As follow up of the last EMA/Industry Platform meeting on the centralised procedure on 01.12.2021, this update is to communicate an extension of the timelines in the implementation plan for IRIS Marketing status from 6 to 9 months.

The Agency is analysing the feedback provided by industry and fixing some technical issues in the ´bulk submission´ to ensure the correct upload of all data for marketed CAPs. This submission type is the most widely used by MAHs to report the current marketing status of medicinal products currently markted in the EU/EEA MS.

The new deadline for the submission of the Marketing status data for all presentations of each CAP in the EU/EEA MS is 30.04.2022 (prev. 31.01.2022).
We encourage MAHs to continue gathering the data to be reported and to submit as soon as possible.

The regulatory guidance will be updated in January to reflect the change in the deadline.

For any technical query related to a specific IRIS marketing status submission, please do not hesitate to contact the Agency through EMA ServiceDesk Portal.

For more information follow the links below: