Søknad om vesentlig endring Rapportering Regelverk og veiledninger Søknad om klinisk utprøving av GMO i legemidler til mennesker Compassionate Use Plan Desentraliserte kliniske utprøvinger Inspeksjon av kliniske studier Oversikt in excess of antallet søkte studier om klinisk utprøving av legemidler Søknad og oppfølging av markedsføringstil
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