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Mutual recognition procedure generic products

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... [Pg.573]

See other pages where Mutual recognition procedure generic products is mentioned: [Pg.159]    [Pg.498]    [Pg.1982]    [Pg.439]    [Pg.439]    [Pg.439]    [Pg.394]    [Pg.627]    [Pg.627]    [Pg.627]    [Pg.1384]    [Pg.344]    [Pg.344]    [Pg.344]    [Pg.114]    [Pg.1685]    [Pg.66]   
See also in sourсe #XX -- [ Pg.439 ]



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