Information on the marketing status for CAPs needs to be submitted and kept up to date at all times via an existing process in the IRIS platform. This information will be used in the ESMP for CAPs in scope of the reporting requirements to the ESMP, but it cannot be modified there. If marketing status details for CAPs in IRIS are out of date or incorrect, changes need to be implemented directly in the IRIS platform, after which they will be automatically reflected in the ESMP. Please find more information here: Notifying change of marketing status and here: IRIS guide for applicants.
Information on the marketing status of nationally authorised products (NAPs) will only be requested for a specific group of products in scope of crisis or MSSG-led preparedness reporting, when this is triggered by the MSSG, and submitted via a standalone reporting data flow directly in the ESMP.
The EMA will also work on the long-term strategy for reporting the information on the marketing status of all products via a single submission flow.
For more information, please check the FAQ, Nr. 9, page 4.
