xEVMPD Data Maintenance
EMA published the rules for maintaining EVMPD data during January – April 2014 and the deadline for resubmission – December 2014 – has now passed. For full details see the EMA’s EVMPD documents page and there is practical guidance on how to meet the guidelines in Samarind RMS blog. Here’s a summary.
- Details of new marketing authorisations (MAs) must continue to be submitted within 15 calendar days of approval.
- If there is any change to an MA that affects the xEVMPD data, this should be submitted within 30 days.
- The ‘Update’ operation should be used from now on for all changes, even when a change is a result of a variation.
- EMA staff are now performing a QC exercise and doing detailed checks on all the data that has been resubmitted. They are also correcting any mistakes they find.
- Following EMA corrections, MA Holders who maintain their data in an in-house system must make the equivalent changes in their own data, otherwise further updates will be rejected.
Samarind RMS users are already using the system to keep all their data up to date, and can use Samarind’s xEVPRM Comparison Tool to identify the differences between the data they submitted and that which is currently in the EMA database.
The EMA QC process – does it affect you?
As mentioned above, EMA are currently checking submitted xEVMPD data against the SmPC and other sources and correcting any mistakes that they find. QPPVs are informed when corrections have taken place, however the details of the changes are not given. The MA Holder is not given any explanation for the changes (other than to refer people to the published guidance) and – crucially – once EMA staff have changed a record, their system prevents the MA Holder from changing the data back to what it was previously.
EMA has instructed MA Holders to compare the data they have in any in-house systems with the corrected data in the xEVMPD by using their export facility to get full details of the current state of the data. Unfortunately, checking the resultant XML files manually is a very tedious process and for MA Holders with a large amount of data this could take months. And while the data is not in sync, any required updates will be rejected.
To help with this, Samarind’s xEVPRM Comparison Tool is being made available completely FREE OF CHARGE to holders of European MAs. This invaluable tool helps you to quickly identify the exact changes that the EMA has made, so that you can then either make the equivalent change in your in-house system or contact them to contest the change. For more information please contact us.
Did you use EVWEB?
MA Holders who used EVWEB to enter their data may be interested in Samarind’s xEVPRM Loader tool. This takes a complete set of multiple EVWEB data files and imports them into Samarind RMS. Keeping your xEVMPD data up-to-date is then really easy, plus it has significant labour-saving features like bulk QPPV update.
Did your organisation use EVWEB to submit its xEVMPD data?
Not looking forward to using it for resubmission and maintenance?
MAHs that used EVWEB to submit their data will need to decide whether they want to use EVWEB for resubmission and maintenance or move ahead with adopting a system such as Samarind RMS, which is the leading xEVMPD database system.
Samarind has developed a unique, automated tool for importing complete sets of xEVPRM messages files and associated SmPCs and acknowledgement files into the system. This enables EVWEB users to migrate to Samarind RMS and update their existing data using Samarind’s intuitive, easy-to-use interface and resubmit quickly and easily prior to moving into the maintenance phase.
For more information and/or a demonstration, please contact us today.