Guidance on the Electronic Submission of Information on Investigational Medicinal Products for Human Use in the Extended Eudravigilance Medicinal Product Dictionary (XEVMPD)

The guidance document for electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) has been updated with several enhancements to streamline submissions and improve compliance.

Key Updates:

• Initial Submission Requirements:
  • Includes details on the initial submission of a reference source and sponsor information content.
  • Adds provisions for submitting a standard or proposed Anatomical Therapeutic Chemical (ATC) code.
• Annex Sections:
  • A new Annex outlines pre-submission requirements to ensure readiness before data entry.
  • Another Annex provides referencing guidelines for pharmaceutical form terms, routes of administration, and ATC codes.
• Comprehensive Content Coverage:
  • Glossary and Introduction: Offers definitions and an overview of the submission process.
  • Pre-Submission Requirements: Details necessary preparations before data submission.
• Data Submission Process:
  • Covers the initial submission of Detailed Medicinal Product (DMP) information.
  • Includes specific fields for active substance and excipient data.
  • Addresses the ATC code submission process.
  • Incorporates reference source submission guidelines.
• Data Maintenance and Validation:
  • Specifies procedures for maintaining up-to-date medicinal product information.
  • Provides criteria for validating submitted DMP data.
• Additional Enhancements:
  • Emphasizes referencing pharmaceutical form terms and routes of administration.
  • Introduces mechanisms to ensure accurate and consistent data submissions.

These updates aim to facilitate the accurate and efficient submission of investigational medicinal product data while aligning with regulatory standards and improving overall data quality.

Region: EU Harmonized (27 Markets)

Source: https://www.ema.europa.eu/en/documents/other/guidance-electronic-submission-information-investigational-medicinal-products-human-use-extended-eudravigilance-medicinal-product-dictionary-xevmpd_en.pdf