Gaois

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7 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · TRADE|tariff policy|customs regulations

    #531115

    IATE #779919
    táirge cógaisíochta Reference Comhad na hEorpa 17/87, lch. 7 ;Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tá gá le deighilt praghsanna a bheith ann idir margaí i dtíortha forbartha agus margaí sna tíortha is boichte atá i mbéal forbartha chun a áirithiú go ndéantar táirgí cógaisíochta bunriachtanacha a sholáthar do na tíortha is boichte atá i mbéal forbartha ar phraghsanna atá laghdaithe go mór.' Reference Rialachán (AE) 2016/793 chun sraonadh trádála príomhchógas áirithe isteach san Aontas Eorpach a sheachaint, CELEX:32016R0793/GA
    pharmazeutisches Erzeugnis | Medikament | Arzneimittel
    de
    Definition jedes Erzeugnis des pharmazeutischen Sektors Reference Verordnung 816/2006 über Zwangslizenzen für Patente an der Herstellung von pharmazeutischen Erzeugnissen für die Ausfuhr in Länder mit Problemen im Bereich der öffentlichen Gesundheit, Art.2 Nr.1 CELEX:32006R0816/DE
    pharmaceutical product
    en
    Definition any product of the pharmaceutical sector Reference Council-EN, based i.a. on Regulation (EC) No 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, Article 2 CELEX:32006R0816/EN and the Annex to the TRIPS Agreement, WTO General Council Decision of 6 December 2005, Amendment of the TRIPS Agreement http://www.wto.org/english/tratop_E/trips_e/wtl641_e.htm [23.6.2015]
    Comment The definition here reflects the very broad concept adopted in EU legislation, which includes a much wider range of products than drugs or medicines [ IATE:1443220 ]: see for instance Chapter 30 ('Pharmaceutical products') of the Combined Nomenclature [ IATE:766773 ] - p. 254 et seq. of the PDF: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:312:FULL&from=EN .For a discussion of the concepts, see also the judgment in case C-360/11 [ CELEX:62011CJ0360/EN ].
    produit pharmaceutique
    fr
  2. 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.)
  3. INTERNATIONAL RELATIONS|international affairs|international agreement · SOCIAL QUESTIONS|health|pharmaceutical industry

    #536557

    IATE #853536
    PIC Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Coinbhinsiún maidir le hIniúchtaí Cógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    PIC | Übereinkommen zur gegenseitigen Anerkennung von Inspektionen betreffend die Herstellung pharmazeutischer Produkte | Pharmaceutical Inspection Convention
    de
    Comment MISC: Genf, 08.10.1970.
    Pharmaceutical Inspection Convention | Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products | PIC
    en
    Definition --- Reference AUSTLIIN TREATIES: http://beta.austlii.edu.au/au/other/dfat/treaties/1993/2.html
    Comment MISC: COD;DIV: ARCHFILE47
    PIC | Convention pour la reconnaissance mutuelle des inspections concernant la fabrication des produits pharmaceutiques
    fr
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #598358

    IATE #3592841
    táirge críochnaithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Áireoidh an sainchomhad sonraí maidir le tástálacha rialaithe ar an táirge críochnaithe tráth a scaoilte.' Reference Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA
    táirge cógaisíochta críochnaithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    finished product | finished pharmaceutical product | FPP
    en
    Definition finished pharmaceutical form of a medicinal product that has undergone all stages of manufacture, including packaging in its final container and labelling Reference COM-Terminology Coordination, based on: WHO. WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). 'Glossary' (16.2.2021)
  5. 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
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #571897

    IATE #2250144
    táirge paitinne Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Originalpräparat | ursprüngliches Arzneimittel
    de
    Definition Arzneimittel, das aufgrund seiner Patentschutzzeit (zuerst) allein auf dem Markt ist Reference Barmer GEK Glossar, s. v. "Originalpräparat", https://www.barmer-gek.de/barmer/web/Portale/Versicherte/Rundum-gutversichert/Beratung/Glossar/Eintr_C3_A4ge/Originalpr_C3_A4parat.html (17.8.2015)
    Comment Bevor ein neuer Wirkstoff als Arzneimittel auf den Markt bzw. in die Apotheke kommt, muss er eine lange Reihe von klinischen Versuchen durchlaufen
    originator brand | originator | originator pharmaceutical | originator product | innovator brand | originator pharmaceutical product | originator medicinal product | originator medicine
    en
    Definition product that was first authorised worldwide for marketing (normally as a patented product) on the basis of the documentation of its efficacy, safety and quality, according to requirements at the time of authorisation Reference Originator Pharmaceutical Product/Originator Brand, English Glossary, World Health Organization, http://www.who.int/medicines/areas/coordination/English_Glossary.pdf [1.12.2015]
    Comment The originator product always has a brand name; this name may, however, vary across countries.Reference: Originator Pharmaceutical Product/Originator Brand, English Glossary, World Health Organization, http://www.who.int/medicines/areas/coordination/English_Glossary.pdf [1.12.2015]
    médicament original | médicament de marque d'origine | médicament princeps | marque innovatrice | médicament d'origine | médicament de référence | spécialité de référence | produit pharmaceutique d’origine
    fr
    Definition produit qui a été le premier à être autorisé dans le monde entier (pas seulement au niveau national) à la commercialisation (généralement en tant que produit breveté) sur la base de la preuve documentée de son efficacité, de son innocuité et de sa qualité, selon les exigences requises pour obtenir cette autorisation Reference Mesurer les prix, la disponibilité, l’accessibilité financière et les composantes des prix des médicaments, Organisation mondiale de la Santé (2008 – 2e édition), http://apps.who.int/medicinedocs/documents/s16876f/s16876f.pdf [2.10.2015]
    Comment Le produit d’origine a toujours un nom de marque (ex. Valium®), mais il peut varier selon les pays, à savoir, le fabricant peut ne pas utiliser le même nom dans tous les pays. (Source: ibid.)
  7. SOCIAL QUESTIONS|health · SOCIAL QUESTIONS|health|pharmaceutical industry

    #529852

    IATE #766937
    cógas dílseánaigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Cógas dílseánaigh is substaint íce nó ina bhfuil substaint íce do dhíol.' Reference Acht Substaintí Íce, 1932, http://acts.oireachtas.ie/framed/1932.act.025.00.frameset.html [9.1.2019]
    pharmazeutische Spezialität | Fertigarzneimittel | Originalpräparat | Arzneispezialität
    de
    Definition Arzneimittel, die im Voraus hergestellt und unter einer besonderen Bezeichnung und in einer besonderen Aufmachung in den Verkehr gebracht werden Reference RL 2001/82/EG Gemeinschaftskodex Tierarzneimittel, Art.1 (ABl. L_311/2001, S.1) CELEX:32001L0082DE ; RL 2001/83/EG Gemeinschaftskodew Humanarzneimittel, Art.1 (ABl. L_311/2001, S.67) CELEX:32001L0083DE
    Comment "unter einer bes. Bezeichnung", d.h. kein Generikum (s. IATE:766172 ); "im Voraus hergestellt", d.h. kein Rezepturarzneimittel (s. IATE:764448 ) UPD: hm, 3.10.2006
    proprietary medicine | proprietary medicinal product | proprietary preparation | proprietary pharmaceutical product | proprietary drug | drug speciality
    en
    Definition A medicinal preparation that is protected against free competition as to name, product, composition, or process of manufacture by patent, trademark, or by any other means. Reference Dorland's Illustrated Medical Dictionary, Philadelphia 1988
    spécialité pharmaceutique
    fr
    Definition Médicament préparé à l'avance, présenté sous un conditionnement particulier, caractérisé par une dénomination spéciale et enregistré au ministère de la santé. Reference Le Petit Larousse illustré, 1995.