Gaois

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

    #663524

    IATE #3589786
    nós imeachta simplithe Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Ba cheart nós imeachta simplithe a chur i bhfeidhm i gcás ina ndéantar an deimhniú ar chineálscrúdú AE a athnuachan i gcás nach ndearna an monaróir modhnú ar an gcineál formheasta agus ar na caighdeáin chomhchuibhithe nó i gcás nár athraíodh sonraíochtaí teicniúla eile a chuir an monaróir i bhfeidhm agus go leanfaidh siad ar aghaidh ag cloí leis na ceanglais sláinte agus sábháilteachta atá riachtanach i bhfianaise staid na teicníochta.' Reference "Rialachán (AE) 2016/425 maidir le trealamh cosanta pearsanta agus lena n-aisghairtear Treoir 89/686/CEE ón gComhairle, CELEX:32016R0425/GA"
    zero day procedure | simplified procedure
    en
    Definition "fast track mutual recognition procedure in order to get a marketing authorisation in a member state (concerned Member State, CMS) of a medicinal product which is already authorised in another member state (reference Member State, RMS) when there is only one CMS and where the medicines authority of that CMS has agreed in advance to accept the assessment of the RMS, without any comments or questions" Reference "COM-Terminology Coordination, based on:1) Lyfjastofnun/Icelandic Medicines Agency. 'How to increase the number of authorised and marketed medicinal products and veterinary medicinal products in Iceland?' (19.5.2020), 4 September 2013.2) Heads of Medicines Agencies (HMA). > 'Medicines Approval system > What is the Mutual Recognition procedure?' (19.5.2020)"