XEVMPD, EVPRM (EudraVigilance Product Report Message)

Facing an unprecedented timeline for compliance?? We ensure that our PVNET EVPRM solution encompases all the requirements and creates a fully compliant XML for submission of mandated product data!!

PVNET EVPRM is a mainstream solution to populate Medicinal Product Report Message having information of authorized medicinal products and approved substances in EVMPD (EudraVigilance Medicinal Product Dictionary).

PVNET EVPRM is also available on cloud. It also has provision of importing data from of XML, XLS, etc. This approach provides our customers with significant protection in their investment and helps mitigate risk associated with the near term EVMPD challenge.

Key functions in PvNET EVPRM solution:

• Robust data framework which supports XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) and SSI (Structured Substance Information)
• A dynamic user interface
• Multiple data entry mechanism with specific alternatives for products with multiple MAHs
• Works on platform approach based on cloud as well act as a standalone application
• In-built capability of supporting list of controlled vocabularies which is used to encode the product/substance information, such as ATC codes, Routes of Administration, Pharmaceutical Forms, etc.
• Creates zipped package of compliant XML and related attachments which is ready to be transmitted via the EudraVigilance Gateway
• Batch import and processing: XML, Text file, etc.
• Audit trail maintained of all activities done by all users

We also provide services of creating XEVPRM standardized XML, which is also technically compliant for submission to the EudraVigilance system.
More on our EVPRM services, click here...

Our product roadmap for XEVMPD is clearly defined and will deliver a high-quality solution within a comfortable timeframe before the mandate is finalized.