xEVMPD / ISO-IDMP - data entry in the European Database

Due to the current legal situation, all pharmaceutical companies are obliged to submit product information from authorized or registered medicinal products to the EudraVigilance Medicinal Product database respectively xEVMPD database (known also as Article 57 database)

xEVMPD stands for Extended EudraVigilance Medicinal Product Dictionary – basically it’s part of European Medicine Agency’s  system. 

We support you with the required data entry according to the current legal requirements.

We offer:     

• Checklist of required information     
• Data entry
• Evaluation of the Acknowledgments 
• Update and version control
• Documentation

Quality Assurance and Update

• Assessment and evaluation of current status
• Implementation

IDMP system

• The process for updating the EVMPD will be in force until the new ISO IDMP system is in place - coming soon.
• We would be glad to support you any time to comply with Article 57 requirements.