Gaois

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67 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #628616

    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"
    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"
    táirge cógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Arzneimittel | Medikament
    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 product | medicine | pharmaceutical | drug | drug product | pharmaceutical drug | pharmaceutical product
    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. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648655

    IATE #3543169
    táirge íocshláinte imscrúdaitheach ardteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfpräparat für neuartige Therapien
    de
    Definition Prüfpräparat, das ein Arzneimittel für neuartige Therapien im Sinne des Artikels 2 Absatz 1 der Verordnung (EG) Nr. 1394/2007 des Europäischen Parlaments und des Rates ist Reference COM-Internes Dokument SANCO-2012-80155-02-01
    advanced therapy investigational medicinal product
    en
    Definition "advanced therapy medicinal product [ IATE:2228848 ] which is also an investigational medicinal product [ IATE:2146586 ]" Reference "COM-EN, based on:Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:52012PC0369/EN"
    médicament expérimental de thérapie innovante
    fr
    Definition "médicament expérimental correspondant à un médicament de thérapie innovante [ IATE:2228848 ]" Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  3. SOCIAL QUESTIONS|health|pharmaceutical industry · SCIENCE|natural and applied sciences|life sciences

    #639313

    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 | ATMP
    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)"
    médicament de thérapie innovante | produit de thérapie innovante | MTI
    fr
    Comment "notion plus restreinte que celle de produit de thérapie innovante [ IATE:2228511 ]"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #608757

    IATE #834434
    oibreán frithmhiocróbach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ciallaíonn “frithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha” cumas miocrorgánach teacht slán nó fás áit a bhfuil tiúchan oibreán frithmhiocróbach ar gnách gur leor é chun miocrorgánaigh den speiceas céanna a chosc nó a mharú...' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    antimikrobielles Mittel | Antimikrobenmittel | antimikrobieller Stoff | mikrobenabweisender Stoff | Stoff mit antimikrobieller Wirkung | antimikrobiell wirkender Stoff | antimikrobieller Wirkstoff
    de
    Definition synthetisch oder auf natürlichem Wege durch Bakterien, Pilze oder Pflanzen erzeugte Biozide, die zur Abtötung von Mikroorganismen - Bakterien, Viren, Pilze und Parasiten, insbesondere Protozoen - oder zur Hemmung ihres Wachstums eingesetzt werden Reference "Empfehlung zur umsichtigen Verwendung antimikrobieller Mittel in der Humanmedizin, Erw.1 (ABl. L_34/2002, S.13) CELEX:32002H0077/DE"
    Comment "umfasst neben Antibiotika IATE:1098823 , Virustatika, Antimykotika, Antiparasitika aber auch Desinfektionsmittel; XREF: Antibiotikum IATE:1098823 ; Antibiotika-Resistenz IATE:1073649 ; Antimikrobielle Resistenz IATE:912591 ; DIV: RSZ, 7.10.09"
    antimicrobial | antimicrobial medicine | antimicrobial medicinal product | antimicrobial substance | antimicrobial agent | antimicrobial drug
    en
    Definition any naturally occurring, semi-synthetic or synthetic substance that exhibits antimicrobial activity (kills or inhibits the growth of micro-organisms) and/or the final medicinal product containing such an active substance Reference "Directive 2005/25/EC amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms"
    Comment "Includes antibiotics, antivirals, antifungals, anticoccidials and antiprotozoals."
    agent antimicrobien | agent anti-microbien | antimicrobien | médicament antimicrobien | substance antimicrobienne
    fr
    Definition toute substance produite de manière synthétique ou naturelle par des bactéries, des champignons ou des plantes, utilisée pour détruire ou empêcher la croissance de micro-organismes tels que les bactéries, les virus et les champignons, ainsi que des parasites, en particulier les protozoaires Reference "Communication de la Commission sur une stratégie communautaire de lutte contre la résistance antimicrobienne CELEX:52001DC0333/FR"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648660

    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
  6. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #617731

    IATE #1073980
    táirge íocshláinte bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biologisches Arzneimittel | Biologikum | Biologika | 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"
    biological medicinal product | biologic | biomedicine | biopharmaceutical
    en
    Definition "product, the active substance of which is a biological substance" Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Comment medicinal product, the active substance of which is produced by or extracted from a biological source and which due to its complexity, its characterisation and the determination of its quality may require a combination of physico-chemical-biological testing, together with its control strategy
    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"
  7. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #651265

    IATE #3552431
    táirge íocshláinte tréidliachta bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... tá difríochtaí ann a bhaineann le hamhábhair nó idir próisis mhonaraíochta an táirge íocshláinte tréidliachta bhitheolaíoch agus an táirge íocshláinte tréidliachta bhitheolaíoch tagartha.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Definition táirge íocshláinte tréidliachta inar substaint bhitheolaíoch í an tsubstaint ghníomhach Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    biological veterinary medicinal product | veterinary biological medicinal product
    en
    Definition "veterinary medicinal product where an active substance is a biological substance" Reference "Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC "
  8. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product

    #640916

    IATE #2250149
    leigheas bithchosúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biosimilar medicinal product | biosimilar | similar biological medicinal product | similar biological | biosimilar medicine | biogeneric
    en
    Definition biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’) Reference "COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products"
    Comment Unlike the small molecules of classical medicines, which are ‘chemically’ synthesised, the much more complex biosimilars are extracted or synthesised from biological sources such as blood or tissues, and for this reason cannot be fully identical to their reference products.
    biosimilaire | biogénérique | médicament biologique similaire
    fr
  10. SOCIAL QUESTIONS|health|pharmaceutical industry

    #651286

    IATE #3552473
    comhtháirge íocshláinte tréidliachta Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Tierarzneimittel aus kombinierten Wirkstoffen
    de
    combination veterinary medicinal product
    en
    Definition "veterinary medicinal product containing active substances used in the composition of authorised veterinary medicinal products" Reference "Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)"
    Comment "See also:- combined vaccine"
    association médicamenteuse | synergie médicamenteuse
    fr
    Definition regroupement de plusieurs principes actifs dans un même médicament vétérinaire ou association de plusieurs médicaments vétérinaires permettant d'augmenter l'efficacité et de diminuer les doses, donc les risques d'effets indésirables de chacun d'entre eux Reference COM-FR, d’après Le Larousse médical (édition 2006) > association médicamenteuse [14.8.2014]
    Comment "Lorsque le contexte ne permet pas de le déduire, on pourra éventuellement préciser «à usage vétérinaire» (COM-FR).À ne pas confondre avec l’interaction médicamenteuse [IATE:1073736 ], qui peut être positive ou négative, voulue ou fortuite.Source: Le Larousse médical (édition 2006) > interaction médicamenteuse [14.8.2014]"
  11. SOCIAL QUESTIONS|health|pharmaceutical industry

    #641405

    IATE #3501747
    comhtháirge íocshláinte ardteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    combined advanced therapy medicinal product | combined ATMP | combination ATMP
    en
    Definition "advanced therapy medicinal product that fulfils the following conditions: – it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and – its cellular or tissue part must contain viable cells or tissues, or – its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to" Reference "Regulation (EC) No 1394/2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004"
    médicament combiné de thérapie innovante
    fr
    Definition médicament de thérapie innovante qui satisfait aux conditions suivantes:- il doit incorporer comme partie intégrante un ou plusieurs dispositifs médicaux au sens de l’article 1er, paragraphe 2, point a), de la directive 93/42/CEE, ou bien un ou plusieurs dispositifs médicaux implantables actifs au sens de l’article 1er, paragraphe 2, point c), de la directive 90/385/CEE, et- sa partie cellulaire ou tissulaire doit contenir des cellules ou des tissus viables, ou- sa partie cellulaire ou tissulaire contenant des cellules ou des tissus non viables doit être susceptible d’avoir sur le corps humain une action qui peut être considérée comme essentielle par rapport à celle des dispositifs précités Reference "CELEX:32007R1394/fr"
  12. SOCIAL QUESTIONS|health|pharmaceutical industry · 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)

    #609066

    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
    Committee for Medicinal Products for Human Use | CHMP | Committee for Proprietary Medicinal Products | CPMP | Committee on 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"
    comité des médicaments à usage humain | CHMP | CPMP | Comité des spécialités pharmaceutiques
    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
  13. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #614197

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

    #609130

    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
    Committee for Veterinary Medicinal Products | CVMP | Committee for Medicinal Products for Veterinary Use | Committee for Veterinary Medical Products | Committee for Medical Products for Veterinary Use
    en
    Definition "European Medicines Agency's committee responsible for veterinary medicines" Reference "European Medicines Agency > Committees > Committee for Veterinary Medicinal Products (CVMP) (3.7.2023)"
    Comment "Established by Article 139(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC."
    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 )."
  15. SOCIAL QUESTIONS|health · INTERNATIONAL ORGANISATIONS|world organisations

    #654309

    IATE #3566119
    cógas góchumtha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Níl dabht ar bith ann ach go bhfuil méadú ag teacht ar an líon daoine atá ag ceannach cógas ar líne agus cógas góchumtha agus gur saincheist é seo nach mór do ghníomhaireachtaí rialála ar fud na hEorpa aird a thabhairt air.' Reference "'Tuarascáil Bhliantúil 2007 - Ag Cosaint Sláinte Poiblí agus Ainmhí', an tÚdarás Rialála Táirgí Sláinte, https://www.hpra.ie/docs/default-source/publications-forms/corporate-policy-documents/turarsc%C3%A1il-bhliant%C3%BAil-2007-imb.pdf?sfvrsn=2 [3.2.2016]"
    Arzneimittelfälschung
    de
    counterfeit medicinal product | counterfeit medicine
    en
    Definition "medicine1 which is deliberately and fraudulently mislabelled with respect to identity and/or source1medicine [ IATE:1443220 ]" Reference "World Health Organisation > International Medical Products Anti-Counterfeiting Taskforce (IMPACT) > Frequently Asked Questions, http://www.who.int/impact/impact_q-a/en/index.html [4.8.2015] > 5) What are counterfeit medicines?"
    Comment "1. WHO's definition is closer to the EU definition of falsified medicine1 than to EU definition of counterfeit medicine2.2. At the present moment, there is considerable ambiguity between the terms 'falsified medicine' and 'counterfeit medicine'. The suggestion has been made that the World Health Organization/International Medical Products Anti-Counterfeiting Taskforce (WHO/IMPACT) definition could be changed to refer to ‘falsified’ rather than ‘counterfeit’ medicines. If that change were made, then the meaning of ‘counterfeit’ medicines would revert to that referred to in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) - a wilful form of trademark infringement. A possible solution suggested is to exclude trademark issues from the definition of falsification used by WHO, recognising that these are adequately covered by the TRIPS definition of counterfeiting, and that civil trademark infringement is not relevant.1falsified medicine [ IATE:3500876 ]2counterfeit [ IATE:3566118 ]References:1. COM-Terminology Coordination2. Charles Clift, Senior Research Consultant; 'Meeting Summary - Counterfeit, Falsified and Substandard Medicines', Centre on Global Health Security, December 2010 http://www.chathamhouse.org/sites/files/chathamhouse/field/field_document/161210summary.pdf [1.9.2015]"
    médicament contrefait | médicament de contrefaçon | médicaments contrefaçons produit pharmaceutique médical produits pharmaceutiques médicaux
    fr
    Definition médicament qui est délibérément et frauduleusement muni d’une étiquette n'indiquant pas son identité et/ou sa source véritable Reference "Site de l'OMS, ""Médicaments contrefaits - Guide pour l'élaboration de mesures visant à éliminer les médicaments contrefaits"", 2000, http://apps.who.int/medicinedocs/fr/d/Jwhozip41f/2.1.html [9.3.2011]"
    Comment "Il peut s'agir d'une spécialité ou d'un produit générique, et parmi les produits contrefaits, il en est qui contiennent les bons ingrédients ou de mauvais ingrédients, ou bien encore pas de principe actif et il en est d'autres où le principe actif est en quantité insuffisante ou dont le conditionnement a été falsifié.(Source: ibid.)La définition que l’OMS donne de médicament contrefait se rapproche davantage de la notion de médicament faslifié, définie dans la directive 2011/62/UE modifiant la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain, en ce qui concerne la prévention de l’introduction dans la chaîne d’approvisionnement légale de médicaments falsifiés, que de celle de médicament contrefait telle que définie par l’UE.Voir aussi:médicament falsifié [ IATE:3500876 ]médicament contrefait [ IATE:3566119 ]"
  16. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament

    #664300

    IATE #3591678
    táirge íocshláinte criticiúil Reference "RIALACHÁN (AE) 2022/123 Ó PHARLAIMINT NA hEORPA AGUS ÓN gCOMHAIRLE an 25 Eanáir 2022 maidir le ról atreisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis (9.2.2024)"
    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 (an “Grúpa Stiúrtha maidir le Ganntanais Cógas – MSSG”) a bhainistiú. Le MSSG, ba cheart liostaí de tháirgí íocshláinte criticiúla a bhunú chun faireachán ar na táirgí sin a áirithiú agus ba cheart dó a bheith in ann comhairle agus moltaí a sholáthar maidir leis an ngníomhaíocht is gá a dhéanamh chun cáilíocht, sábháilteacht agus éifeachtúlacht táirgí íocshláinte, mar aon le soláthar táirgí íocshláinte a choimirciú agus chun ardleibhéal cosanta do shláinte an duine a áirithiú. Reference "RIALACHÁN (AE) 2022/123 Ó PHARLAIMINT NA hEORPA AGUS ÓN gCOMHAIRLE an 25 Eanáir 2022 maidir le ról atreisithe don Ghníomhaireacht Leigheasra Eorpach in ullmhacht agus bainistiú géarchéimeanna do tháirgí íocshláinte agus d’fheistí leighis (9.2.2024)"
    cógas leighis criticiúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'De bharr phaindéim COVID‑19, d’aithin an Chomhairle gur tosaíocht freisin iad comhordú a dhéanamh ar bheartais sláinte an Aontais, bainistiú géarchéime a neartú agus táirgeadh táirgí íocshláinte agus feistí leighis riachtanacha san Aontas a mhéadú. Ina theannta sin, d’iarr roinnt Ballstát go ndéanfaí comhordú lena áirithiú go mbeidh cógais leighis chriticiúla ar fáil, lena n‑áirítear vacsaíní agus feistí leighis i rith ghéarchéim COVID‑19 agus le haghaidh géarchéimeanna sláinte féideartha sa todhchaí.' 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"
    cógas criticiúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    kritisches Arzneimittel
    de
    critical medicinal product | critical medicine
    en
    Definition medicinal product that is essential to ensure the continuity of care and the provision of quality healthcare, and to guarantee a high level of public health protection in Europe, and whose unavailability results in serious harm or risk of serious harm to patients Reference COM-Terminology Coordination, based on: COM-Internal document: SG-2023-03297 (medicine shortages)
  17. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648659

    IATE #3543175
    táirge íocshláinte imscrúdaitheach diagnóiseach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    diagnostisches Prüfpräparat
    de
    diagnostic investigational medicinal product
    en
    Definition "investigational medicinal product [ IATE:2146586 ] used to make a medical diagnosis" Reference COM-EN, based on: COM-Internal document: SANCO-2012-80155-00-01 Regulation on clinical trials on medicinal products for human use
    médicament expérimental de diagnostic
    fr
    Definition médicament expérimental utilisé pour réaliser un diagnostic Reference COM-FR, d'après:COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  18. SOCIAL QUESTIONS|health|pharmaceutical industry

    #631909

    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
    Wirksamkeit | Wirkung
    de
    efficacy | efficacy of a medicinal product
    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
  19. SOCIAL QUESTIONS|health|pharmaceutical industry

    #651737

    IATE #3555276
    táirgí atá cosúil go bunúsach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    essentially similar product | essentially similar medicinal product
    en
    Definition "medicinal product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent with the original product, unless it is apparent in the light of scientific knowledge that it differs from it as regards safety and efficacy" Reference "COM-Terminology Coordination, based on: European Medicines Agency. Committee for Proprietary Medicinal Products (CPMP). 'Note for Guidance on the Investigation of Bioavailability and Bioequivalence' (7.6.2023). London, 14 December 2000"
  20. EUROPEAN UNION|EU institutions and European civil service|EU office or agency · SOCIAL QUESTIONS|health|pharmaceutical industry

    #609098

    IATE #843722
    an Ghníomhaireacht Leigheasra Eorpach Reference Togra le haghaidh Rialacháin ón gComhairle lena leasaítear Rialachán (CE) Uimh. 297/95 maidir le táillí is iníoctha leis an nGníomhaireacht Leigheasra Eorpach mar aon le nóta faisnéise míniúcháin. COM (2005) 106.
    ga
    EMA Reference "https://europa.eu/european-union/about-eu/agencies/ema_ga"
    ga
    Context Déanann an Ghníomhaireacht Leigheasra Eorpach (EMA) sláinte an duine agus sláinte ainmhithe a chosaint agus a chur chun cinn trí mheastóireacht agus monatóireacht a dhéanamh ar leigheasanna laistigh den Aontas Eorpach (AE) agus den Limistéar Eorpach Eacnamaíoch (LEE). Reference "https://europa.eu/european-union/about-eu/agencies/ema_ga"
    gníomhaireacht measúnú táirge íochshláinte, GLE
    ga
    EMEA Reference "Interinstitutional Style Guide 9.5.3 (a) on unique abbreviations for all linguistic versions. http://publications.europa.eu/code/en/en-390500.htm09/09/2009 ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Europäische Arzneimittel-Agentur | Agentur Beurteilung Arzneimitteln | EMA | EMEA | Europäische Agentur für die Beurteilung von Arzneimitteln
    de
    Definition dezentrale Einrichtung der Europäischen Union für die Beurteilung und Überwachung von Human- und Tierarzneimitteln Reference "Europ. Kommission http://europa.eu/agencies/community_agencies/emea/index_de.htm"
    European Medicines Evaluation Agency | European Medicines Agency | European Agency for the Evaluation of Medicinal Products | EMA | EAMA | EMEA
    en
    Definition agency, established by Regulation (EEC) No 2309/93 of 22 July 1993 and renamed by Regulation (EC) No 726/2004, which is responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products Reference "COM-EN, based on:- Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, CELEX:31993R2309/EN - Regulation (EC) No 726/2004 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, CELEX:32004R0726/EN"
    Agence européenne des médicaments | médicament pour l'évaluation | EMA | EMEA | AEM AEEM | Agence européenne pour l'évaluation des médicaments
    fr
    Definition agence de l'UE chargée de coordonner les ressources scientifiques existantes mises à sa disposition par les États membres en vue de l'évaluation, de la surveillance et de la pharmacovigilance des médicaments Reference "Règlement (CE) no 726/2004 du Parlement européen et du Conseil du 31 mars 2004 établissant des procédures de l'Union 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 (Texte présentant de l'intérêt pour l'EEE)Texte présentant de l'intérêt pour l'EEE"