Søknad om vesentlig endring Rapportering Regelverk og veiledninger Søknad om klinisk utprøving av GMO i legemidler til mennesker Compassionate Use System Desentraliserte kliniske utprøvinger Inspeksjon av kliniske studier Oversikt over antallet søkte studier om klinisk utprøving av legemidler Søknad og oppfølging av markedsføringstillatels
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