Challenge

To perform a Periodic Safety Update Report (PSUR) in the European Union for a product which was not registered in the eXtended Medicinal Product Dictionary (XEVMPD) after recent marketing authorisation transfer. 

Approach

Following marketing authorisation transfer of a product, the pharmacovigilance provider had not updated the XEVMPD for the product. The consequence of this is that the PSUR cannot be submitted through the European Medicines Agency (EMA) – eSubmission Portal. The is due to the details of the product do not appear within the European Medicines Agency (EMA) PSUR Repository – Delivery File User Interface (UI) and therefore cannot be selected to generate a delivery file. 

As with all PSURs submitted by EUDRAC, the check of the creation of a delivery file is checked well in advance of the PSUR due date and this issue was highlighted to the client. There was therefore chance to make the necessary updates to the XEVMPD and for the submission to be performed within compliance timelines.

Conclusion

It is very important to ensure that the XEVMPD is up to date for all authorised and developmental products. The XEVMPD is integrated into the EU system and other systems (i.e. the PSUR repository and EudraCT Clinical Trial Application form) rely on this data.
In addition, it is also worthwhile to check that submissions portals and repositories can be accessed and used well in advance of any due dates.