Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #642909

    IATE #3510052
    máistirchomhad plasma Reference "Togra le haghaidh Rialachán maidir le caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoracha 2002/98/CE agus 2004/23/CE, CELEX:52022PC0338/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Plasma Master File | PMF
    en
    Definition stand-alone documentation, which is separate from the dossier for marketing authorisation which provides all relevant detailed information on the characteristics of the entire human plasma used as a starting material and/or a raw material for the manufacture of sub/intermediate fractions, constituents of the excipient and active substance(s), which are part of medicinal products or medical devices referred to in Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or human plasma Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"
    dossier permanent du Plasma | DPP
    fr
  2. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #668062

    IATE #3629841
    cigireacht shainiúil maidir le máistirchomhad plasma Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Le haghaidh aon chigireacht shainiúil maidir le Máistirchomhad Plasma laistigh nó lasmuigh den Aontas, beidh feidhm ag táille EUR 36 100. Beidh an luach saothair cothrom le EUR 13 400 le haghaidh an phríomhúdaráis maoirseachta agus le EUR 8 200 le haghaidh an údaráis maoirseachta tacaíochta.' 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"
    Plasma Master File inspection
    en
    Definition "pre-approval or post-approval inspections of the blood establishments in which collection, testing, processing, look back, storage and distribution is carried out under the 'Plasma Master File (PMF)' certification system" Reference European Commission. DG SANTE. Correspondence dated 7.11.2022