On this page: Overview | Summary of requirements
Overview
All dossiers in NeeS format must include a comprehensive table of contents for the complete dossier.
Summary of requirements
| Section | Description | Category 1/COR report-based | Variations to quality only (e.g. Category 3) | ||
|---|---|---|---|---|---|
| New registration | Variation | New registration | Variation | ||
| 1.1 | Comprehensive table of contents (for dossiers not in the eCTD format) | mandatory | mandatory | mandatory | mandatory |
When to include a comprehensive table of contents
Include a comprehensive table of contents in all dossiers in NeeS format.
How to prepare a comprehensive table of contents
The comprehensive table of contents is a complete list of all documents in the dossier, arranged by Module, and with location references for each document.
Specify the titles of studies in the table of contents, indicating the type of study and topic in the title. Study codes alone are not acceptable.
Location reference
All documents in a NeeS dossier should be referenced from a hyperlinked table of contents. Hyperlinks for each document should always be provided to the first page of the appropriate file.
Do not use page numbers for document location as page numbering is at the document level only.