Prerequisites to load IMDRF dictionary

About the IMDRF files (till 2024 version)

Note:

This section applies till Argus Safety 8.4.4.

The IMDRF dictionary files are published as separate .xlsx files for Annex A through Annex G.

To load IMDRF dictionaries up to the 2024 version, the ZIP file must include the dictionary .xlsx files for Annex A–Annex G. In each .xlsx file, the first worksheet must have a name that starts with the word Annex (for example, Annex A).

About the IMDRF files (from 2025 version)

Note:

This section applies starting this release, Argus Safety 2026.1.01.
The dictionary file contains a consolidated .xlsx file, where each Annexure A to G is a separate worksheet. Make sure that each worksheet has the following content in the specified order:
  1. Annex Name
  2. Annex Title
  3. Release Number
  4. Annex Description
  5. Annex Instructions
  6. Annex Approval Date

The worksheet names are alphabets like A, B, C, D, E, F and G. Additionally, the excel file name includes the text: Annexes A-G.

Note:

The format of this .xlsx file should not be modified by the user, especially the position of data in columns. If the file format is not as expected, Argus will throw error message prompting the user to reselect correct files.

The user can load IMDRF files with FDA code columns or without FDA code columns. The FDA code columns are FDA Code and NCIt Code. These columns are the additional columns provided by FDA on top of the IMDRF published Annex files.

The file also contains a Status column with the following values:
  • New—A new record to be added
  • Retired / Not selectable—An obsolete record to be soft deleted
  • Modified—An updated record to update the existing record
  • Null—An existing record with no change required

Parent topic: IMDRF dictionaries