Gaois

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16 results

  1. AGRICULTURE, FORESTRY AND FISHERIES|means of agricultural production|means of agricultural production|plant health product

    #624096

    IATE #1255806
    substaint ghníomhach Reference "Rialachán Cur Chun Feidhme (AE) 2022/782 lena dtarraingítear siar an formheas ar an tsubstaint ghníomhach isipiorasam i gcomhréir le Rialachán (CE) Uimh. 1107/2009 ó Pharlaimint na hEorpa agus ón gComhairle maidir le táirgí cosanta plandaí a chur ar an margadh, agus lena leasaítear Rialachán Cur Chun Feidhme (AE) Uimh. 540/2011 agus lena n-aisghairtear Rialachán Cur Chun Feidhme (AE) Uimh. 1037/2012 ón gCoimisiún, CELEX:32022R0782/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Maidir le haon úsáid ionadaíoch amháin nó níos mó a bhaintear as, ar a laghad, táirge cosanta plandaí amháin ina bhfuil an tsubstaint ghníomhach, agus go háirithe na húsáidí a scrúdaíodh agus a sonraíodh sa tuarascáil athbhreithniúcháin, is éard a suíodh gurbh amhlaidh a comhlíonadh na critéir formheasa dá bhforáiltear in Airteagal 4 de Rialachán (CE) Uimh. 1107/2009.' Reference "Rialachán Cur Chun Feidhme (AE) 2021/567 lena bhformheastar eastóscán uiscí ó shíolta péactha an lúipín bháin mhilis, substaint ghníomhach a bhfuil riosca íseal ag baint léi, i gcomhréir le Rialachán (CE) Uimh. 1107/2009 ó Pharlaimint na hEorpa agus ón gComhairle maidir le táirgí cosanta plandaí a chur ar an margadh, agus lena leasaítear Rialachán Cur Chun Feidhme (AE) Uimh. 540/2011 ón gCoimisiún, CELEX:32021R0567/GA"
    Wirkstoff | aktive Substanz | Grundwirkstoff | wirksamer Bestandteil
    de
    Definition Stoff, einschließlich Mikroorganismen, mit allgemeiner oder spezifischer Wirkung gegen Schadorganismen an Pflanzen, Pflanzenteilen oder Pflanzenerzeugnissen Reference "Verordnung (EG) Nr. 1107/2009 über das Inverkehrbringen von Pflanzenschutzmitteln"
    Comment Kontext: Pflanzenschutzmittel
    active substance | active ingredient
    en
    Definition any substance, including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products Reference "Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, CELEX:02009R1107-20181110/EN"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #600660

    IATE #35093
    substaint ghníomhach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'EUR 145200 i gcás ina n-áirítear trí shubstaint ghníomhacha agus/nó trí theaglaim de shubstaintí gníomhacha sa mheasúnú...' Reference "Rialachán (AE) Uimh. 658/2014 maidir le táillí is iníoctha leis an nGníomhaireacht Leigheasra Eorpach chun gníomhaíochtaí cógas-aireachais a dhéanamh i ndáil le táirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0658/GA"
    substaint atá gníomhach ó thaobh na cógaseolaíochta de Reference "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, CELEX:32009R0470/GA"
    ga
    Wirkstoff | wirksamer Bestandteil | arzneilich wirksamer Bestandteil | pharmakologisch wirksamer Stoff | Arzneistoff
    de
    Definition Stoff, der bei der Herstellung eines Arzneimittels zu einem seiner pharmakologisch wirksamen Bestandteile wird Reference "Council-DE, vgl. Verordnung (EU) 2019/6 über Tierarzneimittel, Art. 4 Abs. 3"
    Comment """Anders formuliert sind Wirkstoffe also diejenigen Bestandteile eines Arzneimittels, die für seine Wirksamkeit verantwortlich sind."""
    active substance | pharmacologically active substance | active ingredient | therapeutic entity | therapeutic substance
    en
    Definition substance responsible for the pharmacological activity of a medicinal product Reference "COM-Terminology Coordination, based on: 'active substance' (26.7.2023). EMA. Glossary"
    Comment "The quantity of the active substance should be expressed per dosage unit (for metered dose inhalation products, per delivered dose and/or per metered dose), per unit volume, or per unit of weight and should be related to the declaration of strength in section 1. Quantity should be expressed in internationally recognised standard term which could be complemented with another term if more meaningful to healthcare professionals."
    substance active
    fr
  3. AGRICULTURE, FORESTRY AND FISHERIES|agricultural activity|animal nutrition

    #654160

    IATE #3565743
    substaint ghníomhach Reference "Rialachán (CE) Uimh. 1107/2009 maidir le táirgí cosanta plandaí a chur ar an margadh agus lena n-aisghairtear Treoir 79/117/CEE agus Treoir 91/414/CEE ón gComhairle, CELEX:32009R1107/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Ní fhormheasfar substaint ghníomhach, ina haonar nó i gcomhar le teorantóir nó le sineirgíoch, ach amháin i gcás ina suitear, maidir le húsáid ionadaíoch amháin nó níos mó, go bhfuil an táirge cosanta plandaí sách éifeachtach tar éis é a úsáid i gcomhréir le dea-chleachtas cosanta plandaí agus ag féachaint do dhálaí réalaíocha úsáide.' Reference "Rialachán (CE) Uimh. 1107/2009 maidir le táirgí cosanta plandaí a chur ar an margadh agus lena n-aisghairtear Treoir 79/117/CEE agus Treoir 91/414/CEE ón gComhairle, CELEX:32009R1107/GA"
    Wirkstoff
    de
    active substance
    en
    substance active
    fr
  4. SOCIAL QUESTIONS|health|medical science · SOCIAL QUESTIONS|health|pharmaceutical industry

    #617685

    IATE #1073753
    baictéiricíd Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Bakterizid | antibakterieller Wirkstoff | antibakterielles Arzneimittel | bakterizide Substanz | bakterientötende Substanz | Bakterien tötendes Mittel | antibakterielles Mittel
    de
    Definition Antibiotika oder Desinfektionsmittel, die Bakterien so stark schädigen, dass sie den irreversiblen Zelltod der Erreger auslösen Reference "DocCheckFlexikon, s. v. „Bakterizid“, http://flexikon.doccheck.com/de/Bakterizid (27.9.2017)"
    bactericide | bacteriocide | bacteriocidal | bactericidal | bactericidal compound | compounds
    en
    Definition substance that kills bacteria Reference "Wikipedia http://en.wikipedia.org/wiki/Bactericide [21.9.2010]"
    bactéricide | composé bactéricide | substance à activité bactéricide
    fr
    Definition antibiotique agissant sur les bactéries en les tuant Reference Dict.de médecine,Flammarion
  5. 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"
  6. INDUSTRY|chemistry|special chemicals

    #629434

    IATE #1479800
    bithicíd Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biozider Wirkstoff | Wirkstoff eines Biozidprodukts | Biozid
    de
    biocidal active substance | active substance of a biocidal product
    en
    Definition "active substance contained in a biocidal product11biocidal product [ IATE:806901 ]" Reference "COM-Terminology Coordination, based on:Regulation (EU) 2015/416 approving dinotefuran as an active substance for use in biocidal products for product-type 18, CELEX:32015R0416"
    substance active biocide | substance active d'un produit biocide | biocide
    fr
    Definition substance ou microorganisme contenu dans un produit biocide et qui exerce une action sur ou contre les organismes nuisibles Reference "COM-FR, d’après le Règlement (UE) n° 528/2012 du Parlement européen et du Conseil concernant la mise à disposition sur le marché et l’utilisation des produits biocides, CELEX:32012R0528/FR [11.1.2018]"
    Comment "Voir aussi: produit biocide [IATE:806901 ]"
  7. SOCIAL QUESTIONS|social affairs · SOCIAL QUESTIONS|health · INDUSTRY|chemistry

    #651964

    IATE #3555927
    substaint ar nós eacstaise Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ecstasy-ähnliche Substanz | Ecstasy-ähnlicher Wirkstoff | Ecstasy-ähnliche Droge
    de
    Comment "XREF: Ecstasy IATE:1399910"
    ecstasy-like substance | ecstasy-type drug | ecstasy analogue
    en
    Definition "any substance matching the effects of ecstasy [ IATE:1399910 ]" Reference "COM-Terminology Coordination, based on:M. G. BOSSONG, J. P. VAN DIJK & R. J. M. NIESINK. Methylone and mCPP, two new drugs of abuse?, Addiction Biology (December 2005) 10, 321 – 323, http://bitnest.ca/external.php?id=%257DbxUgPZC%251B%2506%2501q%257C%257D%2505%2505R%255BQ%2501QIptd [7.3.2014]"
    substance analogue à l'ecstasy
    fr
  8. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666529

    IATE #3623642
    substaint ghníomhach aon-náisiúnta 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 substaint ghníomhach a úsáidtear i dtáirge íocshláinte imscrúdaitheach i dtriail chliniciúil nó i dtrialacha cliniciúla nach n-údaraítear ach in aon Bhallstát amháin 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"
    mononationaler Wirkstoff
    de
    Definition "Wirkstoff, der in einem Prüfpräparat in (einer) klinischen Prüfung(en) verwendet wird, die in nur einem Mitgliedstaat genehmigt wurde(n)" Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    mono-national active substance
    en
    Definition "active substance, which is used in an investigational medicinal product in a clinical trial or trials authorised in only one Member State" Reference "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"
    substance active étudiée dans un seul pays
    fr
    Definition "substance active utilisée dans un médicament expérimental lors d’un ou de plusieurs essais cliniques autorisés dans un seul État membre" Reference "Règlement d’exécution (UE) 2022/20 de la Commission du 7 janvier 2022 portant modalités d’application du règlement (UE) nº 536/2014 du Parlement européen et du Conseil en ce qui concerne la mise en place des règles et procédures de coopération entre les États membres dans le cadre de l’évaluation de la sécurité des essais cliniques"
  9. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666536

    IATE #3623651
    substaint ghníomhach ilnáisiúnta 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 substaint ghníomhach a úsáidtear i dtáirge íocshláinte imscrúdaitheach i dtriail chliniciúil nó i dtrialacha cliniciúla a údaraítear i níos mó ná aon Bhallstát amháin 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"
    multinationaler Wirkstoff
    de
    Definition "Wirkstoff, der in einem Prüfpräparat in (einer) klinischen Prüfung(en) verwendet wird, die in mehr als einem Mitgliedstaat genehmigt wurde(n)" Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    multi-national active substance
    en
    Definition "active substance which is used in an investigational medicinal product in a clinical trial or trials authorised in more than one Member State" 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"
  10. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666534

    IATE #3623648
    substaint ghníomhach nua le haghaidh comhar sábháilteachta 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 substaint ghníomhach nár úsáideadh cheana i dtáirge íocshláinte imscrúdaitheach in aon triail chliniciúil ar bith arna húdarú san Aontas faoi Rialachán (AE) Uimh. 536/2014, agus dá bhrí sin, nach bhfuil Ballstát measúnaithe sábháilteachta sannta di 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"
    neuer der Zusammenarbeit auf dem Gebiet der Sicherheit unterliegender Wirkstoff
    de
    Definition "Wirkstoff, der bisher nicht in einem Prüfpräparat in einer in der Union nach der Verordnung (EU) Nr. 536/2014 genehmigten klinischen Prüfung verwendet wurde und daher keinem die Sicherheit bewertenden Mitgliedstaat zugewiesen ist" Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    new active substance for safety cooperation
    en
    Definition "active substance which has not been previously used in an investigational medicinal product in any clinical trial authorised in the Union under Regulation (EU) No 536/2014, and therefore does not have an assigned safety assessing Member State" 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"
  11. SOCIAL QUESTIONS|health|pharmaceutical industry

    #668930

    IATE #3639137
    eintiteas teiripeach nua Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comment <<<_not_supplied_>>>
    neuer therapeutischer Wirkstoff
    de
    new therapeutic entity | NTE
    en
    Definition medicinal product that addresses an unmet patient need and is based on a known molecule, is formulated or used in a novel way, and has shorter development timelines and lower costs Reference "COM-Terminology Coordination, based on: Fereshteh Barei, Malcolm Ross. 'The refinement of the super generic concept: semantic challenge for product re-innovation?' (23.3.2023) GaBI Journal. Volume 4 | 2015 | Issue 1"
    nouvelle entité thérapeutique
    fr
    Definition médicament répondant à un besoin non satisfait des patients, aux coûts et aux délais de développement réduits, formulé ou employé d’une manière innovante à partir d’une molécule connue Reference "COM-FR, d'après le site GaBiJournal - Generics and Biosimilars Initiative Journal > The refinement of the super generic concept: semantic challenge for product re-innovation? (31.5.2023) Fereshteh Barei, Malcolm Ross, (2015), Volume 4, Issue 1 (uniquement en anglais)"
  12. SOCIAL QUESTIONS|health|pharmaceutical industry

    #637034

    IATE #1890248
    comhábhar gníomhach cógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'D’fhéadfadh a bheith san áireamh sna bearta sin bearta chun astaíochtaí ó mhonarú a laghdú trí na Teicnící is Fearr atá ar Fáil (BAT) faoi Threoir 2010/75/AE ó Pharlaimint na hEorpa agus ón gComhairle a leanúint, go háirithe más rud é gur sainaithníodh astú comhábhar gníomhach cógaisíochta mar shaincheist ríthábhachtach chomhshaoil le linn na Doiciméid Tagartha ábhartha um na Teicnící is Fearr atá ar Fáil (BREFanna) agus conclúidí BAT a ghabhann leo a bheith á ndréachtú nó á n-athbhreithniú.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    pharmazeutischer Wirkstoff | Wirkstoff
    de
    Definition Stoff, der dazu bestimmt ist, bei der Herstellung von Arzneimitteln als arzneilich wirksamer Bestandteil verwendet zu werden oder bei seiner Verwendung in der Arzneimittelherstellung zu einem arzneilich wirksamen Bestandteil des Arzneimittels zu werden Reference "Vgl. Arzneimittelgesetz (DE) http://www.gesetze-im-internet.de/bundesrecht/amg_1976/gesamt.pdf (8.08.13)"
    Comment "die Europäische Kommission hat im Februar 2013 einen Entwurf für neue ""Good Distribution Practices (GDP)""-Anforderungen für Wirkstoffe mit umfassenden neuen Regelungen vorgelegt; DIV: aka 8.08.13"
    API | active pharmaceutical ingredient | drug substance | active substance
    en
    Definition any substance or mixture of substances which is intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient of the drug product, and which is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body Reference "COM-Terminology Coordination, based on:European Medicines Agency (EMA). 'ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients' (7.4.2020). November 2000. CPMP/ICH/4106/00"
    ingrédient pharmaceutique actif | principe actif | substance active
    fr
  13. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648552

    IATE #3542065
    tuarascáil thréimhsiúil chun dáta maidir le sábháilteacht i gcás substaint aonair Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    tuarascáil aonair thréimhsiúil chun dáta maidir le sábháilteacht Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    regelmäßig aktualisierter Sicherheitsbericht über einen einzigen Wirkstoff | Sicherheitsbericht über einen einzigen Wirkstoff
    de
    single-substance PSUR | single substance PSUR | single-substance periodic safety update report | single periodic safety update report | single PSUR | single agent PSUR
    en
    Definition "periodic safety update report [ IATE:3535677 ] covering all products containing the same active substance [ IATE:35093 ] authorised to one marketing authorisation holder; periodic safety update report [ IATE:3535677 ] covering all products containing the same active substance [ IATE:35093 ] authorised to one marketing authorisation holder" Reference "COM-EN, based on: European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VII – Periodic safety update report. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123207.pdf [23.4.2012] & European Medicines Agency. ICH Topic E 2 C (R1). Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. Step 5. Note For Guidance On Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf [28.3.2012]& MHRA (Medicines and Healthcare products Regulatory Agency) > How we regulate > Medicines > Licensing of medicines > Information for licence holders > Periodic Safety Update Reports, http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/PeriodicSafetyUpdateReports/index.htm [23.4.2012]"
    rapport périodique de sécurité unique
    fr
    Definition "rapport périodique de sécurité [ IATE:3535677 ] établi pour des médicaments contenant la même substance active" Reference "TERM-FR, d'après: Conseil de l'Union européenne, Effets indésirables des médicaments: le Conseil prend des mesures, 29 novembre 2010, http://register.consilium.europa.eu/pdf/fr/10/st17/st17054.fr10.pdf [8.10.2012]"
  14. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #641691

    IATE #3503253
    Máistirchomhad maidir le Substaintí Gníomhacha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Le haghaidh substaint ghníomhach, féadfaidh monaróir na substainte gníomhaí nó an t-iarratasóir a shocrú go gcuirfidh monaróir na substainte gníomhaí an fhaisnéis seo a leanas ar fáil i ndoiciméad ar leithligh go díreach do na húdaráis inniúla mar Mháistirchomhad maidir le Substaintí Gníomhacha: (a) tuairisc mhionsonraithe ar an bpróiseas monaraíochta; (b) tuairisc ar an rialú cáilíochta le linn na monaraíochta; (c) tuairisc ar an bpróiseas bailíochtaithe.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Máistirchomhad Substainte Gníomhaí Reference "Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0017/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    ASMF Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh sealbhóir ASMF ionchorpraithe cheana féin i gcórais TF an Aontais lena ndéantar sonraí eagraíochtúla a stóráil agus a sholáthar.' Reference "Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0017/GA"
    Wirkstoff-Stammdokumentation | Wirkstoff-Stammdatei | ASMF
    de
    Definition beliebtes Instrumentarium für den Wirkstoffhersteller, um seine Informationen vertraulich und nur der Behörde gegenüber zu veröffentlichen Reference COM-DE, gestützt auf: Gengenbach, R., Gengenbach, R.J., Eckert, H.G. & Hähnel, W. (2008). GMP-Qualifizierung und Validierung von Wirkstoffanlagen: ein Leitfaden für die Praxis. 1. Aufl. Weinheim, Bergstr: WILEY-VCH. S. 66.
    Active Substance Master File | ASMF | Drug Master File | DMF | European Drug Master File | EDMF
    en
    Definition document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation prepared in a separate document by the manufacturer of the active substance Reference "Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
    Comment A “master file” is a document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation prepared in a separate document by the manufacturer of the active substance. An “active substance master file” is such a document concerning an active substance. An “additional quality master file” is such a document concerning active substances other than chemical active substances, or on other substances present or used in the manufacture of a medicinal product, like excipients
    dossier permanent de la substance active
    fr
    Definition document contenant une description détaillée du procédé de fabrication, du contrôle de la qualité pendant la fabrication et de la validation du procédé, établi sous forme de document distinct par le fabricant de la substance active Reference "Proposition de DIRECTIVE DU PARLEMENT EUROPÉEN ET DU CONSEIL instituant un code de l’Union relatif aux médicaments à usage humain et abrogeant la directive 2001/83/CE et la directive 2009/35/CE, COM(2023) 192"
  15. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #665586

    IATE #3599402
    substaint ghníomhach a cuireadh ar ais Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Substaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta a aisghaireadh, déanfar iad a shainaithint amhlaidh, agus déanfar iad a leithscaradh go fisiceach nó, má tá córas coibhéiseach leictreonach ar fáil, go leictreonach go dtí go bhfaighfear toradh imscrúdaithe ar na substaintí gníomhacha sin a cuireadh ar ais.' 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"
    substaintí ghníomhach a aisghaireadh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Substaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta a aisghaireadh, déanfar iad a shainaithint amhlaidh, agus déanfar iad a leithscaradh go fisiceach nó, má tá córas coibhéiseach leictreonach ar fáil, go leictreonach go dtí go bhfaighfear toradh imscrúdaithe ar na substaintí gníomhacha sin a cuireadh ar ais.' 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"
    zurückgegebener Wirkstoff
    de
    returned active substance
    en
    Definition "active substance of a veterinary medicinal product returned by a customer to an importer or distributor" Reference "COM-EN, based on: 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"
    substance active retournée
    fr
    Definition "substance active d'un médicament vétérinaire renvoyée au distributeur en gros ou, le cas échéant, au fabricant, à l’exploitant ou son dépositaire" Reference "Règlement d’exécution (UE) 2021/1280 de la Commission du 2 août 2021 concernant les mesures relatives aux bonnes pratiques de distribution des substances actives utilisées comme matières premières dans les médicaments vétérinaires conformément au règlement (UE) 2019/6 du Parlement européen et du Conseil"
  16. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #665585

    IATE #3599401
    substaint ghníomhach a diúltaíodh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Substaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta a diúltaíodh, déanfar iad a shainaithint, a rialú, a leithscaradh go fisiceach nó, má tá córas coibhéiseach leictreonach ar fáil, go leictreonach chun a n-úsáid neamhúdaraithe i monaraíocht agus tuilleadh dáileadh díobh a chosc. Beidh rochtain éasca ar na taifid maidir le gníomhaíochtaí díothaithe.' 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 dhiúltaithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    zurückgewiesener Wirkstoff
    de
    rejected active substance
    en
    Definition "returned active substance of a veterinary medicinal product that does not meet all the conditions to be returned to saleable stock by the importer or distributor and must be destroyed" Reference "COM-EN, based on: 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"
    substance active refusée
    fr
    Definition "substance active retournée d'un médicament vétérinaire non conforme aux spécifications établies et refusée" Reference "COM-FR d'après: Règlement d’exécution (UE) 2021/1280 de la Commission du 2 août 2021 concernant les mesures relatives aux bonnes pratiques de distribution des substances actives utilisées comme matières premières dans les médicaments vétérinaires conformément au règlement (UE) 2019/6 du Parlement européen et du Conseil"