The Agency is aware that some MAHs are experiencing a delay in the time that it takes for the Marketing Status bulk notifications to be processed and closed. The validation is performed automatically by the system with no manual intervention and we are experiencing some unexpectedly long processing time. We are actively working to solve the issue. We want to reassure all MAHs that baseline notifications are accepted even if the formal deadline has past.
Equally, it has been identified that a few newly authorized products/product presentations are not visible in IRIS. A new routine for data integration is expected to be deployed within the next couple of weeks to improve data integration between the systems. If the absence of a product/presentation is preventing you from reporting the Marketing Status, please raise a ticket through the
EMA ServiceDesk Portal.
Your ticket will be responded to once the issue is sorted so that you can proceed with the reporting. In case of a technical issue preventing any MAH from reporting the Marketing Status, the baseline can still be reported within 2 weeks after the EMA Service Desk ticket being solved.
