Notes for the example ASMF for eurotriptan maleate

This example ASMF has been provided for illustrative purposes only.  It is not intended to be represent the only acceptable way of presenting the documents that make up an ASMF in eCTD format.

The example is designed to illustrate a typical initial ASMF submission.  The main sections that would usually be populated contain dummy documents.  Certain sections could contain more or fewer documents in other examples.  The eCTD submission for an ASMF amendment could contain content in only some of these sections and may even include other dossier sections (e.g. response to questions).

The exampe eCTD has been created according to the ICH v3.2.2 specification and the EU Module 1 v1.4 specification.  It has been validated against the EU Validation criteria v2.1.

The file and folder naming follow the recommendations described in the guidance document.  The individual PDF files are single page dummy documents and have not necessarily been completed to the full expectations of the CTD/eCTD specification (for example, there is no identifier of the document in the header of the page).  However, most other PDF checks have been completed (e.g. the document opening options, version of PDF, etc.).

The XML files have been completed according to the eCTD specification and the ASMF guidance.  The envelope contains typical metadata for a Centralised Procedure ASMF.  The leaf titles follow the naming convention identified in the guidance.