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Where can I find information on national requirements for eCTD in European Union countries?

April 26, 2017countries ectd European National requirements Union

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Where can I find information on national requirements for eCTD in European Union countries?

1 Answer

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10 Posted

With great difficulty! Information in Chapter7 of the Notice to Applicants is generally inadequate, and the websites of individual European agencies (see Heads of Agencies website for links) do not always provide information regarding requirements for electronic submissions. The EMEA website provides useful links to individual agencies that do provide guidance on their websites.