EudraVigilance Medicinal Product Dictionary (XEVMPD)
Achieve XEVMPD compliance with expert support
Achieve XEVMPD compliance effortlessly with QbD's expertise. Simplify your regulatory submissions and maintain up-to-date safety profiles with comprehensive EudraVigilance data management services.
What is EudraVigilance and the XEVMPD?
EudraVigilance is the European system for managing and analyzing information on suspected adverse reactions to medicines. The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is the reference database that stores medicinal product information used for electronic ICSR reporting within the EU.
Our EudraVigilance and XEVMPD services include:
- XEVMPD data entry and validation: Accurate registration and maintenance of your product data in the EudraVigilance medicinal product dictionary.
- Prerequisite management: Ensuring all organizational and product prerequisites are in place for EudraVigilance access and reporting.
- Electronic reporting: Submission of ICSRs and other safety reports through the EudraVigilance system.
- Market authorization support: Aligning XEVMPD entries with marketing authorization details to ensure consistency.
- Regulatory updates: Keeping your XEVMPD data current in response to regulatory changes, product modifications, or new marketing authorizations.
- EudraVigilance registration: Supporting the registration process for organizations and products in the EudraVigilance system.
Why are EudraVigilance services essential?
EU regulatory requirement
XEVMPD registration and EudraVigilance reporting are mandatory for all MAHs operating in the European market.
Data integrity
Accurate XEVMPD entries ensure your electronic safety reports are correctly linked to the right products.
Market access
Proper EudraVigilance registration is a prerequisite for marketing authorization and product distribution in the EU.
Operational efficiency
Well-managed XEVMPD data streamlines ICSR reporting and reduces rejection rates.
Ongoing compliance
Regular updates ensure your product data remains aligned with current regulatory requirements.
How can we help?
QbD Group's EudraVigilance services ensure your medicinal product data is accurately managed and your reporting obligations are met:
XEVMPD data management
Comprehensive data entry, validation, and maintenance of your products in the XEVMPD.
System registration
Supporting your organization's registration in EudraVigilance and managing access credentials.
Electronic ICSR submission
Ensuring timely and accurate submission of safety reports through the EudraVigilance gateway.
Prerequisite management
Verifying all organizational and product requirements are in place for compliant reporting.
Regulatory updates
Keeping your XEVMPD entries current with product changes and evolving EMA requirements.
Why QbD Group
Your trusted partner
Choosing QbD Group for EudraVigilance services ensures:
Deep EMA expertise
years of experience navigating the EudraVigilance system and XEVMPD requirements.
Accurate data management
meticulous data entry and validation processes that minimize rejection rates.
End-to-end support
from initial registration through ongoing data maintenance and electronic reporting.
Regulatory currency
proactive monitoring of EMA updates to keep your product data compliant.
Proven reliability
trusted by MAHs across Europe for high-quality EudraVigilance services.
Let's talk Pharmacovigilance
From QPPV services to signal management, our safety experts are ready to support your pharmacovigilance needs.