartha an dea-chleachtais dáileacháin do shubstaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta agus ba cheart ranna ábhartha an dea-chleachtais a bheith mar chuid dá n-oibleagáidí conarthacha. Ní mór do na comhpháirtithe uile sa slabhra soláthair cur chuige comhsheasmhach a chleachtadh ionas go mbeidh rath ar an gcomhrac i gcoinne substaintí gníomhacha falsaithe a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta.' Reference Rialachán Cur Chun Feidhme (AE) 2021/1280 maidir le bearta i ndáil le dea-chleachtas dáileacháin do shubstaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R1280/GA
    substaint ghníomhach fhalsaithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition aon substaint ghníomhach a úsáidtear mar ábhar tosaigh i dtáirgí íocshláinte tréidliachta a bhfuil léiriú bréagach ann ar aon cheann díobh seo a leanas: (i) an sainaitheantas a bhaineann léi, lena n-áirítear an phacáistíocht agus an lipéadú, an t-ainm atá uirthi nó an comhdhéanamh maidir le haon cheann de na comhábhair agus neart na gcomhábhar thar a chéile; (ii) foinse na substainte, lena n-áirítear an monaróir, tír a monaraíochta, tír a tionscnaimh; nó (iii) stair na substainte, lena n-áirítear na taifid agus na doiciméid a bhaineann leis na bealaí dáileacháin a úsáideadh Reference Rialachán Cur Chun Feidhme (AE) 2021/1280 maidir le bearta i ndáil le dea-chleachtas dáileacháin do shubstaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R1280/GA
    falsified active substance used as a starting material in veterinary medicinal products
    en
    Definition active substance used as a starting material in veterinary medicinal products with a false representation of any of the following: (i) its identity, including its packaging and labelling, its name or its components as regards any of the ingredients and the strength of those ingredients;(ii) its source, including its manufacturer, its country of manufacturing, its country of origin; or(iii) its history, including the records and documents relating to the distribution channels used. Reference Commission Implementing Regulation (EU) 2021/1280 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6
  14. SCIENCE|natural and applied sciences|life sciences · SOCIAL QUESTIONS|health|pharmaceutical industry

    #570053

    IATE #2228848
    táirge íocshláinte ardteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Arzneimittel für neuartige Therapien
    de
    Definition die folgenden Humanarzneimittel:- Gentherapeutika gemäß Anhang I Teil IV der Richtlinie 2001/83/EG,- somatische Zelltherapeutika gemäß Anhang I Teil IV der Richtlinie 2001/83/EG,- biotechnologisch bearbeitete Gewebeprodukte gemäß Buchstabe b Reference Verordnung (EG) Nr. 1394/2007 über Arzneimittel für neuartige Therapien CELEX:32007R1394/DE (17.2.2009)
    advanced therapy medicinal product
    en
    Definition any of the following medicinal products for human use:?- a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC, or- a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,or- ?a tissue engineered product as defined in point (b) of Article 2(1) of Regulation (EC) No 1394/2007 Reference Regulation (EC) No 1394/2007 on advanced therapy medicinal products, Article 2(1)(a), CELEX:02007R1394-20120702/EN
    produit de thérapie innovante | médicament de thérapie innovante
    fr
    Comment notion plus restreinte que celle de produit de thérapie innovante [ IATE:2228511 ]
  15. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #544330

    IATE #1073980
    táirge íocshláinte bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Biologika | Biologikum | biologisches Arzneimittel | Biopharmakon
    de
    Definition Arzneimittel, dessen Wirkstoff ein biologischer Stoff ist Reference Richtlinie 2003/63/EG der Kommissionzur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel
    biopharmaceutical | biomedicine | biologic | biological medicinal product
    en
    Definition product, the active substance of which is a biological substance Reference CELEX:32003L0063/EN Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
    médicament biologique | biomédicament
    fr
    Definition produit dont la substance active est une substance biologique Reference Directive 2003/63/CE de la Commission, CELEX:32003L0063/fr
  16. SOCIAL QUESTIONS|health|pharmaceutical industry

    #529769

    IATE #766172
    cógas cineálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ba cheart bearta iomchuí a ghlacadh d'fhonn a áirithiú go dtarlóidh idirthuras rianúil cógas cineálach.' Reference Rialachán (AE) 2015/2424 lena leasaítear Rialachán (CE) Uimh. 207/2009 ón gComhairle maidir leis an trádmharc Comhphobail agus Rialachán (CE) Uimh. 2868/95 ón gCoimisiún lena gcuirtear chun feidhme Rialachán (CE) Uimh. 40/94 ón gComhairle maidir leis an trádmharc Comhphobail, agus lena naisghairtear Rialachán (CE) Uimh. 2869/95 ón gCoimisiún maidir leis na táillí iníoctha leis an Oifig um Chomhoiriúnú sa Mhargadh Inmheánach (Trádmharcanna agus Dearaí), CELEX:32015R2424/GA
    táirge íocshláinte cineálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Nachahmerpräparat | Generikum | generisches Arzneimittel
    de
    Definition zulassungspflichtiges pharmazeutisches Produkt oder Fertigarzneimittel, dessen Wirkstoff dem eines originalen Fertigarzneimittels identisch ist und das nicht unter einem eingetragenen Warenzeichen, sondern unter seinem international empfohlenen Freinamen (generic name) im Handel ist Reference Hunnius, Pharmazeutisches Wörterbuch, 7. Aufl.; Roche Lexikon Medizin,4. Aufl., Stichw. "Generika"
    Comment ANT: Originalpräparat IATE:766937 ; UPD: hm, 3.10.2006
    generic | generics | generic drug | generic medicine | non-proprietary medicinal product | generic medicinal product | generic pharmaceutical product | generic pharmaceutical | generic medicament
    en
    Definition off-patent medicinal product [ IATE:3550057 ] marketed under a non-proprietary name Reference Council-EN See also the definition of 'generic medicinal product' in Article 10(2) of Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:02001L0083-20121116/EN
    Comment A generic product has the same qualitative and quantitative composition in active substances [ IATE:35093 ] as the reference medicinal product [ IATE:3541634 ], with different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance being considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. A generic product also has the same pharmaceutical form [ IATE:1106950 ] as the reference medicinal product, the various immediate-release oral pharmaceutical forms being considered to be one and the same pharmaceutical form. The bioequivalence [ IATE:1090485 ] of the generic product with the reference medicinal product must have been demonstrated by appropriate bioavailability studies [ IATE:3518727 ]. COM-Terminology Coordination, based on:Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:02001L0083-20121116/EN
    médicament générique | générique | produit pharmaceutique générique
    fr
    Definition Un médicament générique est un médicament similaire à un médicament qui a déjà été autorisé (le« médicament de référence »). Un médicament générique contient la même quantité de principe(s) actif(s) que le médicament de référence. Le médicament générique et le médicament de référence sont utilisés à la même dose pour traiter la même affection et présentent un degré de sécurité et d'efficacité équivalent. (...) Reference EMEA (European Medicines Agency) http://www.ema.europa.eu/pdfs/human/pcwp/EMEA-2007-0440-00-00-ENFR.pdf (9.4.2010)
    Comment Voir aussi la définition figurant dans la directive 2004/27/CE du Parlement européen et du Conseil modifiant la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain CELEX:32004L0027/fr
  18. SOCIAL QUESTIONS|health|pharmaceutical industry

    #582128

    IATE #3543176
    táirge íocshláinte cúntach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Hilfspräparat
    de
    auxiliary medicinal product | auxiliary medicinal products
    en
    Definition medicinal product used in the context of a clinical trial, but not as an investigational medicinal product 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:32014R0536/EN
    Comment Auxiliary medicinal products do not include concomitant medications, i.e. medications unrelated to the clinical trial and not relevant for the design of the clinical trial.
    médicament auxiliaire
    fr
    Definition médicament utilisé dans le contexte d'un essai clinique, mais non comme médicament expérimental Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  19. SOCIAL QUESTIONS|health · SOCIAL QUESTIONS|health|pharmaceutical industry

    #538592

    IATE #885035
    druga dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachtach Reference Comhairle-GA
    ga
    Context "Ba cheart gur de réir oibleagáidí ar leith a dhéanfaí údaruithe margaíochta den sórt sin a dheonú. Ba cheart go mbeadh sna catagóirí táirgí íocshláinte lena n-úsáid ag an duine lena mbaineann na táirgí íocshláinte, lena n-áirítear táirgí íocshláinte dílleachtacha, a bhfuil sé mar aidhm leo galair thromchúiseacha dhíblitheacha nó is baol báis a chóireáil nó a chosc..." Reference Rialachán (AE) 2019/5 ó Pharlaimint na hEorpa agus ón gComhairle
    Arzneimittel für seltene Leiden | Orphan-Arzneimittel
    de
    Definition ein nach den Bestimmungen der Verordnung (EG) Nr. 141/2000 ausgewiesenes Arzneimittel (Orphan medicinal product) Reference Verordnung (EG) Nr. 141/2000, Artikel 2 Buchstabe b CELEX:32000R0141/DE
    Comment Gemäß der Verordnung (EG) Nr. 141/2000 sind dies nicht nur Arzneimittel für seltene Krankheiten (Kriterium: 5 Erkrankungen auf 10.000 Personen), sondern auch aus anderen Gründen nicht-rentable Arzneimittel (vgl. Artikel 3 Absatz 1 Buchstabe a).Die richtige Bezeichnung für "Orphan disease"/"maladie orpheline" im Deutschen lautet "Waisenkrankheit" oder "Orphan-Krankheit" (siehe IATE:139134 ). "Seltene Krankheit" steht dagegen für "rare disease"/"maladie rare" IATE:883096 .
    orphan medicine | orphan medicinal product | orphan drug
    en
    Definition medicinal product intended for the diagnosis, prevention or treatment of a life-threatening or very serious condition, where no other such product exists because it would not be economically viable to develop one and/or because the condition is rare Reference Council-EN based on Regulation (EC) No 141/2000 on orphan medicinal products, Article 3 CELEX:02000R0141-20190726
    Comment The regulatory designation as an 'orphan medicinal product' is associated with incentives intended to promote the development of such medicines.See also:- orphan disease, IATE:139134 - rare disease, IATE:883096<><><><><><><><><><><><><><>
    médicament orphelin
    fr
    Definition médicament destiné à traiter une maladie grave et rare, à laquelle les investisseurs s'intéressent peu Reference Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, http://www.culture.fr/franceterme/result?francetermeSearchTerme=medicament+orphelin&francetermeSearchDomaine=0&francetermeSearchSubmit=rechercher&action=search [22.10.2018]
    Comment Dans le cadre juridique de l'Union européenne, un médicament orphelin est un médicament ainsi désigné dans les conditions prévues par le règlement n° 141/2000 concernant les médicaments orphelins. Conformément audit règlement, un médicament obtient la désignation de médicament orphelin si son promoteur peut établir:a) qu'il est destiné au diagnostic, à la prévention ou au traitement d'une affection entraînant une menace pour la vie ou une invalidité chronique ne touchant pas plus de cinq personnes sur dix mille dans la Communauté, au moment où la demande est introduite, ouqu'il est destiné au diagnostic, à la prévention ou au traitement, dans la Communauté, d'une maladie mettant la vie en danger, d'une maladie très invalidante ou d'une affection grave et chronique, et qu'il est peu probable que, en l'absence de mesures d'incitation, la commercialisation de ce médicament dans la Communauté génère des bénéfices suffisants pour justifier l'investissement nécessaireetb) qu'il n'existe pas de méthode satisfaisante de diagnostic, de prévention ou de traitement de cette affection ayant été autorisée dans la Communauté, ou, s'il en existe, que le médicament en question procurera un bénéfice notable à ceux atteints de cette affection.Conseil-FR, d'après le règlement n° 141/2000 concernant les médicaments orphelins, CELEX:02000R0141-20090807/FR Voir aussi:- maladie orpheline [IATE:139134 ]- maladie rare [IATE:883096 ]
  20. SOCIAL QUESTIONS|health|pharmaceutical industry

    #584712

    IATE #3552427
    táirge íocshláinte faoi bhun caighdeáin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    minderwertiges Arzneimittel
    de
    Definition Produkt, dessen Zusammensetzung und Bestandteile nicht den korrekten wissenschaftlichen Spezifikationen entsprechen und das dadurch unwirksam und häufig auch gefährlich für den Patienten ist Reference WHO zitiert nach EAASM (European Alliance for Access to Safe Medicines), http://www.eaasm.eu/counterfeit-medicines,de (6.10.2014)
    substandard medicine | substandard medicines | substandard medicinal product
    en
    Definition pharmaceutical product [ IATE:1443220 ] that does not meet the quality standards and specifications Reference WHO. SIXTY-FOURTH WORLD HEALTH ASSEMBLY. Provisional agenda item 13.7. Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, http://apps.who.int/gb/ssffc/pdf_files/A64_16-en.pdf [4.12.2013]
    Comment Each pharmaceutical product that a manufacturer produces has to comply with quality assurance standards and specifications, at release and throughout its shelf-life, according to the requirements of the territory of use. Normally, these standards and specifications are reviewed, assessed and approved by the applicable national or regional medicines regulatory authority before the product is authorized for marketing.
    médicament de qualité inférieure | produit médical de qualité inférieure
    fr
    Definition médicaments ne répondant pas aux normes de sécurité, d’efficacité et de qualité en vigueur Reference COM-FR, d'après Décision WHA63(10) de l’OMS relative aux «Produits médicaux de qualité inférieure/faux/faussement étiquetés/falsifiés/contrefaits», 63e Assemblée mondiale de la santé, avril 2010, http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_DIV3-fr.pdf [12.8.2014]
    Comment Voir aussi: médicament [IATE:1443220 ]