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Natio­nal Aut­ho­ri­ties

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The natio­nal aut­ho­ri­ties moni­tor the func­tion of the data repo­si­to­ries and inves­ti­ga­te suspec­ted fal­si­fi­ca­ti­ons for which hand­ling and tech­ni­cal errors were pre­vious­ly excluded. In addi­ti­on, the pre­vious moni­to­ring of the mar­ket par­ti­ci­pan­ts is exten­ded to com­pli­ance with the Fal­si­fied Medi­ci­nes Direc­ti­ve and the Dele­ga­ted Regu­la­ti­on.