For EVMPD, regulatory and pharmacovigilance information has to be sent in XML format, together with the SmPC.
Although the time management of the project for data collection and receiving registration status from EMA was a challenge for the entire pharmaceutical Industry, ASPHALION managed to submit all registrations for which authorization was received before 2nd July to EMA.

ASPHALION makes use of Extedo´s MPDmanager for the submission of the data to EMA by using the Gateway. This way, the information is still in-house available and submission can be traced.

For variations, EMA informed Industry that for now variations do not have to be notified, as the process first needs to be clarified. In September a meeting with Industry is planned to discuss the maintenance process in detail.