Diagrammatic Representation of the Organization of the CTD

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Notice to Applicants
Medicinal products for human use
Presentation and format of the dossier
Common Technical Document (CTD)

This Notice to Applicants (NTA) has been prepared by the European Commission in
consultation with the competent authorities of the Member States, the European Medicines
Agency and interested parties in order to fulfil the Commission’s obligations with respect to
article 6 of Regulation (EC) No. 726/2004, and with respect to the Annex I to Directive
2001/83/EC as amended

Preparing and Organizing the CTD
Throughout the CTD, the display of information should be unambiguous and transparent, to
facilitate the review of the basic data and to help a reviewer become quickly oriented to the
application contents. Text and tables should be prepared using margins that allow the
document to be printed on A4 paper. The left-hand margin should be sufficiently large that
information is not obscured through binding. Font sizes for text and tables should be of a style
and size that are large enough to be easily legible, even after photocopying. Times New
Roman, 12-point font is recommended for narrative text. Acronyms and abbreviations should
be defined the first time they are used in each module.
However when preparing the product information for applications in the centralised procedure
(ref. Module 1.3.) it is mandatory to use the “QRD (Quality Review of Documents)
convention”.
Pagination and Segregation
Every document should be prepared in line with the CHMP /ICH/2887/99 Revision 1
Organisation CTD recommendation.
Information about national administrative requirements
Information about the addresses of the national authorities, the numbers of copies of dossiermodules required, and further information are published by the EC in the NTA, Vol. 2A,
Chapter 7 (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/a/ctd-chap7_2006-
03.pdf).

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Continue at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf

 

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