Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #688241

    IATE #3639968
    máistirchomhad breise cáilíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... máistirchomhaid bhreise cháilíochta dá bhféadfaí deimhniú a úsáid chun faisnéis shonrach a chur ar fáil maidir le cáilíocht substainte atá i láthair nó a úsáidtear i monarú táirge íocshláinte ...' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    zusätzliche Qualitäts-Stammdokumentation
    de
    additional quality master file
    en
    Definition master file on an active substance other than a chemical active substance or on other substances present or used in the manufacture of a medicinal product Reference European Commission. DG SANTE. Correspondence dated 16.6.2023
    Comment "'Active substance master file' is only on chemical active substances (Article 25), but in addition to that, the marketing authorisation dossier may rely on an additional quality master file."
    dossier permanent de la qualité supplémentaire
    fr
    Definition dossier permanent relatif à une substance active autre qu'une substance active chimique ou à d'autres substances présentes ou utilisées dans la fabrication d'un médicament Reference COM-FR d'après:correspondance avec les experts de la DG SANTE, Commission européenne
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688338

    IATE #3640684
    deimhniú breise faoin máistirchomhad cáilíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'mar is gá i gcomhréir le hIarscríbhinn II, brath ar mháistirchomhad breise cáilíochta, deimhniú breise faoin máistirchomhad cáilíochta arna dheonú ag an nGníomhaireacht i gcomhréir leis an Airteagal (‘deimhniú breise faoin máistirchomhaid cáilíochta’) nó deimhniú lena ndeimhnítear go bhfuil cáilíocht na substainte gníomhaí lena mbaineann rialaithe go cuí ag an monagraf ábhartha den Pharmacopeia Eorpach.' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    additional quality master file certificate
    en
    Definition certificate granted by the European Medicines Agency in accordance with Article 25 of Directive xxx in cases where the relevant data on an active substance other than a chemical active substance or on other substances present or used in the manufacture of a medicinal product concerned are not already covered by a monograph of the European Pharmacopeia and which can be used instead of submitting the relevant data on such substance required in accordance with Annex II to this Directive Reference "COM-Terminology Coordination, based on: 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"