Gaois

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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

    #668040

    IATE #3629767
    an t-údarás um tháirgí íocshláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Tabharfaidh an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis a thuairim don chomhlacht dá dtugtar fógra laistigh de 210 lá tar éis dó doiciméadacht bhailí a fháil.' Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle,CELEX:32017R0745/GA"
    medicinal products authority
    en
    Definition competent authority designated by the Member States in accordance with Directive 2001/83/EC Reference "Proposal for a Regulation of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council, COM(2022) 721 final."