What is xEVPRM and what is an EV Code?
xEVPRM stands for Extended EudraVigilance Product Report Message. It defines the structure, layout and contents of the file that must be sent to the EMA to populate the xEVMPD. This is a very IT-technical thing that can’t realistically be created manually.
xEVPRM is based on XML files like the eCTD is. XML stands for Extensible Mark-up Language and it’s a way to send structured data around the Internet, a bit like how HTML is the ‘language’ that web sites use to display text and graphics.
How does it work?
Basically your software will gather together all your product licence information and any related data about organisations etc, put it into XML format, and create a ZIP file from it, along with any documents that are also required. Each XML file or document must be less than 25MB and the overall ZIP file must be less than 60MB. You will then send this to the EMA in one of two ways;
- using your Gateway (if you have one)
- or by logging on to EVWEB and using EV WEB Trader Post function to upload and send the file.
Once the EMA receive the file they will process it according to their published rules;
- first their software will check that the XML file structure matches their definition;
- then it will check that their business rules have been obeyed;
- next it will update their database with your valid information, and generate EV Codes for the new records;
- then it will create an acknowledgement file (called an xEVPRM_ACK) that will say which data it found to be valid and which is invalid;
- finally it sends the file back to you using Gateway or EVWEB.
Your software will then read this file and use it to update your database with the EV Codes that it has allocated to your data.
What’s an EV Code?
The EV Code is the unique reference for your product information in their database. When you first send a new record to the EVMPD (a new product licence for example) your software will send it using your local system’s unique key. The EMA will add a new record to their database for this record and allocate it a unique key from their side, for example PRD0005678, and this will be sent back in the acknowledgement file. Your software will then update the EV Code in your database with this information. From then on, whenever a record needs to be updated, your software will send the EV Code in order to identify the record concerned.