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46 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #658062

    IATE #3572779
    monaraíocht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    déantúsaíocht Reference Comhairle-GA
    ga
    Definition monaraíocht iomlán nó pháirteach, chomh maith leis na próisis éagsúla lena ndéantar roinnt, pacáistiú agus lipéadú (lena n-áirítear dalladh) Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena naisghairtear Treoir 2001/20/CE, CELEX:02014R0536-20140527/GA"
    Herstellung | Arzneimittelherstellung
    de
    Definition vollständige oder teilweise Herstellung sowie die verschiedenen bei Abfüllung, Abpacken und Etikettierung (einschließlich Verblindung) eingesetzten Verfahren Reference "Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG (Text von Bedeutung für den EWR)Text von Bedeutung für den EWR"
    manufacturing | pharmaceutical manufacturing
    en
    Definition total and partial manufacture, as well as the various processes of dividing up, packaging and labelling (including blinding) of medicinal products Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
  2. EDUCATION AND COMMUNICATIONS|information technology and data processing|computer systems · INDUSTRY

    #658917

    IATE #3575055
    monarú suimitheach Reference Comhairle-GA
    ga
    breiseánmhónarú Reference "Togra le haghaidh Rialachán lena ndéantar córas Aontais a chur ar bun chun rialú a dhéanamh ar onnmhairiú, ar aistriú, ar bhróicéireacht agus ar chúnamh teicniúil ítimí dé-úsáide agus ar iad a bheith ar idirthuras (athmhúnlú)"
    ga
    additive Fertigung | additives Fertigungsverfahren
    de
    Definition Prozess, bei dem auf der Basis von digitalen 3D-Konstruktionsdaten durch das Ablagern von Material schichtweise ein Bauteil aufgebaut wird Reference "vgl. EOS https://www.eos.info/additive_fertigung/fuer_technologie_interessierte (30.8.18)"
    Comment "bekanntestes Beispiel: 3D-Druck IATE:1879267 Ggs.: subtraktives Fertigungsverfahren / subtraktive Fertigung IATE:3571818<><><><><><><><><><><><><><><><><><><><><><><><><><><>"
    additive manufacturing | AM | additive layer manufacturing | ALM | additive fabrication | layer based manufacturing
    en
    Definition process of building physical 3D geometries by the successive addition of material Reference "Council-EN, based on International Organization for Standardization > ISO/ASTM 52900:2015 – Additive manufacturing – General principles – Terminology, https://www.iso.org/standard/69669.html [30.11.2017]"
    Comment "As opposed to 'subtractive manufacturing' [ IATE:3571818 ]The terms 'additive manufacturing' and '3D printing' [ IATE:1879267 ] are often used interchangeably, but 'additive manufacturing' is technically a broader term which encompasses a range of technologies, of which 3D printing is just one example.Note reference: Council-EN, based, inter alia, on:- Loughborough University > Additive Manufacturing Research Group > About additive manufacturing > The 7 categories of additive manufacturing, http://www.lboro.ac.uk/research/amrg/about/the7categoriesofadditivemanufacturing/ [30.11.2017]- ASTM International, 'Standard Terminology for Additive Manufacturing Technologies', 9.9.2013, http://web.mit.edu/2.810/www/files/readings/AdditiveManufacturingTerminology.pdf [30.11.2017]"
    fabrication additive
    fr
    Definition méthode de fabrication d'un objet consistant à superposer des couches de matière à partir des données d'un modèle numérique tridimensionnel Reference "Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, http://www.culture.fr/franceterme/result?francetermeSearchTerme=fabrication+additive&francetermeSearchDomaine=0&francetermeSearchSubmit=rechercher&action=search [20.12.2017]"
    Comment "Voir aussi:- fabrication soustractive [IATE:3571818 ] - impression 3D [IATE:1879267 ]"
  3. INDUSTRY

    #602119

    IATE #151321
    ardmhonarú Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    fortgeschrittene Herstellung
    de
    advanced manufacturing
    en
    Definition manufacturing using a high level of design or scientific skills to produce technologically complex products, processes and associated services Reference "Council-EN based on High Level Group on Key Enabling Technologies, 'Thematic Report by the Working Team on Advanced Manufacturing Systems', 9.12.2010 https://ec.europa.eu/docsroom/documents/11283/attachments/7/translations/en/renditions/native and UK Department for Business Innovation & Skills, Advanced Manufacturing package https://webarchive.nationalarchives.gov.uk/20090804150949/http://www.berr.gov.uk/files/file52374.pdf [3.10.2019]"
    Comment "See also: - advanced manufacturing systems (AMS) IATE:1024135 - advanced manufacturing technologies (AMT) IATE:843029"
    fabrication avancée
    fr
    Definition fabrication de produits classiques ou nouveaux par des procédés dépendant de la coordination de divers éléments – information, automatisation, calcul, logiciel, détection et mise en réseau – et/ou utilisant des matériaux innovants et des capacités scientifiques émergentes Reference "«La prochaine révolution de la production Conséquences pour les pouvoirs publics et les entreprises: Conséquences pour les pouvoirs publics et les entreprises», 2018, Éditions OCDE, ISBN 978-92-64-28078-6 (26.11.2019)"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|production|production policy|production technique

    #630526

    IATE #1549532
    próiseas déantúsaíochta baisce Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    déantúsaíocht bhaisce Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    batch manufacturing process | batch manufacturing
    en
    Definition manufacturing of a product in multiple, discrete steps, with a production stop at the end of each step, before moving the process to the next step Reference "COM-Terminology Coordination, based on: Shane McLaughlin. 'Continuous Manufacturing vs Batch Manufacturing in the Pharmaceutical Industry' (1.2.2022). SL Controls"
    Comment Typically, production comes to a halt while samples are tested for quality offline. During these hold times, the material may be stored or shipped to other facilities globally to complete the manufacturing process. This can greatly increase the time it takes to make drugs, adding weeks or months to the process.
  5. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament

    #664320

    IATE #3591761
    monaraíocht cois leapa Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    patientennahe Herstellung
    de
    Definition Umstellung von der ausschließlich in der Fabrik erfolgenden Produktion personalisierter Arzneimittel hin zu einer Feinabstimmung am Patientenbett Reference "MITTEILUNG DER KOMMISSION AN DAS EUROPÄISCHE PARLAMENT, DEN RAT, DEN EUROPÄISCHEN WIRTSCHAFTS- UND SOZIALAUSSCHUSS UND DEN AUSSCHUSS DER REGIONEN Eine Arzneimittelstrategie für Europa"
    bedside manufacturing
    en
    Definition "manufacturing of personalised medicines which is fine-tuned at the patient’s bedside" Reference "COM-Terminology Coordination, based on:Communication - Pharmaceutical Strategy for Europe, COM(2020) 761 final"
    Comment In contrast to manufacturing of personalised medicines exclusively in factories.
    fabrication sur mesure | fabrication magistrale
    fr
    Definition fabrication de médicaments personnalisés qui ne sont plus exclusivement élaborés en usine, mais à proximité du patient et qui sont davantage adaptés à ses besoins Reference "COM-FR d’après Communication de la Commission au Parlement européen, au Conseil, au Comité économique et social européen et au Comité des régions - Stratégie pharmaceutique pour l'Europe (COM/2020/761 final)"
  6. EDUCATION AND COMMUNICATIONS|information technology and data processing|computer systems|computer applications|industrial data processing · INDUSTRY|industrial structures and policy|industrial policy|EU industrial policy

    #666700

    IATE #3626541
    Spás Sonraí Monaraíochta Reference "'Straitéis an Aontais Eorpaigh um Theicstílí Inbhuanaithe agus Ciorclacha,' an Coimisiún Eorpach, https://eur-lex.europa.eu/legal-content/EN-GA/TXT/?from=EN&uri=CELEX%3A52022DC0141 [18.7.2022]Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Spreagfaidh an Coimisiún cuideachtaí de chuid an éiceachórais teicstílí páirt a ghlacadh i dtionscnaimh chun Spás Sonraí an Chomhaontaithe Ghlais don Eoraip agus an Spás Sonraí Monaraíochta a fhorbairt chun sonraí a chomhroinnt agus a athúsáid ar bhealach níos éasca idir cuideachtaí. Cuirtear tacaíocht níos leithne ar fáil don nuálaíocht dhigiteach tríd an Líonra de Mhoil Nuálaíochta Digití Eorpacha, lena bhforbrófar na bonneagair dhigiteacha is gá chun teicneolaíochtaí digiteacha nua a thástáil agus chun cabhrú le lucht saothair na hearnála tuiscint níos fearr a fháil ar na deiseanna a bhaineann le digitiú agus a saineolas teicneolaíoch a thabhairt cothrom le dáta.' Reference "Teachtaireacht maidir le Straitéis an Aontais Eorpaigh um Theicstílí Inbhuanaithe agus Ciorclacha, CELEX:52022DC0141/GA"
    spás coiteann sonraí (monaraíocht) tionsclaíoch na hEorpa Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Datenraum für die verarbeitende Industrie | gemeinsamer europäischer Industriedatenraum (Fertigung)
    de
    Comment einer von insgesamt 9 Datenräumen für strategische Sektoren und Bereiche von öffentlichem Interesse, die im Rahmen der Datenstrategie geschaffen werden sollen: Industriedatenraum (Fertigung), Datenraum für den europäischen Grünen Deal, Mobilitätsdatenraum, Gesundheitsdatenraum, Finanzdatenraum, Energiedatenraum, Agrardatenraum, Datenräume für die öffentliche Verwaltung und Kompetenzdatenraum
    common European industrial (manufacturing) data space | manufacturing data space | Common European Manufacturing Data Space | Manufacturing Dataspace
    en
    Definition secure and trusted environment for companies to ensure enhanced access to privately held data, via industrial data platforms Reference "COM-Terminology Coordination, based on:European Commission > Shaping Europe’s digital future > Calendar > Manufacturing data spaces - predictive maintenance (6.3.2023)"
    Comment "The common European industrial (manufacturing) data space is one of nine initial domain-specific common European data spaces whose development the Commission is supporting.The aim of the common European industrial (manufacturing) data space is to support the competitiveness and performance of the EU’s industry, making it possible to harness the potential value of the use of non-personal data in manufacturing (estimated at € 1.5 trillion by 2027). As part of the European Strategy for Data, the European Commission supports the creation of common European data spaces for the manufacturing sector to ensure enhanced access to privately held data, via industrial data platforms."
    espace européen commun des données relatives à l’industrie manufacturière | espace des données manufacturières | espace européen commun de données relatives à l’industrie manufacturière | espace de données manufacturières
    fr
    Definition espace commun de données ininterrompu, sécurisé et fiable mis à la disposition des entreprises et dont l'objectif est de soutenir la compétitivité et les performances de l’industrie de l’UE et qui permet de percevoir la valeur potentielle de l’utilisation des données à caractère non personnel dans l’industrie manufacturière en les rendant accessible via des plateformes de données industrielles Reference "COM-FR, d'après : - Communication de la Commission - Une stratégie européenne pour les données, COM(2020) 66 final- Site de la Commission > Shaping Europe’s digital future > Calendar > Manufacturing data spaces - predictive maintenance (6.3.2023) (en anglais uniquement)"
    Comment "1. Un des neuf espaces européens communs des données propres à un domaine, définis dans la stratégie européenne pour les données et dont le développement est soutenu par la Commission.2. Au sein de ces espaces, les fournisseurs, utilisateurs et intermédiaires de données respectent les mêmes normes concernant le stockage et partagent des données liées à leur domaine respectif, afin d'entraîner la mise à disposition de vastes réserves communes de données. Ces réserves sont combinées aux outils et infrastructures techniques nécessaires pour utiliser et échanger ces données, ainsi qu’à des mécanismes de gouvernance appropriés."
  7. INTERNATIONAL RELATIONS|international affairs|international agreement · EUROPEAN UNION|European construction|EU relations · LAW · TRADE|trade policy

    #612965

    IATE #898828
    Comhthuiscint maidir le prionsabail an chomhair idirnáisiúnta i ngníomhaíochtaí taighde agus forbartha i réimse na gCóras Monaraíochta Cliste idir an Comhphobal Eorpach agus Stáit Aontaithe Mheiriceá, an tSeapáin, an Astráil, Ceanada agus na baill sin de CSTE an Iorua agus an Eilvéis Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Verständigung über die Grundsätze der internationalen Zusammenarbeit bei Forschung und Entwicklung im Bereich der intelligenten Fertigungssysteme zwischen der Europäischen Gemeinschaft und den Vereinigten Staaten von Amerika, Japan, Australien, Kanada und den EFTA-Ländern Norwegen und der Schweiz
    de
    Common Understanding on the principles of international cooperation in research and development activities in the domain of Intelligent Manufacturing Systems between the European Community and the United States of America, Japan, Australia, Canada and the EFTA countries of Norway and Switzerland
    en
    Entente dégagée à propos des principes de coopération internationale en matière d'activités de recherche et de développement dans le domaine des systèmes de fabrication intelligents entre la Communauté européenne et les Etats-Unis d'Amérique, le Japon, l'Australie, le Canada et les pays AELE de Norvège et de Suisse | échange de lettres rendant compte des principes de coopération internationale en matière d'activités de recherche et de développement dans le domaine des systèmes de fabrication intelligents entre la Communauté européenne et les Etats-Unis d'Amérique, le Japon, l'Australie, le Canada et les pays AELE de Norvège et de Suisse
    fr
  8. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|production|production policy|production technique

    #651454

    IATE #3552808
    monaraíocht leanúnach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás monaraíocht leanúnach, féadfar méid na baisce tráchtála a chur in iúl i dtéarmaí tréimhse ama nó cainníocht táirge, agus féadfar é a chur in iúl mar réimsí.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    kontinuierliche Herstellung
    de
    Comment MISC: aus EG-Wörterverzeichnis.
    continuous manufacturing | continuous manufacture | continuous production | continuous manufacturing process | CM | continuous pharmaceutical manufacturing
    en
    Definition pharmaceutical production method in which pharmaceuticals move nonstop within the same facility with no hold times Reference "'Continuous Manufacturing: Batch to the Future' (21.1.2021). Division of Pharmacy Professional Development University of Wisconsin - Madison School of Pharmacy"
    Comment 1) The standard pharmaceutical production method for over 50 years has been batch manufacturing. Batch manufacturing is a multi-step, lengthy process that involves large-scale equipment.2) To date, there has been no standardised definition of CM, and the terms ‘continuous manufacturing’, ‘continuous production’ and ‘continuous processing’ are often intermingled. Nonetheless, these terms are not interchangeable as they have different nuances. As the name suggests, ‘continuous production’ refers to a production schedule operating continually for 24 hours, seven days a week. On the other hand, ‘continuous processing’ refers to a single unit operation where raw materials are continuously being loaded, processed, and unloaded without interruption.
    fabrication en continu
    fr
  9. INTERNATIONAL RELATIONS|international affairs|international agreement

    #608225

    IATE #812045
    an Coinbhinsiún maidir le Staitisticí a bhaineann le Pá agus le hUaireanta Oibre sna Príomhthionscail Mianadóireachta agus Déantúsaíochta lena n-áirítear an Fhoirgníocht agus an Tógáil, agus sa Talmhaíocht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Übereinkommen über Statistiken der Löhne und der Arbeitszeit in den hauptsächlichsten Zweigen des Bergbaus und der Industrie, einschließlich des Baugewerbes, und in der Landwirtschaft | Übereinkommen über die Statistiken der Löhne und der Arbeitszeit
    de
    Comment CONTEXT: Kontext: Internationale Arbeitsorganisation (IAO).;XREF: Revidiert durch das IAO-Übereinkommen Nr. 160 vom 25.06.1985.;MISC: Genf, 20.06.1938.
    Convention concerning Statistics of Wages and Hours of Work in the Principal Mining and Manufacturing Industries, Including Building and Construction, and in Agriculture | Convention concerning Statistics of Wages and Hours of Work, 1938
    en
    Comment Date of adoption 20.6.1938 Date of entry into force: 22.6.1940 C63
    Convention concernant les statistiques des salaires et des heures de travail dans les principales industries minières et manufacturières, y compris le bâtiment et la construction, et dans l'agriculture | Convention concernant les statistiques des salaires et des heures de travail, 1938 (C63)
    fr
    Comment Date d'adoption:20:06:1938; Date d'entrée en vigueur: 22:06:1940 C63
  10. INTERNATIONAL RELATIONS|defence · INDUSTRY|industrial structures and policy

    #667431

    IATE #3628122
    cumas tionsclaíoch cosanta Reference "Cruinniú urghnách den Chomhairle Eorpach (30 agus 31 Bealtaine 2022) (7.7.2022)"
    ga
    Context '..go háirithe i bhfianaise na tacaíochta a thugtar don Úcráin, chomh maith le huirlis ghearrthéarmach a bhunú chun cumais thionsclaíocha cosanta na hEorpa a atreisiú trí sholáthar comhpháirteach ar bhonn deonach;' Reference "Cruinniú urghnách den Chomhairle Eorpach (30 agus 31 Bealtaine 2022) (7.7.2022)"
    cumas monaraíochta cosanta Reference st8231, conclúidí ón gComhairle Eorpach, Bealtaine 2022
    ga
    Fähigkeit der Verteidigungsindustrie | Kapazität der Verteidigungsindustrie | industrielle Verteidigungsfähigkeit
    de
    defence industrial capability | defence-industrial capability | defence manufacturing capability
    en
    Definition a skill, facility, process, or technology needed to design, develop, produce, repair or maintain products used in the defence sector Reference "Council-EN based on: AcqNotes > Production, Quality and Manufacturing > Industrial Capabilities and Assessment (20.5.2022)"
    capacités industrielles de défense
    fr
    Definition infrastructures, moyens matériels, technologies et savoir-faire dont dispose un pays pour produire les moyens et équipements nécessaires à sa défense Reference "Conseil-FR, d'après- Bulletin économique de la défense, Les enjeux de la mutualisation du soutien dans le domaine de la défense en Europe (23.5.2022)- Site du Sénat, Les capacités militaires industrielles critiques (23.5.2022)"
  11. AGRI-FOODSTUFFS

    #657120

    IATE #3571248
    pointe deiridh sa slabhra monaraíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ar mhaithe le deimhneacht dhlíthiúil agus rialú ceart a dhéanamh ar rioscaí ionchasacha, ba cheart pointe deiridh sa slabhra monaraíochta a chinneadh do tháirgí gan ábharthacht dhíreach do shábháilteacht an tslabhra beathaithe acu a thuilleadh. I gcás táirgí áirithe a rialaítear faoi reachtaíocht eile Chomhphobail, ba cheart pointe deiridh den sórt sin a chinneadh ag an gcéim monaraíochta. Ba cheart táirgí a bhain an pointe deiridh seo amach a bheith díolmhaithe ó shrianta faoin Rialachán seo. Ba cheart go háirithe go gceadófaí táirgí i ndiaidh an phointe deiridh a chur ar an margadh gan srian faoin Rialachán seo agus féadfaidh oibreoirí, nach bhfuil formheasta ná cláraithe i gcomhréir leis an Rialachán seo, iad a láimhseáil agus iad a iompar.' Reference "Rialachán (CE) Uimh. 1069/2009 lena leagtar síos rialacha sláinte maidir le seachtháirgí ainmhithe agus táirgí díorthaithe nach bhfuil ceaptha mar bhia don duine agus lena n-aisghairtear Rialachán (CE) Uimh. 1774/2002 (Rialachán maidir le seachtháirgí ainmhithe), CELEX:32009R1069/GA"
    Endpunkt in der Herstellungskette | Endpunkt in der Fertigungskette
    de
    Definition Punkt in der Herstellungskette, ab dem ein Produkt ohne Einschränkungen durch gemeinschaftsrechtliche Vorschriften in Verkehr gebracht werden kann Reference "Council-DE auf Grundlage der Verordnung (EG) Nr. 1069/2009 mit Hygienevorschriften für nicht für den menschlichen Verzehr bestimmte tierische Nebenprodukte, Art. 5 CELEX:32009R1069/DE"
    end point in the manufacturing chain
    en
    Definition point in the manufacturing chain beyond which a product may be placed on the market without restrictions under Community legislation Reference "Council-SK based on: Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption, CELEX:32009R1069/EN"
    point final de la chaîne de fabrication
    fr
    Definition point dans la chaîne de fabrication au-delà duquel aucune exigence de santé publique ou animale ne s’applique à la mise sur le marché Reference "Proposition de règlement établissant des règles sanitaires applicables aux sous-produits animaux non destinés à la consommation humaine («règlement relatif aux sous-produits animaux»)"
  12. EMPLOYMENT AND WORKING CONDITIONS|labour law and labour relations · INTERNATIONAL ORGANISATIONS|European organisations

    #657607

    IATE #3572001
    industriAll Europe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ceardchumann Eorpach industriAll Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    industriAll European Trade Union | European Federation for Industry and Manufacturing workers | industriAll Europe
    en
    Definition federation of independent and democratic trade unions representing manual and non-manual workers in the metal, chemical, energy, mining, textile, clothing and footwear sectors and related industries and activities Reference "industriAll Europe official website > About us [13.3.2017]"
    Comment "One of the European trade union federations [ IATE:3571919 ] affiliated to the European Trade Union Confederation (ETUC) [ IATE:1915339 ]."
  13. PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations|technology · PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations|technical regulations|standardisation · INDUSTRY

    #603548

    IATE #378516
    Prionsabail Dhomhanda Monaraíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    GMP | Global Manufacturing Principles
    en
    Comment Mattel's code of practice dating from 1997; it commits the toy manufacturer to working in compliance with ethical standards.
  14. SOCIAL QUESTIONS|health|pharmaceutical industry

    #628555

    IATE #1442965
    dea-chleachtas déantúsaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    dea-chleachtas monaraíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Gute Herstellungspraxis | GHP
    de
    Definition der Teil der Qualitätssicherung, der gewährleistet, daß Produkte gleichbleibend nach den Qualitätsstandards produziert und geprüft werden, die der vorgesehenen Verwendung entsprechen Reference Richtlinie 91/356/EWG der Kommission zur Festlegung der Grundsätze und Leitlinien der Guten Herstellungspraxis für zur Anwendung beim Menschen bestimmte Arzneimittel
    good manufacturing practice | GMP
    en
    Definition part of quality assurance (the total sum of the organised arrangements made with the object of ensuring that medicinal products or investigational medicinal products are of the quality required for their intended use) which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use Reference "COM-Terminology Coordination, based on:Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use CELEX:32003L0094/EN"
    Comment "More information can be found under EMA website, Home > Human regulatory > Inspections > GMP/GDP compliance http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000154.jsp&mid=WC0b01ac0580027088"
    bonnes pratiques de fabrication | BPF
    fr
    Definition l'élément de l'assurance de la qualité qui garantit que les médicaments sont fabriqués et contrôlés de façon cohérente et selon les normes de qualité adaptées à leur emploi Reference Directive 91/356/CEE de la Commission établissant les principes et lignes directrices de bonnes pratiques de fabrication pour les médicaments à usage humain
  15. SOCIAL QUESTIONS|health|health policy|organisation of health care|pharmaceutical legislation · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #668028

    IATE #3629740
    cigireacht maidir le dea‑chleachtas monaraíochta Reference "Togra le aghaidh Rialachán maidir le táillí agus muirir is iníoctha leis an nGníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (AE) 2017/745 ó Pharlaimint na hEorpa agus ón gComhairle agus lena n‑aisghairtear Rialachán (CE) Uimh. 297/95 ón gComhairle agus Rialachán (AE) 658/2014 ó Pharlaimint na hEorpa agus ón gComhairle,CELEX:52022PC0721/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Good Manufacturing Practice inspection | GMP inspection
    en
    Definition "inspection intended to achieve the verification of compliance with the principles of 'good manufacturing practice'" Reference "COM-Terminology Coordination, based on: Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency"
  16. INTERNATIONAL RELATIONS|international affairs|international agreement · INTERNATIONAL RELATIONS|defence|military equipment · INTERNATIONAL ORGANISATIONS|extra-European organisations|American organisation

    #613987

    IATE #914294
    an Coinbhinsiún Idir-Mheiriceánach i gcoinne déantúsaíocht neamhdhleathach agus gáinneáil arm tine, armlón, pléascán, agus ábhar gaolmhar Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Inter-American Convention against the Illicit Manufacturing of and Trafficking in Firearms, Ammunition, Explosives and Other Related Materials | Inter-American Convention against the Illegal Manufacturing of and Trafficking in Firearms, Ammunition, Explosives, and Other Related Materials | CIFTA
    en
    Comment "Approved during the First Plenary Session held on 13 November 1997. ; See also: Organization of American States IATE:787697"
    Convention interaméricaine contre la fabrication et le trafic illicites d'armes à feu, de munitions, d'explosifs et d'autres matériels connexes | CIFTA | Convention interaméricaine contre la fabrication et le trafic illicite d'armes à feu, de munitions, d'explosifs et d'autres matériels connexes
    fr
    Comment CONTEXT: Organisation des Etats américains;MISC: 1997
  17. BUSINESS AND COMPETITION|business organisation|business policy · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|intellectual property

    #606794

    IATE #789124
    rún ceirde Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Betriebs- und Geschäftsgeheimnis | Betriebsgeheimnis | Geschäftsgeheimnis
    de
    Definition alles, was mit e. Geschäftsbetrieb im Zus.hang steht, nicht offenkundig ist u. nach dem Willen des Betriebsinhabers geheim gehalten werden soll, weil e. Bekanntwerden die Wettbewerbsfähigkeit d. Betriebs schädigt; Geschäftsgeheimnis: z.B. Kunden- u. Preislisten, Kalkulationen, techn. Daten von Maschinen, Umsatzzahlen Reference ---
    Comment "XREF: s. ""Betriebsgeheimnis"" (Karte A152005)"
    trade secret | manufacturing and business secrets
    en
    Definition information which is not generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question, has commercial value because it is secret, and has been subject to reasonable steps to keep it secret Reference "Council-EN, based on Directive (EU) 2016/943 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure, Article 2 - Definitions, point 1 'trade secret'."
    Comment Covers any kind of information an organisation keeps confidential to preserve competitive gains, whether it refers to industrial processes, strategic information or otherwise.1The definition of trade secret in the Directive excludes trivial information and the experience and skills gained by employees in the normal course of their employment, and also excludes information which is generally known among, or is readily accessible to, persons within the circles that normally deal with the kind of information in question.2
    secret d'affaires | secret des affaires | secret industriel et commercial | secret en matière industrielle et commerciale
    fr
    Definition informations commerciales et savoir-faire détenus par une entreprise dont le caractère secret présente une valeur, qui font l'objet de mesures pour en préserver la confidentialité et dont la divulgation est considérée nuisible à ses intérêts Reference "Conseil-FR, d'après:- Directive (UE) 2016/943 sur la protection des savoir-faire et des informations commerciales non divulgués (secrets d'affaires) contre l'obtention, l'utilisation et la divulgation illicites- SPF économie, Accueil > Thèmes > Propriété intellectuelle > Innovation et propriété intellectuelle > Secret d’inventions, du savoir-faire ou d’informations (24.4.2020)- Wikipédia, article Droit du secret des affaires (24.4.2020) "
    Comment "La protection conférée à ce type d'informations, qui existe de longue date en droit anglo-saxon, n'a été introduite en droit européen qu'avec la directive (UE) 2016/943 sur le secret d'affaires.Elle est évoquée dans l'Accord sur les ADPIC sous le terme de ""protection des renseignements non divulgués"" (art. 39)."
  18. SOCIAL QUESTIONS|health|pharmaceutical industry

    #631949

    IATE #1589657
    údarú monaraíochta 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
    Herstellungserlaubnis
    de
    manufacturing authorisation | manufacturing authorization
    en
    Definition authorisation to manufacture a medicinal product in the territory of a Member State of the EU, even if the medicinal products manufactured are intended for export Reference "COM-Terminology Coordination, based on: Directive 2001/83/EC on the Community code relating to medicinal products for human use"
  19. INDUSTRY|industrial structures and policy|industrial production · SOCIAL QUESTIONS|health|pharmaceutical industry · INDUSTRY|chemistry|chemical industry

    #638423

    IATE #2155171
    baisc mhonaraíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    manufacturing batch
    en
    Definition "batch produced during a batch manufacturing process" Reference "COM-Terminology Coordination, based on: Government of Canada. 'Good manufacturing practices guide for drug products (GUI-0001)' (6.4.2022)"
    lot de fabrication
    fr
  20. TRADE|tariff policy|customs regulations · TRADE|consumption|consumer · PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations

    #608866

    IATE #837667
    fabht sa déantúsaíocht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tarscaoilfidh na húdaráis custaim an ceanglas a leagtar síos sa chéad fhomhír, áfach, más rud é gur cuireadh an táirge athsholáthair ar fáil saor in aisce, de bharr oibleagáide conarthaí nó de bharr oibleagáide reachtúla mar chuid de ráthaíocht nó de bharr fabht sa déantúsaíocht nó san ábhar.' Reference "Rialachán (CE) Uimh. 450/2008 lena leagtar síos Cód Custaim an Chomhphobail (Cód Custaim Nuachóirithe), CELEX:32008R0450/GA"
    Herstellungsfehler
    de
    Comment CONTEXT: interner Gebrauch beim WSA.;MISC: aus EG-Wörterverzeichnis.
    manufacturing defect
    en
    Definition frailty or shortcoming in a product resulting from a departure from its design specifications during production Reference "BusinessDictionary.com, s.v. manufacturing defect, http://www.businessdictionary.com/definition/manufacturing-defect.html [29.4.2013]"
    défaut de fabrication
    fr