Gaois

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2 results

  1. INDUSTRY|chemistry

    #616534

    IATE #950437
    démheitiolformaimíd Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déantar an t-aicrileach, an modaicrileach nó an clórashnáithín a thuaslagadh as mais thirim aithnid den mheascán le démheitiolformaimíd atá téite i ndabhach uisce atá ag an bhfiuchphointe.' Reference "Rialachán (AE) Uimh. 1007/2011 maidir le hainmneacha snáithíní teicstíle agus maidir le lipéadú gaolmhar agus marcáil ghaolmhar táirgí teicstíle i leith a gcomhdhéanaimh shnáithínigh agus lena n-aisghairtear Treoir 73/44/CEE ón gComhairle, Treoir 96/73/CE ó Pharlaimint na hEorpa agus ón gComhairle agus Treoir 2008/121/CE ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32011R1007/GA"
    Dimethylformamid
    de
    dimethylformamide | N,N-Dimethylformamide | DMF
    en
    Definition organic compound with the formula (CH3)2NC(O)H Reference A common solvent for chemical reactions that is often abbreviated as DMF.
    Comment "Wikipedia > Dimethylformamide (23.12.2020)"
    diméthylformamide | N,N-diméthylformamide | DMF
    fr
    DMF
    mul
  2. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #682053

    IATE #3503253
    Máistirchomhad maidir le Substaintí Gníomhacha 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 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"