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APPLICATION FORM
SUMMARY OF THE DOSSIER
APPLICATION FORM : ADMINISTRATIVE DATA
The application form is to be used for an application for a marketing authorization of a medicinal product
for human
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What is summary of form dossier?
Summary of form dossier is a condensed overview of the information contained in a dossier.
Who is required to file summary of form dossier?
All individuals or entities required to submit a dossier must also file a summary of form dossier.
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The summary of form dossier is usually completed by providing key details and information in a concise manner.
What is the purpose of summary of form dossier?
The purpose of the summary of form dossier is to provide a quick reference to the essential information contained in the full dossier.
What information must be reported on summary of form dossier?
The summary of form dossier should include key points, highlights, and key findings from the dossier.
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