Step-by-step guide

Table of Content

Table of Content

Table of Content

File Manager

This section explains how the File Manager in TPD PRO serves as a centralized repository for regulatory documents, enabling organized storage, filtering, XML export, and submission tracking for all required files.

What is the File Manager?

The File Manager in TPD PRO is a centralized document repository used to store, organize, and manage all files required for regulatory submissions. These files are linked to Submissions, Presentations, Ingredients, or Compositions, and must be exported as part of the EU-CEG notification process.

System Categories

TPD PRO uses predefined system categories to classify files for regulatory purposes:

  • Nicotine Test — Nicotine dose uptake reports (typically issued by laboratories)

  • Emission Test — Laboratory test results for emissions

  • Toxicological Data (Tox Data) — Safety data for ingredients

  • Leaflet / User Manual — Consumer-facing product information

  • Packaging — PDF file showing product packaging

  • Sales Mode — Details about the sales model or retail structure

  • Market File — Market research or market studies used in submissions (required in countries that demand sales data)

  • Other — Additional documents such as:

    • Production Process File

    • Opening Refill File

    • Consistent Dosing Method documentation

📎 All files must be uploaded in PDF format (.pdf extension).

How to Use the File Manager

  • Go to File Manager in the left-hand menu

  • Upload files and assign them to:

    • A Submission, Presentation, or Composition

    • A relevant System Category

  • Optionally, create custom folders for internal filtering and organization by project, market, or client

Exporting Files for Submission

All files required for regulatory submission must be exported via TPD PRO in XML format.

You can:

  • Export files individually, or

  • Export files in bulk (e.g., all files for a given Submission or Submitter)

This ensures compatibility with EU-CEG requirements and correct packaging for upload via eTrustEx.

Submission Tracking

After exporting and uploading files to eTrustEx, you should:

  • Mark files as submitted within TPD PRO

  • Clearly track which files have already been sent

  • Prevent duplicate submissions — resubmitting the same file will trigger an error in the EU-CEG system

✅ You can also bulk-mark multiple files as submitted, and export files in bulk for convenience.

  • Filter files by category, linked entity (submission, presentation, composition), date, or submission status

  • Use folders and descriptive file names to manage projects efficiently

  • Monitor the submission status of each file directly in the interface

Important Notes

  • Resubmitting the same file without changing its identifier will lead to a submission error in eTrustEx

  • Always mark uploaded files as submitted to maintain accurate tracking

  • Ensure that all submitted documents are PDF files, clearly categorized, and properly linked to their respective entities in the system