Dossier Preparation

A modular approach

The VCP Dossier Requirements follow a modular approach which is:

  • informed by eCTD and OECD standard dossier formats;
  • easier to submit electronically;
  • more efficient to screen for completeness;
  • easier to provide the data to the appropriate experts; and
  • contributing to collaboration and standardization.

NOTE: The modular approach is not a new requirement, it is simply the format in which the requirement information is communicated to WHO.

All information must be submitted in English.

It comprises six modules: