The Delegated Regulation (2016/161) enforces that each potential incident of falsification is investigated. However, intelligence can be added to support OBPs/MAHs on this.
EMVO will adopt automation processes, which the OBPs can make use of by accessing the AMS Portal. One of them is the following βPotential procedures/technical error at the end-user - X Alerts were raised for the same pack in the last 24 hoursβ.
These alerts can be handled in bulk and removed from the OBP/MAH action list.
This functionality will be implemented in the AMS Clementine release (AMS Hub 3.0.0 AMS Portal 3.0.0), by the end of the first quarter of 2023.
For further clarification on this article please feel free to contact the EMVO Service Desk at helpdesk@emvo-medicines.eu
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