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  1. 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 Tagairt "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
    Comhthéacs '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.' Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Máistirchomhad Substainte Gníomhaí Tagairt "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 Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Beidh sealbhóir ASMF ionchorpraithe cheana féin i gcórais TF an Aontais lena ndéantar sonraí eagraíochtúla a stóráil agus a sholáthar.' Tagairt "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
    Sainmhíniú beliebtes Instrumentarium für den Wirkstoffhersteller, um seine Informationen vertraulich und nur der Behörde gegenüber zu veröffentlichen Tagairt 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
    Sainmhíniú 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 Tagairt "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"
    Nóta 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
    Sainmhíniú 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 Tagairt "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"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688153

    IATE #3639784
    deimhniú máistirchomhaid maidir le substaintí gníomhacha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Bescheinigung über die Wirkstoff-Stammdokumentation
    de
    active substance master file certificate
    en
    Sainmhíniú certificate granted by the European Medicines Agency (EMA) in accordance with Article 25 of Directive xxx in cases where the relevant data on the active substance concerned are not already covered by a monograph of the European Pharmacopoeia and which can be used instead of submitting the relevant data on a chemical active substance of a medicinal product required in accordance with Annex II to this Directive Tagairt "COM-Terminology Coordination, based on:Proposal for a Directive 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"
    Nóta The active substance master file certificate shall cover all the information required in Annex II on the active substance
    certificat du dossier permanent de la substance active
    fr
    Sainmhíniú certificat délivré par l’Agence conformément à l'article 25 de la directive xxx dans les cas où les données pertinentes sur la substance active concernée ne sont pas déjà couvertes par une monographie de la Pharmacopée européenne et sur lequel peuvent s'appuyer les demandeurs d’autorisations de mise sur le marché, au lieu de fournir les données pertinentes sur une substance chimique active d’un médicament requises conformément à l’annexe II Tagairt "COM-FR d'après: 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"