Delegated directive (EU)2016/161 related document
Calin Lungu
Lead EV and XEVMPD trainer, CTIS master trainer, expert pharmacovigilance auditor (>165 audits), PV QA consultant, CEO of DDCS
Dear colleagues, you will find this document useful in preparation for the implementation of the above mentioned directive's requirements. If you Google it, looking for "EMVO_0122" make sure to download version 2.0 of 19 June 2018. You will find useful Table 2 for market-specific data elements with respect to the XEVMPD EVCode.
As you probably have noticed, the advanced queries in XEVMPD currently do not allow to choose the field "Package description". I have sent earlier today an IT enhancement proposal to the EMA Service desk to add this field. I will keep you up-to-date on the progress and, hopefully, implementation of this proposed enhancement.