Virginia Rojo Guerra

When a presentation is reported as Marketed for the first time in a MS, the Date of marketing status change becomes the Date of initial placing in the market. This is explained in the regulatory guidance Notifying a change of marketing status | European Medicines Agency (europa.eu) question 6: Presentations of a CAP already on the market: status should be reported as ‘Marketed’ with the date of the initial placing in the market as ‘Date of Marketing Status change’. This will become the ‘Date of initial placing in the market’ once the submission is processed.

This date will remain fixed and subsequent changes in the marketing status won't change this initial date. This is why is important that for products that have the status as No data provided, the baseline should be an initial reporting as 'Marketed' to include the Date of first placing in the market. This date should be the date of launch of that presentation in the MS.  After this first reporting, the MAH can report the cessation with the future date.

If you report a cessation with a date in the future, the fields for future dates will be visible in the Report. This allows to see the current and future marketing status and make searches for future dates.

The real date of initial placing in the market should be reported for all products, also for the ones authorized before 20 November 2005.

For products that have never been on the market, a new functionality is being implemented. A reason for cessation "Never marketed" will be included in the list of reasons and should be visible when reporting" Not marketed" in the context of a baseline submission. This is under implementation and should be in production within a few weeks. For now, you could either delete all the lines with "No data provided" in the Excel file or leave them as is, but avoid reporting a status as "Not marketed" while leaving the date blank: doing so would trigger a validation error.

For bulk notifications that were closed with no errors, if the marketing status report is not showing the reported data correctly, please create an EMA Servicedesk ticket (incident). They should be able to investigate the case. Please include the case number in your request.

The ISO codes have been updated in the system and Greece should show as EL. For bulk uploads, please use the excel file that is downloaded from the IRIS system directly on “Download Current Marketing Status” once you select the authorized product, when doing a bulk submission. We are updating the guidance to remove the reference to the other template.

It is not possible to correct a "false entry". If the wrong date for a cessation has been entered, a new submission, with the correct date, is needed to replace it. If "Date of initial placing in the market" has been wrongly entered, you need to create an EMA Servicedesk ticket (incident) to address the issue and have the date changed from the back end.

It should only take a few minutes for you to receive confirmation that the change has been successful or there has been an error. Similarly, a successful change should be visible in the Report within minutes.