Ennov InSight XEVMPD

Ennov InSight XEVMPD is designed to support a standardized and structured method of collecting, reporting, coding, and evaluating authorised medicinal product data. You can then use this data to submit medicinal product information to the European Medicines Agency (EMA).

The Ennov InSight XEVMPD module enables you to capture, maintain, and submit data about pharmaceutical products to comply with the Extended EudraVigilance Medicinal Product Database (XEVMPD) directive.

Your organization can use Ennov InSight XEVMPD to gather the data needed for submission in an XML file, which is referred to as the Extended EudraVigilance Product Report Message (XEVPRM). You can then create a .zip file that includes the XML content and electronic files of required attachments referenced in the XML file to transmit to the EudraVigilance system.

With the XEVMPD license, you can also access the XEVMPD Submissions - QC Verification and XEVMPD Submissions and Acknowledgements query reports. For more information, see Submission Planning and Tracking Queries in the Ennov InSight Registrations online help.