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at rekvirent søker om godkjenningsfritak hos Direktoratet for medisinske produkter i forkant av behandling.En legeerklæring på norsk til tollvesen og politi der norsk lege bekrefter at pasienten er under behandling av nederlandsk lege etter anbefaling fra norsk lege. Det må fremgå av erklæringen at pasienten har et medisinsk behov for den akt