Guidance on Electronic Submission of Medicinal Product Information to EMA (Article 57(2), Regulation EC 726/2004, Chapter 3.I: XEVPRM Technical Specifications)

Guidance on Electronic Submission of Medicinal Product Information to EMA

This document outlines the process for the electronic submission of medicinal product information to the European Medicines Agency (EMA), focusing on compliance with pharmacovigilance requirements using the XEVPRM schema.

Key Highlights

• Purpose and Framework
  • Provides background on the legislative framework governing the submission of medicinal product information and pharmacovigilance.
  • Facilitates compliance with EU requirements for medicinal product data submission.
• XEVPRM Schema
  • Details the technical specifications and version history of the schema.
  • Outlines the structure and elements of the schema, including the use of business rules and tables to manage data elements.
• Submission Process
  • Covers processes for initial submissions and the ongoing maintenance of medicinal product data.
  • Includes guidance on submitting data for Investigational Medicinal Products (IMPs), as required by related documents.
• Database Integration
  • Explains the use of global keys, such as the EV Code, for linking and managing different entities within the database.
• XEVPRM Structure
  • The schema consists of 10 sections, each addressing specific aspects of medicinal product data submission.

This guidance serves as a comprehensive resource for ensuring accurate and compliant submissions of medicinal product information to the EMA, supporting effective pharmacovigilance and data management.

Source: https://www.ema.europa.eu/en/documents/other/chapter-3ii-xevprm-detailed-user-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf

Region: EU Harmonized (27 Markets)