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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 2B - Medicinal products for human use - Presentation and content of the dossier - Common Technical Document (CTD)
Internet:http://ec.europa.eu/health/files/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf
Origin/Publisher:European Commission; Directorate for Health & Consumers, Brussels
Content:This document provides guidance for the compilation of dossiers for applications for European marketing authorisations according to the CTD format.
Document Type:Notice to Applicants