The expected timeframe for responding to or handling an alert may depend on the requirements applicable in the country where the alert was raised.
The EAMS includes an Alert Due Date to help OBPs prioritize alerts. In the AMS Portal, alerts can be prioritized based on the remaining time before their due date:
For the applicable response timeframe in a specific market, users should refer to the latest official guidance issued by the relevant national organization or competent authority. For further information regarding national regulations, please contact the relevant NMVO.
For further clarification on this article please feel free to contact the EMVO Helpdesk.
Email: helpdesk@emvo-medicines.eu
Phone no: +32 2 657 00 08