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

Due to the current legal situation, all pharmaceutical companies are requested 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.

CSO team of EMA-experienced users

Our experienced team of EMA-certified users: In the "new reporting procedure", the report is sent directly from and to the EudraVigilance system. This is only possible if the individual pharmaceutical company is registered in the EudraVigilance system and the products or data records are entered in the system.

The individual xEVMPD data sets contain the currently valid SPC or PIL as well as various information such as ingredients and indication for each drug in a coded form and, if applicable, for each pack size.

CSO Pharma offers competent support: Our experienced team of EMA-certified users take care regarding creation and maintenance of all records and their subsequent update in due course and as required.

xEVMPD - traditional herbal medicines

XEVMPD applicable also for traditional herbal medicines: Now all registered, traditional herbal medicines must also be recorded and maintained in the xEVMPD or "Article 57 Database" (Publication of the European Medicines Agency on March 1, 2017).
Until now, only the data of approved drugs had to be recorded and maintained in the "Article 57 database". For registered homeopathic medicines, the xEVMPD entry remains optional.

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