Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688155

    IATE #3639786
    údarú margaíochta láraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Maidir leis na cláir um rochtain luath sin ar leibhéal na mBallstát, is é is aidhm dóibh rochtain ar tháirgí íocshláinte a sholáthar d’othair i gcásanna ardriachtanas leighis nach bhfuiltear ag freastal orthu sula ndeonófar údarú margaíochta láraithe.' Reference "Rialachán (AE) 2021/2282 maidir le measúnú ar theicneolaíocht sláinte agus lena leasaítear Treoir 2011/24/AE, CELEX:32021R2282/GA"
    centralised marketing authorisation
    en
    Definition marketing authorisation granted in accordance with Regulation (EC) No 726/2004 Reference "Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products"